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OUR CURRENT CAREER OPPORTUNITIES

Want to be inspired?

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

With an emphasis on personal growth and development, BioPharma Services strives to create an environment where our people matter.  To provide excellence by inspiring enhanced performance to advance medical research and creating a team to drive results.  We take pride in the work we do and welcome all individuals that want to join our dynamic culture and be a part of our brand.

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

Toronto, Ontario - Clinical Research Study Manager (CRSM-TO)

Position Summary: Oversee conduct of clinical research studies at BioPharma Services Inc. ensuring compliance with study protocol, SOPs, GCPs and regulatory requirements as well as adherence to the assigned timelines. Lead and coach Clinical Research Coordinators and Clinical Research Assistants to ensure proper planning, organization and execution of clinical research studies. Coordinate and mange Phase I studies in accordance with the protocol, SOPs, GCP guidelines, and applicable regulations, providing guidance and directions to clinic staff.

Duties and Responsibilities: Responsible for the preparation, co-ordination, monitoring and supervision of all study activities to ensure proper execution of clinical research trials (BE, Phase I, etc.)  This includes study planning, study records preparation, monitoring of subjects and clinical staff activities, and collecting and summarizing study data.  Supports management in overseeing Clinical Trials conducted and through report review.  Participates on cross divisional teams providing clinical expertise and guidance.

Key Job Responsibilities
  • Reviews protocol pre-study for accuracy, compliance, safety and feasibility of study design
  • Interacts with other clinical staff to plan the logistics of study execution
  • Interacts with SPA/CRC/CRCa/RA/QC to ensure timely completion of pre-study documentation and clinical reports
  • Reviews subject and study documentation, CRFs and source documents
  • Monitors clinical activities during the conduct of the clinical trials
  • Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required
  • Participates in the verification and administration of the study drug
  • Oversees the sample transfer/shipment process
  • Reviews, compiles and summarizes clinical data
  • Conducts peer review of clinical study documentation; pre-clinic and post-clinic
  • Ensures projects meet the projected timelines and communicates updates to management and other project team members
  • Evaluates eligibility of volunteers and enrols acceptable volunteers into studies
  • Directly supervises and takes delegated responsibility for the conduct and safety of subjects participating in clinical trials, for adherence to protocols and regulatory requirements
  • Utilizes clinical knowledge to support BPSI in the preparation and execution of more complex clinical trials
Relationship with Internal/External Customers & Stakeholders 
  • Participates and contributes as a team leader or co-leader of a BPSI Team in planning and executing study projects and provide update study reports.
  • Interacts with personnel from other departments within BPSI to discuss project timelines and problem solve any issues that arise
  • Communicates study requirements and study progress with colleagues and management
  • Develops and maintains a working relationship with members of other departments.
  • Communicates study requirements to subjects
  • Interacts with subjects in a respectful, professional and courteous manner in the performance of day to day activities
  • Co-operates with and supports the activity of Sponsor Monitors/ Auditors/Inspectors
  • Collaborates with QC and QA during audits and audit Follow-ups. Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
Problem Solving Analysis
  • Utilises advanced problem-solving techniques to identify root causes of operational problems/issues and determines the best course of action.
  • Investigates and recommends, the usage of new or unconventional problem solving research techniques to the department
  • In consultation with management, develops strategies to address study logistical issues during study preparation.
  • Resolves complex issues with internal/external customers
  • Responds to regulatory agencies to deficiencies in consultation with management
Decision Making/Autonomy 
  • Demonstrates the ability to make complex interpretation and application decisions within role capacity by utilizing protocol, Standard Operating Procedures and Departmental Practices
  • Reviews issues presented by Sponsor in the conduct of clinical trials and makes recommendations in consultation with management.
  • 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
Leadership/Professional Development of Self & Others 
  • Monitors and provides feedback to clinic staff regarding their performance on an ongoing basis.
  • Provides management with regular updates concerning staff performance.
  • Provides leadership and guidance to CRC and CRCa
  • Assists in training Clinical Research/Operations staff
  • Completes required training within targeted timelines, initiates professional developmental plan and maintains personal training records.
  • Stay current on changing regulatory and GCP trends, policies and practices as they pertain to the conduct of Clinical studies 
Compliance & Due Diligence 
  • Conducts duties following established BPSI Standard Operating Procedures and departmental practices and directives in a manner consistent with appropriate regulatory guidelines, GCP requirements and Safe Work Procedures
  • Assists in the creation, development and revision of BPSI Standard Operating Procedures and departmental practices
  • Ensures that clinical staff complete deviation exercises and investigates and implements actions to prevent reoccurrence of deviations by following up with clinical staff
Other Responsibilities: 
  • Demonstrates corporate values and supports divisional objectives in the performance of work and in interactions with others
  • Executes other duties as may be assigned by management as training and experience allow
Qualifications:
  • Completed post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
  • Certification in Clinical Research is an asset
  • Flexible hours depending on business requirements
  • 3+ years’ work experience in a CRO (preferably in conducting Phase 1/Bioequivalence clinical trials)
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Excellent in Microsoft Word and Excel
Salary Range - $50,000 to $100,000.
Relocation Assistance
Comprehensive Group Benefits Program
Group RRSP Program
Please send your application to resumes@biopharmaservices.com

