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Seeking highly motivated, innovative thinking, medical and scientific professionals.

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 - Clinical Research Recruiter
Job title
Toronto, Ontario – Clinical Research Recruiter
Position Summary
Perform telephone interview and day-to-day activities of Recruiting department.
Duties and Responsibilities
  • Conduct telephone eligibility screening of potential English-speaking volunteers for inclusion or exclusion in all phases of clinical trials which includes but is not limited to:
    • Reviewing screening criteria,
    • Providing an overview of the study,
    • Responding to volunteer preliminary questions,
    • Capturing brief medical and medication history of volunteers
    • Completion of required paperwork
  • Book appointments for potential volunteers for onsite screening and assign volunteers to studies based on the results of medical screening visits
  • Daily data entry, maintenance and updating of electronic volunteer files into Bio Pharma Services Inc. subject database for telephone recruitment
  • Track statistics for clinical trials including but not limited to fill ratio, advertisement responses, and volunteer no show rates
  • Create documents as required by recruitment and screening processes including, but not limited to:
    • Create Recruitment packages
    • Prepare lists for screening
    • Process referrals and referral payments
    • Master lists for Check-ins
  • Participate in training of new hires if experience allows
  • Involvement in departmental meetings
  • Cooperate with and support the Quality Assurance (QA) group during audit activities
  • Ensure compliance with appropriate BioPharma Services Inc. SOP’s and GCP and ICH guidelines
  • Other duties as may be required & as training and experience allow
Qualifications
  • Undergraduate degree in sciences or equivalent
  • 1 – 2 years’ experience in a customer service environment and/or call center
  • 1-year work experience in a CRO an asset
  • Previous sales experience preferred
  • Strong organizing and planning skills to work independently with efficiency and accuracy
  • Excellent interpersonal and public relation skills
  • Demonstrated proficiency in English, with excellent oral and written communications skills
  • Decisive, good decision-making skills, able to escalate response to situations when relevant
  • Proficient 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 - 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 - Clinical Data Associate
Job title
Toronto, Ontario – Clinical Data Associate
Position Summary
The Clinical Data Associate, working with senior data management members, is responsible for entering clinical study data into an electronic database(s), setup databases, data cleaning/query management and documentation of clinical study databases and clinical data for clinical studies to current regulatory and industry expectations and standards.
Duties and Responsibilities
  • Perform assigned activities related to data management per regulation and applicable standard operation procedures (SOPs)
  • Contributes to the development and testing of study specific databases and clinical study data for mainly Phase I and BA/BE clinical studies and potentially for Phase II-IV clinical studies
  • Editing, processing (data entry) and entry of data into an electronic database from relevant clinical study documentation (e.g., Case Report Forms, Source Documentation)
  • Resolution of database queries, as generated in real-time or following completion of all planned data entry
  • QC review of entered clinical trial data to ensuring accurate and precise entry of all data
  • Identifying issues and queries with study documentation and bringing this to the attention of the direct supervisor (or designate)
  • Adherence to study timelines
  • Performing all work in accordance with BSPI Standard Operating Procedures, relevant regulatory guidelines and study requirements
  • Involved in the management of the process from DMP development to data entry, data cleaning and data transfer
  • Contributes to or writes the Data Management Plan (DMP) and other data management documentation
  • Design and review eCRFs according to the study protocol, set up database, perform user acceptor testing (UAT) and lock database and study data
  • Performs quality control (QC) on study data as needed
  • Create, review, and process data queries and updates the database
  • Query data inconsistencies and revise case report forms in compliance with SOPs, client guidelines and regulatory agency guidelines
  • Other duties & responsibilities as required
Qualifications
  • Experience in data entry or Data Management activities, performing activities in relationship to setup, conduct and locking of clinical data
  • BA or BS with a science or related background; equivalent experience in data management and a medical-related field may be substituted
  • Understanding of database structures and database programming
  • Knowledge of CDISC standards, especially CDASH and SDTM
  • Knowledge of clinical trial processes and experience in, ICH GCP, and GCDMP (SCDM)
  • Proficiency in MS Windows navigation, Word, Excel, PowerPoint, and email applications
  • Strong analytical and problem solving skills
  • The ability to multi-task and prioritize are essential
  • Strong oral and written communication skills
  • Self-motivated, with the ability to learn quickly and independently
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 - Quality Assurance Auditor - Lab
Job title
Toronto, Ontario – Quality Assurance Auditor – Lab
Position Summary
