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OUR CURRENT CAREER OPPORTUNITIES

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As an Essential Service Provider, our positions remain open and available

With an emphasis on personal growth and development, BioPharma Services strives to create an environment where our people matter. Everything we do – and we do it with passion – is to improve the quality of life for patients who benefit from the clinical trials that we perform for global pharmaceutical companies.

Our BioPharma family is key to our success. We create an environment where the brightest minds have space to innovate. Where there are always new opportunities to learn and grow. Where you can feel at home. Our award-winning dynamic teams, specializing in the conduct of Phase I/IIa and Bioequivalence clinical trials, are at the forefront of medical research advances every day. Could this be the right place for you?

Review our currently available opportunities and explore the possibility of becoming a part of our community of Clinical Research Professionals.

Diversity & Inclusion

BioPharma Services is committed to creating an inclusive workforce that encourages, supports and celebrates the diverse voices of our employees from any background. We believe diversity and inclusion drives innovation and makes our company stronger. Our objective is to hire great people and build a culture where difference is valued.

  • IN TORONTO, ONTARIO
  • IN ST. LOUIS, MISSOURI
Toronto, Ontario - Early Phase Study Manager
Job title
Toronto, Ontario – Early Phase Study Manager
Duties and Responsibilities
  • Independently conducts, coordinates, monitors and manages all study activities to ensure proper execution of assigned Phase I/IIa clinical research trials (complex SAD/MAD, Human Abuse Potential/Liability, etc.) and to ensure that study protocols, BPSI SOPs, ICH-GCPs and regulatory requirements are met
  • Acts as a Leader by advising CRCs, Study Preparation Associates, Clinical Research Technicians, and Safety Staff on proper trial execution based on protocol, SOP, and regulatory requirements
  • Conducts staff training to ensure proper trial execution
  • Conducts protocol training for Clinical Operations staff
  • Communicates directly with Investigators, study monitors, Sponsors and regulatory agencies as appropriate, and addresses any issues
  • Acts as a central communication point for any study requests and clinical queries from BPSI departments to Sponsors on the status of their early phase studies
  • Acts proactively to ensure the study timelines are met as per internal procedures and Sponsor requirements
  • Liaise with the Sponsor during the planning process and protocol development to ensure that BPSI understands and has planned to meet their expectations
  • Participates in review and development of study protocols
  • Participates in development, revision and implementation of clinical, general and other applicable SOPs, Directives and internal procedures as required, ensuring consistency with GCP, regulatory, and/or Sponsor requirements
  • Reviews with high degree of attention to detail the subject files, study documentation, CRFs and source documents
  • Maintains adequate, accurate, complete and legible study records
  • Works with QC and QA during audits and audit follow-ups
  • Analyzes and develops action plans to address QA findings, including development of CAPA reports
  • Maintains a high degree professional knowledge of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
  • Provides limited supervisory support to department manager as required
  • Performs other tasks as assigned and as training and experience allow
Qualifications
  • Completed Bachelor in a science or healthcare related discipline, or equivalent work experience.
  • At least 2-4 years’ work experience in Phase I/IIa clinical trials as a Clinical Research Coordinator or similar role.
  • Certification in Clinical Research is an asset.
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements.
  • Excellent communication, leadership, time management, problem solving, multitasking and interpersonal skills.
  • Ability to work in a fast paced environment with a high degree of organization.
  • Excellent in Microsoft Word and Excel
Application Process
Apply on LinkedIn

 

Toronto, Ontario - Bioanalytical Chemist
Job title
Toronto, Ontario – Bioanalytical Chemist
Position Summary
Under the direction of the Departmental Manager, performs method validation and biostudy analysis tasks in order to generate analytical test results in compliance with all current applicable Standard Operating Procedures.
Duties and Responsibilities
  • Performs method validation and biostudy analysis tasks in accordance with SOPs.
  • Has a good knowledge of analytical laboratory equipment’s common in the Bioanalytical Laboratory such as sample preparation equipment, general Laboratory equipment and LC-MS/MS.
  • Conduct all work in a good team environment focusing on meeting project timelines.
  • Provides assistance to plan and coordinate projects with responsibility to accommodate frequently changing priorities.
  • Generates analytical test results in compliance with all current applicable Standard Operating Procedures.
  • Generates method procedures, results, validation, re-validation and analytical reports for direct submission to regulatory authorities.
  • Coordinates projects and work activities with Laboratory Management to meet established objectives.
  • Shows innovation on an ongoing basis to assist management in solving problems related to any bioanalytical issues and laboratory processes.
  • Provides assistance in troubleshooting and maintenance of laboratory equipment
  • Assists in reviewing Standard Operating Procedures.
  • Demonstrates excellent written and verbal communication skills.
  • Performs the job in a cost-effective manner.
  • Compiles and archives study/validation data.
  • Performs the job according to an approved Protocols and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
  • Works in a safe manner, complying with all relevant safety procedures and requirements.
  • Exhibits good interpersonal skills, a professional attitude and motivation to produce consistently high quality work.
  • Performs other related duties assigned by the management.

