Assistant Screening Coordinator

2 weeks ago

Scarborough, Canada Pharma Medica Research Inc. Full time

Pharma Medica Research Inc. is a full-service contract research organization in need of an Assistant Screening Coordinator to join our team in Scarborough

The function of the Assistant Screening Coordinator is to assist in the planning for clinical studies. Perform all technical functions necessary to generate data in compliance with protocol, SOP's and GCP's at Pharma Medica Research Inc. (**_PMRI_**). 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. This position reports to Supervisor, Screening.

**Duties and Responsibilities**
Responsibilities include but are not limited to:
1. Assist in 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.

2. 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.

3. Assist in coordinate transcription of raw data onto CRFs where necessary.

6. Train screening MLA's.

7. Ensure the preparation of screening documents and necessary laboratory supplies and equipment are available for each clinic study session.

9. Ensure all screening repeat laboratory results are followed up and resolved according to PI's direction and prepared for approval.

14. Assist and ensure procurement and/or processing of biological samples as required to conduct a clinical study.

15. Assist Screening Coordinator with all study scripts and study schedules to be approved by the Manager, Screening.

16. Assist with responses to Quality Control (QC)/ Quality Assurance (QA) findings.

18. 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.

19. Ensure Joint Health and Safety rules and regulations are adhered to at all times.

20. Provide daily and weekly reports of department activities to Manager, Screening.

21. Perform any tasks required by the Manager, Screening deemed necessary to conduct a clinical study.

22. Other duties as required.

**Job Knowledge**

**Minimum level of academic or formalized training**:
Minimum B.Sc. degree with 1 year Phase I clinic experience or 2-3 years related experience within a Phase I clinical center.

**Minimum amount of practical work experience**:
2-3 years recent Canadian CRO Phase I experience or equivalent.

**Other Requirements**
- 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

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