The Quality Assurance Auditor is responsible for planning, conducting, and reporting quality assurance audits as scheduled. The QA Auditor supports QA Management in promoting and assessing compliance of clinical and non-clinical studies with applicable regulations, guidelines, study protocols, study plans and company SOPs.
Duties and Responsibilities
  • Performs inspections of Bioanalytical GLP and Non-GLP studies, for compliance with the OECD Principles of Good Laboratory Practices, Study Plans and Standard Operating Procedures (SOPs) at the critical phases of the studies including Study Plans, In-process audits, Raw Data Audits and Analytical Report Audits and reports the observations of such inspections to the Principal Investigator(s) and Laboratory Management.
  • Performs audits of Method Validation activities including in-process audits, raw data reviews and Validation Report.
  • Conducts various facility, process and system audits, including audits of equipment maintenance, training records, archiving processes and computer validation and reports the observations of such inspections to the Laboratory Management.
  •  Performs audits of clinical trials for compliance with Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMA, etc.) including pre-study documentation, in-process activities, end-of-study documentation and clinical study reports.
  • Keeps Management up to date with findings and follow up on corrective actions.
  • Complete CTA applications and communicate with TPD as required.
  • Assists in the review, control and distribution of SOPs.
  • Assists QA management in hosting sponsor and regulatory audits/inspections.
  • Trains other QA staff on tasks/activities specified by QA management.
  • Assists QA management in the training of BPSI staff on SOPs, GCP, GLP, etc.
  • Coordinates and interacts with other departments to ensure corporate, departmental and project goals are met.
  • Performs other relevant tasks delegated by QA management.
Qualifications
  • University degree in a scientific area, or equivalent.
  • 1-2 years QA experience, preferably including audits of Phase 1 and /or BA/BE studies
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 - Physician Assistant
Job title
Toronto, Ontario – Physician Assistant
Position Summary
The Physician Assistant, under the direction and supervision of a registered Physician, and in accordance with the College of Physicians and Surgeons of Ontario’s policy on delegation, the Physician Assistant (PA) provides medical care to patients based on mutually agreed upon guidelines. 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
  • Dispense and Administer study drug(s)
  • Receive physician’s medication order and administer medications from the crash cart
  • Adverse Event AE monitoring and documentation/ Serious Adverse Event (SAE) Reporting
  • Check-in procedure
  • Assess Lab Results
  • Exercise reasonable care and caution in protecting confidential and sensitive information related to clients
  • Cardiac Monitoring (Telemetry)
  • 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
  • Performs other tasks and projects as assigned
  • Exercise reasonable care and caution in protecting confidential and sensitive information related to clients
  • Conduct screening, physical exams, review blood results, investigation on ECG’s reports,
  • Monitor subjects during and after dosing
Qualifications
  • Certified by the Physician Assistant Certification Council of Canada
  • Eligible to work in Canada/Ontario
  • Effective organizational skills, time management skills, interpersonal skills, problem-solving skills, and communication skills (both written and oral)
  • Experience in a fast-paced primary care clinic environment is an asset
  • Team player willing to roll up their sleeves and become a part of the innovative efforts the clinic is currently undergoing
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 Assistant
Job title
Toronto, Ontario – Medical Assistant
Position Summary
The Medical Assistant provides physician support services that ensure that clinic facility runs smoothly. Responsible for administrative as well as clinical tasks, such as maintaining patient records, preparing patients and rooms for examination, assisting physicians with exams, and performing front-desk tasks.
Duties and Responsibilities
  • Receive and direct phone calls, schedule appointments, check-in patients, obtain necessary patient information to file and update patient records, and ensure all forms and consents are completed by patients
  • Check-out patients, assist with referral processing, and arrange laboratory services
  • Handle billing process
  • Prepare patients for examination, take vitals, and record patients’ health history
  • Set-up EKG machines, administer injections and medications, and perform routine specimen collection and tests
  • Prepare equipment and examination rooms, and clean instruments
  • Assist physician with medical treatments, procedures, and exams
Qualifications
  • High school diploma or GED required; completion of an accredited medical assistance certification program preferred
  • Excellent interpersonal skills
  • Ability to communicate clearly and effectively with patients and other external parties in a courteous and friendly manner at all times
  • Must be detail-oriented and highly organized
  • Firm grasp on medical practices, administrative processes, and organizational policies
  • Knowledge of patient care and examination procedures
  • Must be able to maintain confidentiality at all times
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: resumesstl@biopharmaservices.com
St. Louis, Missouri - Clinical Research Coordinator
Job title
St. Louis, Missouri – Clinical Research Coordinator
Position Summary
 
