Pharma Medica Research is a full service contract research organization specialized in conducting early phase clinical trails in healthy volunteers, special and patient populations. We are currently looking for a Screening Coordinator to join our clinic location in Scarborough.
The function of the Screening Coordinator I is to coordinate and fill the study panel through recruitment and medical screening. Perform all technical functions necessary to generate data in compliance with protocol, SOPs and GCP requirements at Pharma Medica Research Inc. (PMRI). Be aware at all times of the human safety factors. Ensure that procedures are performed in a timely manner. Answer technical questions from technicians. Monitor adverse events. This position reports to the Supervisor, Screening and/or designate.
Duties and Responsibilities
Responsibilities include but are not limited to:
Study Co-ordination
1. Supervise and/or perform all technical functions: phlebotomy (if certified), ECG, vital signs and other clinical tasks to generate data in compliance with protocol, SOPs and GCP.
2. Coordinate the ordering of study specific materials needed to conduct clinical studies.
3. Coordinate with other clinic departments to ensure study screening as per plan.
Screening
4. Complete all aspects of the screening process in compliance with protocol specific requirements, SOP, GCP, FDA, TPD or other relevant regulatory agency guidelines. Ensure proper documentation of clinical activities according to SOP, GCP, TPD, FDA or other regulatory agency guidelines.
5. Schedule screening sessions and conduct protocol meetings based on study requirements.
6. Record participants’ medical histories or adverse events during the medical screening period.
7. Ensure the preparation of screening documents and that the necessary laboratory supplies and equipment are available for each clinic study session.
8. Ensure each participant’s file is prepared and completed with all the necessary documents including laboratory results for review by the Investigators.
9. Ensure all screening repeat laboratory results are followed up and resolved according to the Investigators’ direction and prepared for approval.
10. Follow up with the PI to ensure that any communicable disease results are provided to the participant’s physician for necessary follow-up.
11. Ensure participant demographics obtained at recruitment are consistent with information obtained at medical screening.
12. Provide the Supervisor, Screening with a qualifying panel of participants for each clinical study.
13. Ensure the participant database is updated as required by the screening activities.
14. Maintain on-site hard copy files of screening results on all participants.
15. Supervise and ensure the procurement and/or processing of biological samples as required to conduct a clinical study.
16. Prepare all study scripts and schedules to be approved by the Supervisor, Screening.
17. Address Quality Control (QC)/ Quality Assurance (QA) findings/reports, follow up with participant’s regarding their medical results or screening repeat tests.
18. Receive participant in-bound calls for results and assign qualifying participants with tentative numbers for clinical study entry.
19. Provide daily and weekly reports of department activities to the Supervisor, Screening.
20. Perform any tasks required by the Supervisor, Screening deemed necessary to conduct a clinical study.
21. Assist in training or coaching the screening MLAs and Medical Screeners as needed.
22. Participate regularly in all training programs and achieve 80% or greater in all PMRI training evaluations including SOP, GCP testing and PMRI in-house training modules.
23. Ensure Joint Health and Safety rules and regulations are adhered to at all times.
24. Perform any tasks required by the Manager, Screening deemed necessary to conduct a clinical study.
25. Other duties as required.
Qualifications:
- Minimum B.Sc. degree with 1 year experience in conducting clinical trials or;
- 2 years of recent CRO Phase I experience or equivalent.
- Working knowledge of Phase I study Protocols and conduct.
- GCP training.
- Excellent communication skills including excellent English verbal and written skills.
- Excellent understanding of Phase I study protocols and conduct.
- Excellent computer skills.
- Ability to communicate clearly and effectively with direct reports and other clinical staff.
- Excellent interpersonal skills.
- Ability to work both independently and as a team member.
- Exceptional organizational skills.
We Offer
- Competitive compensation plan
- Opportunities for advancement and career progression
- A generous Employee Milestones Awards Program
- Corporate Discounts Program
- Learning Support Programs
- Friendly atmosphere, culture of learning
Please note all applications must be eligible to work within Canada.
PMRI is an Equal Opportunity Employer; promoting accessibility and inclusivity at work and offering accommodation for applicants as required and requested.
We thank all applicants for their interest; however, only those selected to proceed in the interview process will be contacted.
If you meet the qualifications and are looking for an exciting place to work, apply today!