Clinical Study Coordinator

2 weeks ago

Ontario, Canada Pharma Medica Research Inc. Full time

Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trials in healthy volunteers, special and patient populations. We're currently searching for a Study Coordinator I to join our growing team

The function of the Study Coordinator I is to plan the study activities under the supervision of the Study Coordinator II. Assist, and when necessary, supervise and/or perform all technical functions, required to generate data in compliance with protocols, Pharma Medica Research Inc (PMRI) SOP, GCP and other regulatory guidelines. Be aware at all times of human safety factors. Ensure that procedures are performed in a timely manner. Answer technical questions from technicians. Monitor Adverse Events. Assist in the supervision and direction of technical staff on study in terms of performance of functions. This position reports to Manager, Clinical Operations and/or designate.

Duties and Responsibilities
Responsibilities include but are not limited to:
1. Plan and supervise the timely execution of studies under the supervision of the Study Coordinator II.

2. Generate study summary based on the protocol.

3. Ensure that regulatory documents like FDF, FDA 1572, QIU, ERB Letter of Approval, NOL, etc. are available prior to study check-in.

4. Coordinate the ordering of study-specific materials to conduct clinical studies.

5. Conduct pre-study protocol review meetings for the technical team.

6. Ensure that the study schedule is prepared in compliance with the study requirements.

7. Communicate with the Study Preparation Coordinator and the QC Unit to ensure that appropriate CRFs are prepared prior to study check-in.

8. Liaise with the Screening Department to ensure that queries pending at check-in are addressed prior to drug administration.

9. Ensure that the study drugs are received prior to study conduction.

10. Communicate with the Principal Investigator to ensure that an Investigator is present to perform the necessary physical examination and monitoring procedures.

11. Ensure that the ICF is provided to the subjects, answer any questions the subjects may have regarding the protocol and Informed Consent, and sign the Informed Consent forms.

12. Supervise and when required, assist and/or perform all technical functions: phlebotomy, ECG, vital signs and other clinical tasks to generate data in compliance with protocol, SOP’s and GCP.

13. Performing safety-related procedures as required (e.g. conducting, vital signs, electrocardiograms, concomitant medication administration) and health monitoring.

14. Assist or administer certain types of investigational products as required for the conduct of a clinical study under the supervision/order of the investigator.

15. Ensure subject safety by timely documenting and follow-up on Adverse Events.

16. Ensure all study documentation is accurate, current, and complete according to study protocol, SOPs, GCP, and other regulatory guidelines.

17. Coordinate with Project Management department regarding study related issues and project deadlines.

18. Assist in resolving conflicts among subjects and address subjects’ concerns.

19. Generate client update and forward to Project Management department as required.

20. Coordinate with the accounting department regarding the study subject's compensation.

21. Ensure the timely shipping of the clinical and analytical samples.

22. Assist in performing final review of study documentation, ensuring accuracy according to protocol, SOPs and GCP, and other regulatory guidelines.

23. Ensure timely completion of deviation forms as needed.

24. Ensure timely receipt and review of post-study laboratory reports.

25. Ensure timely completion of the study files according to project deadlines.

26. Address queries and audit findings from QC unit and QA’s.

27. Coordinate transcription of raw data onto CRFs where necessary.

28. Update the subjects’ files for outstanding follow-ups, subjects’ behavior issues, non-compliance, etc.

29. Other duties as required.

Job Knowledge

Minimum level of academic or formalized training:

• B.Sc. degree with 1 year experience in conducting clinical trials or
• M.Sc. degree with adequate knowledge of conducting clinical trials

Minimum amount of practical work experience:

• Working knowledge of Phase I study protocols and conduct
• Understanding of the value and necessity of training and SOP’s relating to study conduct
• GCP training
• Excellent Computer Skills

Apply today if you think you are a good fit for this role

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