In addition to General Responsibilities, the following are additional responsibilities in regards to the conduct of GLP and Non-GLP studies:

 

  • Generates analytical test results in compliance with all current SOPs, protocols, study plans and applicable GLP (OECD), EMA, ICH, FDA and TPD requirements.
  • Documents and communicates any deviations to these instructions directly to the Principal Investigator (for GLP studies) or Study Director (for Non-GLP studies).
  • Records raw data promptly and accurately and in compliance with the OECD Principles of Good Laboratory Practice.
  • Exercises health precautions to minimize risk to him/herself and to ensure the integrity of the study. Communicates to the Laboratory Management any relevant known health or medical condition so he/she can be excluded from operations that may affect the study.
Qualifications
  • B.Sc. or College Diploma in Analytical chemistry or related subject
  • Minimum of 1-3 years of related experience
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

Apply on LinkedIn

 

Toronto, Ontario - Project Director
Job title
Toronto, Ontario – Project Director
Position Summary
Reporting to the Director of Project Management, the Project Director will provide integrated direction, management and leadership in the administrative and project planning, budgeting, and process improvement efforts of Phase I studies and Key Accounts impacting core functions and components across the organization.
Duties and Responsibilities
  • Directs and integrates the activities of multiple, major project operations; manages a diverse team of professional and support staff, both directly and through managers and/or supervisors.
  • Participates and oversees the development, implementation, and maintenance of individual project objectives.
  • Leads the development of processes and procedures for Phase I projects and its execution as directed by Director of Project Management.
  • Working under the direction of the Director of Project Management champions change and effectively manages the implementation of new strategic ideas and key process improvement initiatives within department or across operational segments of Bio Pharma Services Inc.; achieves excellence in all areas of business.
  • As needed or assigned, acts as a support/backup to Director of Project Management.
  • Supports and solicits input from team member at all levels within the organization.
  • Continuously defines ways to increase client satisfaction and deepen client relationship; ensures service delivers superior satisfaction to clients and provides senior level resolutions.
  • Lends expertise to internal teams and enforces current policies and procedures.
  • Grows long-term relationship with clients and capitalizes on potential opportunities.
  • Provides leadership and guidance in all aspects of the project life cycle.
  • Maintains a tracking process for the studies managed, including initiation, tracking, timelines reporting, budgeting and report writing.
  • Within scope of position, provides sound scientific advice to clients either directly or via other BPSI staff; co-ordinates teleconferences with appropriate personnel, addresses client questions, concerns and/or comments.
  • Negotiates client’s milestones and assist internal stakeholders as required.
  • Uses appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Director, Project Management and/or Operations Management.
  • Actively participates in the weekly tracking meeting to ensure project timelines are current with the most up-to date information from operations and to update operational team of any new information available from the client.
  • Leads feasibility assessment of complex Phase I projects with key department stakeholders; provides support in the review and development of proposals on as-needed basis.
  • Proactively recognizes any change in scope; collaboratively works with Contracts & Proposals team and Business Development to develop and ensure timely completion and issuance of change orders.
  • Follows with existing accounts on new business opportunities and manage activities around outstanding proposals and contracts.
  • Assists in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion.
  • Ensures appropriate documents have been reviewed and circulated within BPSI prior to providing to clients.
  • If required, assists in promotion of BPSI at industry meetings and conferences.
  • Maintains a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, NMPA, ANVISA) and understanding of basic pharmacokinetics and statistics.
  • Coordinates client visits and follow up on requested documents from clients including, but not limited to, regulatory documents, study documents, validation report and brochures.
  • Performs miscellaneous job-related duties and other task as assigned.
Qualifications
  • Bachelor of Science (B.Sc.) degree or equivalent; at least 5 year of experience directly related to the duties and responsibilities specified.
  • Relevant background in the healthcare and/or pharmaceutical industry.
  • Minimum of 5 years’ experience in a senior project management role in either Phase I/BE or Phase I – IV setting.
  • Excellent understanding of how studies are run and how they are managed.
  • Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments.
  • Excellent interpersonal, communication and presentation skills.
  • Strong organizational skills with the ability to adapt and adjust to changing priorities, apply and problem-solving skills.
  • Demonstrated ability to independently manage multiple projects simultaneously.
  • Highly proficient with Microsoft Office Suite (Word, Excel, PowerPoint, MS Project).
Application Process
Apply on LinkedIn