Toronto, Ontario - Senior Leader Phase 1

Position Summary:
Responsible for the operational conduct of clinical trials to ensure clinical trial execution is in accordance with study protocols, SOP’s, GCPs and regulatory requirements.
This role is responsible for the planning, development, implementation, execution, and management of clinical trials which are in alignment with our corporate objectives.

Qualifications would include:
Degree in Health Sciences or related discipline (MD or RN preferred)
Minimum ten years’ experience in clinical research
Five+ years’ experience in a management role and at least
Four+ years of relevant experience in a CRO environment managing Phase I-II Bioavailability and Bioequivalence studies

Relocation Assistance
Eligible to work in Canada
Comprehensive Group Benefits Program
Group RRSP Program
Job Type: Full-time
Salary: $100,000.00 to $140,000.00

Please send your application to resumes@biopharmaservices.com

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
        Please send your application to resumes@biopharmaservices.com

Toronto, Ontario - Records Administrator

Duties and Responsibilities:
  • Perform to company SOP requirements/guidelines and Good Clinical Practices.
  • Compile study documents.
  • Ensure accurate and complete documentation of all clinic study source documents, case report forms (CRF) and/or forms according to company’s SOP, GCP and other guidelines.
  • Photocopy and scan study documents and CRF.
  • Assist with archiving duties.
  • Order Medical Writing supplies when necessary.
  • Perform other duties as required.
  Qualifications:
  • Minimum 1 years of pharmaceutical or clinical experience
  • Experience in CRO environment preferably in conduct of Phase I and Bioequivalence studies
  • Good interpersonal skills, good communication skills.
  • Attentive to details, good initiative and able to work with changing priorities.
  Please send your application to resumes@biopharmaservices.com

Toronto, Ontario – Facility Cleaner

Shift Flexibility:
    Mornings 6:00am-2:00pm / Afternoons 14:00-22:00 / Night Shift 22:00-6:00 / Weekends.
Position Summary:
    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
  •   Please send your resume to resumes@biopharmaservices.com

Columbia, Missouri - Clinical Research Study Manager (CRSM-MO)

Position Summary: Oversee conduct of clinical research studies at BioPharma Services USA Inc. ensuring compliance with study protocol, SOPs, GCPs and regulatory requirements as well as adherence to the assigned timelines. Lead and coach Clinical Research Coordinators and Clinical Research Assistants to ensure proper planning, organization and execution of clinical research studies. Coordinate and mange Phase I studies in accordance with the protocol, SOPs, GCP guidelines, and applicable regulations, providing guidance and directions to clinic staff.

Duties and Responsibilities: Responsible for the preparation, co-ordination, monitoring and supervision of all study activities to ensure proper execution of clinical research trials (BE, Phase I, etc.)  This includes study planning, study records preparation, monitoring of subjects and clinical staff activities, and collecting and summarizing study data.  Supports management in overseeing Clinical Trials conducted and through report review.  Participates on cross divisional teams providing clinical expertise and guidance.