Duties and Responsibilities
  • Coordinating conduct of the assigned clinical trial. This includes but is not limited to:
  • Preparation of study related documentation
  • Review and completion of study documents (Case Report Forms and Source Documents)
  • Perform clinical and study procedures as per study protocol as training and experience allows
  • Detailed review of subject and study documentation, case report form (CRFs) and source documents
  • Ensure the conduct of clinical trials according to the applicable Good Clinical Practice (GCP) guidelines, applicable regulations, Protocol and BioPharma Services Inc. Standard Operating Procedures (SOPs) at all times
  • Work with the QA group during Audits and Audit Follow-up and in the development/revision and implementation of Standard Operating for the Phase I and Bioequivalence trials; ensure that the SOPs are consistent with GCP, and regulatory guidelines; review and update SOPs as required
  • Responsible for remaining current with regulatory requirements (TPD, FDA, etc.)
  • Participate in staff training sessions
  • Other duties as may be required & as training and experience allow

 

Qualifications
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements.
  • 1-2 years work experience (preferred) in a CRO with experience in conducting Phase I /Bioequivalence clinical trials.
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Excellent in Microsoft Word and 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:  resumesstl@biopharmaservices.com
St. Louis, Missouri - Director, Clinical Operations
Job title
St. Louis, Missouri – Director, Clinical Operations
Position Summary

Reporting to the VP Global Clinical Operations the Director, Clinical Operations 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
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com

 

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:  resumesstl@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
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com
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 equipments 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.
Application Process
If you are interested or know of someone who would be interested in applying for this position, Please send your application to:  resumesstl@biopharmaservices.com
St. Louis, Missouri - QC Data Reviewer
Job title
St. Louis, Missouri – QC Data Reviewer
Position Summary
Responsible for reviewing of all study related documentation to ensure the quality, reliability, accuracy, completeness and consistency according to Protocol, SOPs and Regulatory requirements. Other responsibilities as assigned.
Duties and Responsibilities
  • Review study files after completion and ensure that they are accurate and legible according to protocol, SOPs and regulations
  • Ensure all prepared study source documents and/or forms are in accordance to protocols, SOPs and regulations
  • Review all other study related documentation: medical screening files, pharmacy labels and files, final report tabulations and PK STAT input and output as assigned
  • Observe, on a random basis, clinical procedures during the conduct of studies, sample bundling and shipping process
  • Provide reports of the reviewed data to relevant personnel/department
  • Perform other duties as assigned by supervisor
Qualifications
  • Post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
  • 1-2 years of relevant clinical research experience, knowledge of ICH-GCPs and professional experience working in CRO
  • Ability to accommodate a flexible work schedule and to adapt to changing priorities; able to work under pressure.
  • Excellent communication skills
  • Excellent computer skills
  • Certification in Clinical Research is 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:  resumesstl@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.