 

Toronto, Ontario - Senior Medical Writer
Job title
Toronto, Ontario – Senior Medical Writer
Position Summary
The Senior Medical Writer will operate within the Medical Writing team. Will be required to develop and maintain Quality Control systems and review Clinical Reports for completion, clarity and compliance with different Regulatory authorities. Lead the required update of the medical writing templates. Assist the Junior Medical Writers with the more complex Clinical Reports and conduct training, as appropriate.
Duties and Responsibilities
  • Write and/or review final Clinical Study Report(s) in compliance with the internal SOPs and the guidance of different regulatory authorities (TPD, FDA, EMA, etc.).
  • Ensure the writers’ compliance with different clients’ specifications for all the documents generated by the Medical Writing team.
  • Conduct and maintain the required training for junior Medical Writers.
  • Assist in the development of the document templates, relevant Standard Operating Procedures (SOPs) and guidelines.
  • Work closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).
  • Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other applicable guidelines.
  • Conduct all work in compliance with SOP’s, GCP and to observe all regulatory guidelines.
  • Negotiate timelines with external departments.
  • Compile study documents, as required.
  • Photocopy and scan study documents.
  • Perform other work as assigned.
Qualifications
  • Minimum university degree, B.Sc. (i.e. Life Sciences)
  • At least 2 years of experience in CRO clinical study report writing, preferably of Phase I and Bioequivalence studies
  • Good interpersonal and communication skills
  • Attentive to details, good initiative and able to work with changing priorities
Application Process
Apply on LinkedIn

 

Toronto, Ontario - Clinical Research Technician
Job title
Toronto, Ontario – Clinical Research Technician
Position Summary
Perform all delegated/assigned medical screening tasks in compliance with study protocol, SOPs, GCP and regulatory requirements.
Duties and Responsibilities
  • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
  • Obtain written informed consent from potential subjects.
  • Record medication/smoking/substance use history, medical/surgical history and demographic information based on the interview with the potential subject.
  • Review Inclusion/Exclusion criteria and compliance check for potential subjects.
  • Obtain Vital Signs and perform electrocardiogram (ECG).
  • Conduct study initiation meeting as assigned
  • Assist other medical screening staff in accurate and timely completion of required tasks.
  • Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI)
  • Collect/process blood and urine samples, conduct screening for drugs of abuse and cotinine, perform breath alcohol test and any other medical screening related activities as required.
  • Perform screening reception duties as required, including but not limited to ID verification.
  • Accurate and timely completion of all applicable medical screening records in compliance with the study protocol, SOPs, GCP/GDP and regulatory requirements.
  • Assist in clinical study tasks as required during clinical conduct
  • Assist in training staff in screening tasks and clinical tasks
  • Perform data review of the medical screening source and/or other related documents as required.
  • Perform data entry/transcription (e.g. CRF completion) as required.
  • Write and/or review source documentation forms
  • Checking the eligibility of transfer of potential subjects from one study to another
  • Performs other tasks and projects as assigned
Qualifications
  • Non-Ontario Medical Doctor with a diploma from an institution recognized by WHO
  • Experience in medical practice
  • 1-2 years of recent phlebotomy and ECG experience
  • 2 year Medical Technology Diploma or equivalent
  • Current BCLS & First Aid certification
  • Strong organizational, time management and planning skills to work independently with efficiency and accuracy
  • Strong team player with ability to multi-task in a fast-pace environment
  • Excellent interpersonal and public relation skills
  • Experience in dealing with and handling confidential information
  • Proficiency in English, with excellent oral and written communications skills
  • Proficiency in Microsoft Word and Microsoft Excel
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com
Toronto, Ontario - Registered Nurse
Job title
Toronto, Ontario – Registered Nurse
Position Summary
To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.
Duties and Responsibilities
  • Perform ECG, Vital Signs, obtain blood sample and study specific testing
  • Obtain Medical History and Informed Consent from potential trial subjects
  • Obtain Informed Consent as appropriate
  • Explanation of the use of study drug(s)
  • Dispense and Administer study drug(s)
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event Reporting
  • Catheter insertion and removal
  • Perform drug/cotinine screen and alcohol test
  • Proper collecting, handling and processing of PK samples
  • Monitor and maintenance of Crash Cart
  • Cardiac Monitoring (Telemetry) (RN & Paramedic only)
  • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
  • Maintain accurate, complete, legible and timely data entry
  • Write and/or review source documentation forms
  • Serve and/or monitor meals
  • Performs other tasks and projects as assigned
Qualifications
  • Education: RN with current registration with regulatory body in Ontario.
  • Current BCLS/ ACLS & First Aid certification.
  • Skills: Good interpersonal skills, good communication skills.
  • Attentive to details, good initiative and able to work with changing priorities.
  • Computer skills an asset.
  • Ability to accommodate a flexible work schedule
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

Toronto, Ontario - Facility Cleaner
Job title
Toronto, Ontario – Facility Cleaner
Position Summary
Shift Flexibility: Mornings 6:00am-2:00pm / Afternoons 14:00-22:00 / Night Shift 22:00-6:00 / Weekends

Cleaners are responsible for ensuring that the entire building is kept in a reasonably clean manner, at all times. They must follow their scheduled shifts and prioritize duties accordingly. Most importantly, they are to report all concerns immediately to a supervisor.