Key Job Responsibilities
  • Reviews protocol pre-study for accuracy, compliance, safety and feasibility of study design
  • Interacts with other clinical staff to plan the logistics of study execution
  • Interacts with SPA/CRC/CRCa/RA/QC to ensure timely completion of pre-study documentation and clinical reports
  • Reviews subject and study documentation, CRFs and source documents
  • Monitors clinical activities during the conduct of the clinical trials
  • Assists with dispensing, appropriate control, inventory, storage and record keeping of study drug(s) as required
  • Participates in the verification and administration of the study drug
  • Oversees the sample transfer/shipment process
  • Reviews, compiles and summarizes clinical data
  • Conducts peer review of clinical study documentation; pre-clinic and post-clinic
  • Ensures projects meet the projected timelines and communicates updates to management and other project team members
  • Evaluates eligibility of volunteers and enrols acceptable volunteers into studies
  • Directly supervises and takes delegated responsibility for the conduct and safety of subjects participating in clinical trials, for adherence to protocols and regulatory requirements
  • Utilizes clinical knowledge to support BPSI in the preparation and execution of more complex clinical trials
Relationship with Internal/External Customers & Stakeholders 
  • Participates and contributes as a team leader or co-leader of a BPSI Team in planning and executing study projects and provide update study reports.
  • Interacts with personnel from other departments within BPSI to discuss project timelines and problem solve any issues that arise
  • Communicates study requirements and study progress with colleagues and management
  • Develops and maintains a working relationship with members of other departments.
  • Communicates study requirements to subjects
  • Interacts with subjects in a respectful, professional and courteous manner in the performance of day to day activities
  • Co-operates with and supports the activity of Sponsor Monitors/ Auditors/Inspectors
  • Collaborates with QC and QA during audits and audit Follow-ups. Maintains current professional knowledge base of clinical research methodologies and regulatory requirements (FDA, TPD, etc.)
Problem Solving Analysis
  • Utilises advanced problem-solving techniques to identify root causes of operational problems/issues and determines the best course of action.
  • Investigates and recommends, the usage of new or unconventional problem solving research techniques to the department
  • In consultation with management, develops strategies to address study logistical issues during study preparation.
  • Resolves complex issues with internal/external customers
  • Responds to regulatory agencies to deficiencies in consultation with management
Decision Making/Autonomy 
  • Demonstrates the ability to make complex interpretation and application decisions within role capacity by utilizing protocol, Standard Operating Procedures and Departmental Practices
  • Reviews issues presented by Sponsor in the conduct of clinical trials and makes recommendations in consultation with management.
  • 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
Leadership/Professional Development of Self & Others 
  • Monitors and provides feedback to clinic staff regarding their performance on an ongoing basis.
  • Provides management with regular updates concerning staff performance.
  • Provides leadership and guidance to CRC and CRCa
  • Assists in training Clinical Research/Operations staff
  • Completes required training within targeted timelines, initiates professional developmental plan and maintains personal training records.
  • Stay current on changing regulatory and GCP trends, policies and practices as they pertain to the conduct of Clinical studies 
Compliance & Due Diligence 
  • Conducts duties following established BPSI Standard Operating Procedures and departmental practices and directives in a manner consistent with appropriate regulatory guidelines, GCP requirements and Safe Work Procedures
  • Assists in the creation, development and revision of BPSI Standard Operating Procedures and departmental practices
  • Ensures that clinical staff complete deviation exercises and investigates and implements actions to prevent reoccurrence of deviations by following up with clinical staff
Other Responsibilities: 
  • Demonstrates corporate values and supports divisional objectives in the performance of work and in interactions with others
  • Executes other duties as may be assigned by management as training and experience allow
Qualifications:
  • Completed post-secondary degree in a science or healthcare related discipline, or equivalent work experience.
  • Certification in Clinical Research is an asset
  • Flexible hours depending on business requirements
  • 3+ years’ work experience in a CRO (preferably in conducting Phase 1/Bioequivalence clinical trials)
  • Excellent problem solving, communication, multitasking and interpersonal skills
  • Excellent in Microsoft Word and Excel
 Salary Range - $50,000 to $100,000.
 Relocation Assistance
Comprehensive Group Benefits Program
401K Retirement Plan
Please send your application to resumes@biopharmaservices.com