Duties and Responsibilities
  • Washrooms are first priority at the beginning, during and before finishing every shift. If there is a study in progress then this is the starting point of the shift.
  • Ensure all work is done with consideration to health and safety with regards to yourself and all others.
  • Consistently inspect the entire building for cleanliness
  • Dispose garbage from all rooms throughout the building
  • Ensure all the furniture is kept clean
  • Sweep and mop floor surface of the entire building including staircases
  • Ensure all carpets are vacuumed regularly
  • All glass is to be kept clean
  • All doorknobs, walls and countertops are to be wiped
  • Clean lunch room daily as often as necessary
  • Keep outside the building grounds and parking lot clean
  • Seasonal ice/snow remove salt
  • Making of beds throughout Clinic Dormitories
  • Report all problems and concerns to your supervisor, if a concern needs immediate attention and your supervisor is not available please inform an available supervisor
Qualifications
  • Minimum High School or equivalent
  • Minimum 1-3 years prior work experience performing related or similar duties
  • Must be able to lift 50 lbs, bend, reach, climb stairs and stand for extended periods of time
  • Scheduling Flexibility:**
    • Must be available to work day, afternoon and weekend shifts (variable shifts) based on business needs. **
  • Hard-working individual
  • Good communication skills
  • Professional mannerism
  • Ability to prioritize assigned tasks
  • Able to multi-task
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

Toronto, Ontario - Medical Writer
Job title
Toronto, Ontario – Medical Writer
Position Summary
Duties and Responsibilities
  • Write and/or review final Clinical Study Report(s) in compliance with the internal SOPs and the guidance of different regulatory authorities (TPD, FDA, EMA, etc.).
  • Assist in the development of document templates, relevant Standard Operating Procedures (SOPs) and guidelines.
  • Work closely with clinical personnel and the Principal Investigator to ensure that clinical documents are produced to the standard required by Good Clinical Practice (GCP).
  • Ensure accurate and complete documentation of all clinic study source documents and/or forms according to company’s SOP, GCP and other applicable guidelines.
  • Conduct all work in compliance with SOP’s, GCP and to observe all regulatory guidelines.
  • Negotiate timelines with external departments.
  • Compile study documents, as required.
  • Photocopy and scan study documents.
  • Perform other work as assigned.
Qualifications
  • Minimum university degree, B.Sc. (i.e. Life Sciences)
  • At least 2 years of Medical Writing experience
  • Experience in an CRO environment, preferably in the conduct of Phase I and Bioequivalence studies
  • Good interpersonal and communication skills
  • Attentive to details, good initiative and able to work with changing priorities
Application Process
Apply on LinkedIn

 

Toronto, Ontario - Project Manager
Job title
Toronto, Ontario – Project Manager
Position Summary
To oversee all associated activities related to a Phase I/BE study program from inception (i.e. Study award) to completion (i.e. issuance of final report).  Maintain awareness of overall study requirements in accordance with finalized protocol and ensure this is adhered to in all projects managed under your responsibility.
Duties and Responsibilities
  • Maintain a tracking process for the studies managed; including initiation, tracking, timelines reporting, budgeting and report writing
  • Within scope of position, provide sound scientific advice to clients either directly or via other BPSI staff; co-ordinate teleconferences with appropriate personnel, address client questions, concerns or comments
  • Negotiate client’s milestones and assist staff as required
  • Use appropriate communication tools to update clients on the status of their project(s); should there be any deviation, immediately handle them appropriately and if required notify Director, Project Management and/or Operations
  • Actively participate in the weekly tracking meeting making sure you are current with the most current information from operations and provide any new client information
  • Create and develop quotations for review by DPM and receive appropriate signatures as required
  • Follow up with existing accounts on new business opportunities and manage activities around outstanding quotations, Confidentiality Agreements, Contracts etc.
  • Whenever appropriate, maintain awareness and provide input on study designs and protocols
  • Assist in the preparation and maintenance of all departmental reports and all tracking databases; ensure that they are updated accurately and issued in a timeline fashion (includes quotation and contract templates, weekly tracking reports, financial reports etc.)
  • Ensure appropriate documents have been reviewed and circulated within BPSI prior to providing to clients
  • If required, assist in promotion of BPSI at industry meetings and trade shows
  • Maintain a good understanding of regulatory guidelines (TPD, FDA, EMEA, MHRA, ICH, TGA, ANVISA) and understanding of basic pharmacokinetics and statistics
  • Assist finance department in developing transfer of pertinent financial information
  • Coordinate client visits and follow up on requested documents from clients including, but not limited to, regulatory documents, study documents, validation report and brochures
  • Perform other tasks and projects as assigned
Qualifications
  • Bachelor of Science (B.Sc.) degree or equivalent
  • Relevant background in the healthcare, pharmaceutical industry
  • Minimum of 2 years experience in a project management role in either Phase I/BE or Phase I – IV setting
  • Familiarity with the management of all phase I/BE
  • Demonstrated experience dealing with a wide variety of project stakeholders at all levels in and across various organizational departments
  • Excellent interpersonal, communication and presentation skills
  • Strong organization, prioritization and problem solving skills
  • Ability to manage and handle several projects simultaneously
  • Highly proficient in MS Office Suite (Word, Excel, PowerPoint, MS Project)
Application Process
Apply on LinkedIn

 

St. Louis, Missouri - Clinical Research Recruiter
Job title
St. Louis, Missouri – Clinical Research Recruiter
Duties and Responsibilities
  • Enter and/or update potential volunteer information in the Recruitment Database
  • Offer study participation and provide tentative study information to potential study volunteers
  • Administer telephone questionnaires to potential study volunteers
  • Book, reschedule and/or cancel medical screening appointment(s) for potential study volunteer(s).
  • Perform screening reception duties as required, including but not limited to ID verification, recording of Demographic information (Medical Screening staff only).
  • Build and maintain solid relationship with study volunteers by providing excellent customer service
  • Resolve any volunteer related issues in a professional and timely manner
  • Provide metrics on advertisement, performance and recruitment activities
  • Provide statistical reports to management e.g. month end report, study recruiting stats
  • Participate in departmental meetings and assist management in implementing outlined departmental initiatives and developing strategies to maintain and increase subject retention
  • Perform any other duties as required permissible by training and experience
Qualifications
  • A minimum Grade12 high school diploma, college diploma preferred
  • 1-2 years’ experience in a customer service, call center environment
  • Strong knowledge of medical terminology an asset
  • Strong organizational, time management and planning skills to work independently with efficiency and accuracy
  • Excellent interpersonal and public relation/customer service skills
  • Strong team player with ability to multi-task in a fast-pace environment
  • Experience in dealing with and handling confidential information
  • Proficiency in English, with excellent oral and written communication skills
  • Proficiency in Microsoft Word and Microsoft Excel
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com

 

St. Louis, Missouri - Paramedic (Full Time/Part Time)
Job title
St. Louis, Missouri – Paramedic (Full Time/Part Time)
Position Summary
To monitor subject safety during confinement in compliance with the study protocols, SOPs, and regulatory requirements while fulfilling the business needs of the company.
Duties and Responsibilities
  • Perform ECG, Vital Signs, obtain blood sample and study specific testing
  • Obtain Medical History and Informed Consent from potential trial subjects
  • Explanation of the use of study drug(s)
  • Dispense and Administer study drug(s),
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event Reporting
  • Serve and/or monitor meals
  • Catheter insertion and removal
  • Perform drug/cotinine screen and alcohol test
  • Proper collecting, handling and processing of PK samples
  • Monitor and maintenance of Crash Cart
  • Cardiac Monitoring (Telemetry) (Nurse & Paramedic only)
  • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
  • Maintain accurate, complete, legible and timely data entry
Qualifications
  • Paramedic with current registration with regulatory body in Missouri.
  • Knowledge in Clinical Research and Good Clinical Practice a plus
  • Current BLS and ACLS certifications
  • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com
St. Louis, Missouri - General Manager
Job title
St. Louis, Missouri – General Manager
Position Summary

Reporting to the VP Global Clinical Operations the General Manager St. Louis Operations is responsible for the execution of the Global aspects of St. Louis trials. General Manager St. Louis Operations will be responsible for the:

  • Manage the operational aspects of clinical studies and operational expenses for the St. Louis Missouri U.S.A. Facility.
  • Meet expectations of corporate goals, timelines, cost and quality performance.
  • The General Manager St. Louis Operations will oversee the planning, development, implementation, execution, and management of assigned clinical trials, as well as participate in other areas requiring scientific/technical expertise.
Duties and Responsibilities
  • Increase management’s effectiveness by recruiting, selecting, orienting, training, coaching, counseling, and disciplining managers; communicating values, strategies, and objectives; assigning accountabilities; planning, monitoring, and appraising job results; developing incentives; developing a climate for offering information and opinions; providing educational opportunities
  • Develops strategic plan by studying technological and financial opportunities; presenting assumptions; recommending objectives.
  • Accomplishes subsidiary objectives by establishing plans, budgets, and results measurements; allocating resources; reviewing progress; making mid-course corrections.
  • Coordinates efforts by establishing procurement, production, marketing, field, and technical services policies and practices; coordinating actions with corporate staff.
  • Builds company image by collaborating with customers, government, community organizations, and employees; enforcing ethical business practices.
  • Maintains quality service by establishing and enforcing organization standards.
  • Maintains professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies.
  • Contributes to team effort by accomplishing related results as needed.
  • Ensures clinical trial activities are carried out by adhering to the policies, study protocols, SOPs, GCP and ICH requirements and pertinent regulations
  • Directs and supervises all clinical Leads and assigned staff members
  • Responsible for providing support and guidance to the various clinic teams and to coordinate all operational activities of the clinic
  • Plans, organizes, manages and monitors the clinic activities/operations in order to achieve the expected results.  Ensures that high-quality customer service is offered by all clinic employees
  • Assess performance of direct reports and other team members and establish goals and development plans with the clinic staff
  • Write SOPs, policies and rules to conduct phase 1 and bioequivalence clinical studies.
  • Participates in strategic decisions and partnering activities to increase productivity, reduce costs, and ensure that corporate clinical goals are met on time and on budget
  • Maintains current professional knowledge base of clinical research methodologies and regulatory requirements
  • Interacts with Study Monitors, investigators, regulators, vendors, and others external to the Company
  • Serves as a key interface with Project Management with regard to budget, resources, priorities, strategy, and time lines.
  • Participates on Safety Committee, Protocol Review Committee, Inter-departmental meetings
  • Actively analyze and develop action plans to address issues brought up by QA, Study Monitors, sponsors and regulatory agencies
  • Performs other tasks and projects as assigned
Qualifications
  • Nine or more years’ experience in clinical trials, five years in a management role and at least 4 years of relevant experience in a Clinical Research Organization
  • Significant experience managing Phase I-IIb, Bioavailability and Bioequivalence studies
  • Degree in Health Sciences or related discipline
  • CCRP certification
  • Computer literacy and excellent communication skills
Application Process
Apply on LinkedIn

 