Columbia, Missouri – Supervisor, Clinical Research Recruiting

Position Summary:

The Supervisor, Recruiting Department is responsible for providing support, guidance and training to the Recruiting team and to coordinate operational activities of a study within the department. The Supervisor leads a team of technical support and recruiting staff and is responsible for all activities related to direct supervision of staff.

Duties and Responsibilities:

  • Preparation of Study Master List
  • Liaise with Director and operatives to gather information and plan efficient study deployment.
  • Maintained up-to-date knowledge of study information and study planning strategies.
  • Supervised the tasks of Clinical Contact Centre Representatives including acknowledgement of Study Briefings, updating the clinical database, responding to inbound calls and booking appointments.
  • Organize, oversee and conduct clinical staff training, performance reviews and coaching.
  • Write, Revise, and approve SOP’s and internal procedures.
  • Participates in protocol review and development.
  • Coordinate all recruiting activities to ensure that all protocol, SOP, GCP and regulatory requirement(s) are met.
  • Generate recruitment highlights (protocol summary).
  • Conduct protocol training for all Recruiting staff.
  • Enter/update potential volunteer information in the Recruitment Database.
  • Offer study participation / provide tentative study information to potential volunteers.
  • Participates in protocol review process.
  • Administer telephone questionnaires to potential volunteers.
  • Book/reschedule/cancel medical screening appointment for potential volunteers.
  • Informing potential subjects of their medical screening results.
  • Assigning tentative subject numbers.
  • Update subject study history in the Recruitment Database.
  • Performs other tasks and projects as assigned.
Qualifications:
  • Knowledge of Good Clinical Practice
  • Able to work in a research setting and aware of the confidentiality that is required in research
  • At least 2 years experience in clinical research or related field
  • Computer literacy: MS Office, good communication skills, problem solving, organizational and leadership skills
  • Relevant previous supervisory and training experience required
Please send your application to resumes@biopharmaservices.com

Columbia, Missouri - Phase 1 -Principal Investigator

Position Summary: Principal Investigator will be responsible for promoting Good Clinical Practice (GCP) in the conduct of Phase 1 clinical investigations by ensuring adherence to protocol requirements, protecting the rights and welfare of subjects, assuring the integrity of the data generated and directing the conduct of the clinical investigation according to government regulations and guidance documents.