St. Louis, Missouri - Registered Nurse
Job title
St. Louis, Missouri – Registered Nurse
Position Summary
To monitor subject safety while they are in confinement, in compliance with the study protocols, SOP’s regulatory requirements and fulfill business needs of the company.
Duties and Responsibilities
  • Perform ECG, Vital Signs, obtain blood sample and study specific testing
  • Obtain Medical History and Informed Consent from potential trial subjects
  • Explanation of the use of study drug(s)
  • Dispense and Administer study drug(s),
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event Reporting
  • Catheter insertion and removal
  • Perform drug/cotinine screen and alcohol test
  • Serve and/or monitor meals
  • Obtain body measurements including height and body weight, and calculate Body Mass Index (BMI).
  • Monitor and maintenance of Crash Cart
  • Cardiac Monitoring (Telemetry) (Nurse & Paramedic only)
  • Perform Advanced Medical Directives in case of emergency as per Principal Investigator or Sub-Investigator directives and as training and qualifications allow
  • Maintain accurate, complete, legible and timely data entry
  • Perform any other duties as required by Supervisor
Qualifications
  • Registered Nurse with current registration with regulatory body in Missouri.
  • Working experience in Clinical Research setting preferred
  • Working knowledge of Good Clinical Practice preferred
  • Current BCLS/ ACLS & First Aid certification.
  • Skills: Good interpersonal skills, good communication skills. Attentive to details, good initiative and able to work with changing priorities. Computer skills an asset.
  • Ability to accommodate a flexible work schedule
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com
St. Louis, Missouri - Clinical Research Technician
Job title
St. Louis, Missouri – Clinical Research Technician
Position Summary
Responsible for collecting and processing blood samples from subjects as well as supporting the screening of subjects and ongoing compliance checks, collection of test specimens from subjects, assisting Nursing staff in obtaining Vital Signs, Height/Weight, Body Mass Index (BMI) and ECG data, and other activities in support of subject monitoring. Activities will also include processing of blood samples in a laboratory setting and assistance with preparing them for shipment. In addition, will serve meals and assist in keeping the Clinic clean. These activities require that the CRT read, understand, and train to the study protocol provided.
Duties and Responsibilities
  • Review study protocol and participate in the protocol training meeting prior to performing any study related activities.
  • Perform ECG and Vital Signs
  • Collect/process blood and urine samples as well as other specimens as required.
  • Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
  • Obtain body measurements, including height and body weight, and calculate Body Mass Index (BMI).
  • Proper collecting, handling, and processing of PK samples
  • Process and ship lab samples
  • Assist in drug administration by performing hand and mouth check
  • Serve and/or monitor meals
  • Maintain accurate, complete, legible and timely data entry
  • Perform screening reception duties as required, including but not limited to ID verification, recording of demographic information
  • Perform data review of the source and/or other related documents as required.
  • Perform any other duties as required by Group Leader, Manager, Designee
Qualifications
  • CPR & First Aid certification preferred
  • Phlebotomy certification preferred
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements
Application Process
Apply on LinkedIn
St. Louis, Missouri - Lab Coordinator
Job title
St. Louis, Missouri – Lab Coordinator
Position Summary
The Lab Coordinator is responsible for providing support, guidance and training to the clinical research technician’s team and to coordinate operational activities of a study within the department. The Lab Coordinator leads a team of clinical technical support staff and is responsible for all activities related to direct supervision of staff.
Duties and Responsibilities
  • Oversees the execution of clinical trials
  • Provide input to the clinic calendar
  • Review scheduling of Clinical Research Technicians
  • Responsible for monitoring of study activitiesCoordinate all study activities to ensure protocol and regulatory requirement(s) are being met. (e.g. sample collection, sample processing, clinic set-up, etc.)
  • Provide protocol training for clinical research staff
  • Perform ECG, Vital Signs, Collect Routine Safety Labs
  • Complete compliance check on subjects
  • Proper collection, handling and processing of Pharmacokinetic (PK) sample(s)
  • Assist in drug administration verification
  • Maintain study files for each clinical trial and completion of Case Report Forms
  • Write, review and/or approve source documentation forms
  • Appropriate control, inventory, storage and record keeping of study drug(s)
  • Write and revise SOPs, internal procedures and ensure the accuracy of the generated data  in accordance with protocols, ICH, GCP and applicable regulatory agencies
  • Coordinate, Receive, Ship study supplies and/or samples
  • Maintain adequate, accurate, complete and legible records
  • Perform other tasks/duties as assigned by Supervisor
Qualifications
  • Completion of recognized Phlebotomy/ECG program
  • Medical Technologist Certification and CPR certification is preferred
  • Knowledge of good clinical practice
  • At least 2 years experience in clinical research or relevant field
  • Computer literacy: Microsoft Office. Good communication skills, problem solving, organizational and leadership skills
  • Relevant previous supervisory and training experience required
Application Process
Apply on LinkedIn
St. Louis, Missouri - Pharmacist
Job title
St. Louis, Missouri – Pharmacist
Position Summary
Responsible for the overall operation of the Pharmacy including appropriate control, inventory, storage and record keeping of study drugs, dispensing and reconciliation of study drugs and proper disposal and/or return to sponsor of the study drugs, maintain adequate, accurate, complete and legible records, write and revise SOPs in accordance with GCP/ICH, FDA.
Duties and Responsibilities
  • Review the study protocol for specific study requirements prior to the preparation of pharmacy document and drug dispensing.
  • Receive, prepare and retain study drugs according to study protocol, sponsor and/or applicable Standard Operating Procedures.
  • Request the randomization scheme from Biostatistician/Biostatistics staff. Maintain the hardcopy of the randomization scheme and follow the blinding procedures outlined in the SOPs.
  • Interact with Project Management team in regards to the study drug shipment, discrepancies and drug retentions.
  • Responsible in training staff members in assist of drug dispensing and reconciliation.
  • Establish and maintain policies and procedures regarding drug preparation and distribution according to GCP and company SOPs.
  • Ensure timely, accurate and organized completion of assigned tasks within the Pharmacy.
  • Maintain restriction to Pharmacy area.
  • Write and/or revise SOPs as required in accordance to the GCP/ICH.
  • Facilitate pharmacy tour/orientation where required.
  • Maintaining all pharmacy equipment and adequate, accurate, complete and legible records.
  • Arrange for disposal/destruction of expired drugs and retention study drugs.
  • Participate in clinical meetings and training sessions as required.
  • Provide reports to upper management as required.
  • Execute other duties as assigned.
Qualifications
  • Drug Enforcement Administration (DEA) License
  • Graduates of Pharm.D. degree programs from accredited institution.
  • Successfully passed the North American Pharmacist Licensure Examination administered by the National Association of Boards of Pharmacy (NABP)
  • Experience with controlled drug substance
  • Excellent verbal and written English Communication skills.
  • Excellent interpersonal skills.
  • Ability to work both independently and as a team member.
  • Flexible in changing shifts or hours as required by study schedule.
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to: resumes@biopharmaservices.com
What are early phase clinical trials?

Clinical Trials are divided into 4 phases.  Phase 1 and 2 trials constitute early phase trials, Phase 3 and 4 research studies are late-phase trials.

The primary objective of Phase 1 studies is to determine the correct drug dosage by evaluating drug safety and determining if there are any side effects.  Phase 1 trials are conducted in healthy volunteers.

Phase 2 studies also study the safety of a drug but focus on evaluating its effectiveness. These studies can be conducted in healthy volunteers or in individuals who have a certain disease or condition.

What is a clinical trial?

A Clinical trial is a process which is performed to determine whether an investigational drug, device or therapy is safe and effective.   In early phase research (i.e. Phases 1 and 2), the safety and effectiveness of the drug will be evaluated in healthy volunteers.

What is an investigational drug?

An investigational drug can also be called an experimental drug and is being studied to see if your disease or medical condition improves while taking it. Scientists are trying to prove in clinical trials:

  • If the drug is safe and effective.
  • How the drug might be used in that disease.
  • How much of the drug is needed.
  • Information about the potential benefits and risks of taking the drug.
Why do you need to take blood draws and how many blood draws will be required?

In order to evaluate the drug profile, we need to understand its pharmacokinetics. This is essentially how the body reacts to a drug after its administration through the mechanisms of absorption, distribution, as well as the metabolic changes. Therefore, blood draws are collected at various time points to better understand this mechanism. Each study requires a specific number of blood draws and total blood volume. These values will be provided to you and clearly stipulated in the informed consent form (ICF). The amount of blood that will be taken is outlined in the ICF.

Should I expect to experience any side-effects while doing studies?

As every study is testing an investigational product, there may be side effects. You will be provided with a list of side effects that have been reported in previous trials (if any), so you can make an informed decision whether or not to participate in the trial. During the trial you will be required to immediately inform clinic study staff of any adverse effects that you are experiencing. These side effects usually resolve upon discontinuation of the study drug.

Will I be compensated for doing a clinical study?

Volunteers are compensated and the amount varies depending on the length of the clinical trial, length of stay and number of follow-up visits. The compensation is not specifically related to the risks or type of drug involved in the trials or studies. Every study is different and therefore, the compensation will vary. Study volunteers may receive between $1000 to $4000 for a trial (based on the factors listed above).

Are food and accommodation provided over the course of the trial?

Food – Clinical trials are conducted in a controlled setting which means that all food is provided and  trial volunteers receive standardised meals.  Individual meal plans or meal preferences cannot be provided.  If you have any food allergies or hypersensitivity to food product(s) that are clinically significant or life-threatening you may not be able to participate in a trial.    Please contact us to discuss any food issues.

Accommodation – During your in-clinic stay you will share sleeping areas with other volunteers who are of the same gender.  Similar to a hospital setting, supervision will be provided to ensure that your health and safety are being monitored.

What is the length of a study and do I have to complete all the visits?

Details of the duration of a study can be found on the Volunteer Hub.

What is informed consent and how is it carried out?

Before you decide whether or not to take part in a clinical research study, you will be required to read and understand the information provided in an Informed Consent Form (ICF).  The ICF describes the clinical research study and the nature of the investigational product to be used, including:

  • Your rights and responsibilities as a study participant.
  • What you will be asked to do during study participation.
  • The potential risks that you should be aware of.

During this process, you will have the opportunity to discuss and ask questions related to the conduct of the clinical research study with the study doctor/ study staff.  You are under no obligation to participate and your decision to take part in a clinical trial is voluntary.

Can I bring my own food?

All aspects of clinical trials are closely monitored including the food and drink consumed by participants. While you are in the clinic, you will be provided with all meals as per the study guidelines. You will need to eat all the food provided to ensure the guidelines are met. Watch video

When do I receive compensation for taking part in a study?

You will receive compensation as outlined during the Informed Consent process. Typically, you will receive compensation once all study visits have been completed. If, for any reason, you do not complete all study visits, your compensation will be on a pro-rated basis (i.e. for the time that you have participated in the trial)

Where will I sleep during the clinical study?

We provide a clean, safe socially distance sleeping environment, in a dormitory of hotel room style. Watch video

What COVID-19 precautions are you taking?

The safety of our volunteers is a top priority. Learn more about the measures we are taking to create a safe environment for you.

Can I bring my own device?

Yes, we encourage you to bring items that will help to pass the time while you are in the clinic. You can use the time to study or work or catch up on the movies you’ve been meaning to watch.

Privacy

We respect and value the privacy of our volunteers. View our Privacy and Cookie Policy here.