Duties and Responsibilities:
  • Provides Investigator Qualifications and agreements
    • Maintaining a current, up-to-date curriculum vitae
    • Maintaining a current license to practice
    • Demonstrating proper education, training and experience to conduct a clinical investigation
    • Assuming responsibility for the conduct of the clinical investigation
    • Signing all required regulatory documents
    • Disclosing financial disclosure/interest as described by regulations
  • Ensuring Protocol Compliance
    • Possessing a thorough understanding of the requirements of each protocol
    • Determining that the inclusion/exclusion criteria are applicable to the study population
    • Following the trial’s randomization procedures
  • Ensures Initial and Ongoing Review by an IRB
    • Providing the IRB with adequate information to initially review the study
    • Providing the IRB with documents for ongoing review (e.g., protocol amendments, adverse events)
    • Securing written IRB approval prior to initiating a study or instituting any changes to the protocol as approved
  • Determines adequate resources are available to conduct the study
    • Having adequate number of qualified staff to conduct the study
    • Having adequate facilities to conduct the study
    • Ensuring adequate time to conduct and supervise the study
  • Manages the medical care of subjects
    • Responsible for all trial-related medical decisions
    • Assessing subject compliance with the test article and follow-up visits, Evaluating medical history, lab results, vital signs and ECGs
    • Conducting physical examinations
    • Evaluating adverse events
    • Ensuring that medical care is provided to a subject for any adverse event(s)
  • Informing a subject when medical care is needed to treat an intercurrent
  • illness(s)
  • Protects the rights and welfare of subjects
    • Reporting all serious adverse events immediately to the sponsor and IRB
    • Ensuring that the informed consent form contains all the elements required by GCP
    • Obtaining a signed and dated informed consent from each subject prior to initiating any study-related procedures
  • Informing the subject or legal representative about all aspects of the Clinical trial
  • Providing new information about the study
  • Ensures validity of the data reported to the sponsor
    • Ensuring the accuracy, completeness, legibility and timeliness of case report forms
    • Explaining any discrepancies or corrections on case report forms
  • Ensures documentation of study-related procedures, processes and events
    • Documenting deviations from the approved protocol
    • Documenting and explaining premature unblinding of the investigational product
  • Documenting that informed consent has been obtained from the subject
  • Ascertaining the reason for a patient’s premature study withdrawal
  • Documenting adverse events
  • Providing study reports as requested by the sponsor, IRB and regulatory authorities
  • Ensures the proper use and storage of investigational products
    • Being thoroughly familiar with the use of the investigational product(s)
    • Reading the current investigator’s brochure, product insert or other source information
    • Assuming responsibility for the investigational product at the trial site
    • Ensuring the proper use and storage of the investigational product(s) at the trial site
    • Reviewing the proper use of the study articles by the subjects
  • Direct Site Operations
    • Delegating authority and maintaining a delegation of authority list
    • Making available to monitors, auditors, IRB and regulatory authorities all requested trial-related records
    • Ensuring that all staff are informed about their trial related duties and functions
  Qualifications:
  • Current license with no restrictions
  • Current ACLS certification is preferred
  • Current DEA license
  • Able to work in a research setting and aware of the confidentiality that is required in research
  • Experience in Emergency Medicine, Clinical Research or related field an asset
  • Good communication skills, problem solving, organizational and leadership skills
Please send your application to resumes@biopharmaservices.com

Columbia, Missouri – Senior Leader Phase 1

Position Summary:
Responsible for the operational conduct of clinical trials to ensure clinical trial execution is in accordance with study protocols, SOP’s, GCPs and regulatory requirements.
This role is responsible for the planning, development, implementation, execution, and management of clinical trials which are in alignment with our corporate objectives.

Qualifications would include:
Degree in Health Sciences or related discipline (MD or RN preferred)
Minimum ten years’ experience in clinical research
Five+ years’ experience in a management role and at least
Four+ years of relevant experience in a CRO environment managing Phase I-II Bioavailability and Bioequivalence studies

Relocation Assistance
Eligible to work in the United States
Group Benefits Program
401K Retirement Plan
Job Type: Full-time
Salary: $100,000.00 to $140,000.00

Please send your application to resumes@biopharmaservices.com

Columbia, 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 (with the exception of blood collection), 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 (if IATA certified)
  • 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 Management

Qualifications:

  • CRO experience a plus
  • CPR & First Aid certification a plus
  • Phlebotomy certification preferred
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements

Please send your resume to resumes@biopharmaservices.com

Columbia, Missouri – Clinical Assistant

Reports to:

Manager, Clinical Operations

Position Summary:

Responsible for assisting in screening of subjects and ongoing compliance checks, collection of test specimens from subjects (with the exception of blood collection), 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. Will also serve meals and assist in keeping the Clinic clean. These activities require that the CA 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.
  • Compliance check on subjects
  • Collect urine samples as well as other specimens as required.
  • Assist Nursing staff with obtaining Vital Signs, Height/Weight, Body Mass Index (BMI) and ECG
  • Perform drug/cotinine screen and alcohol test as well as urine pregnancy test.
  • Process and ship lab
  • 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
  • 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
  • International Air Transportation Association (IATA) Certification, preferred
  • Flexible hours depending on business requirements.
  • Rotating shifts and weekend requirements

Please send your resume to resumes@biopharmaservices.com

Columbia, Missouri – QC Data Reviewer

Reports to: Supervisor, Quality Control   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 the 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.
Please send your resume to resumes@biopharmaservices.com