Screening Coordinator

3 weeks ago

Toronto, Canada Pharma Medica Research Inc. Full time

the Screening Coordinator supervises the planning for clinical studies. Supervise and/or perform all technical functions necessary to generate data in compliance with protocol, SOPs and GCP. Must be aware at all times of human safety factors, ensure that procedures are performed in a timely manner, answer technical questions from technicians and monitor adverse events. This position reports to Supervisor, Screening and/or designate.

**Duties and Responsibilities**:

- Supervise 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.
- Coordinate transcription of raw data onto CRFs where necessary.
- Coordinate ordering of study specific materials to conduct clinical studies.
- Supervise all aspects of the screening process in compliance with protocol specific requirements, SOP, GCP, FDA, TPP or other relevant regulatory agency guidelines. Ensure proper documentation of clinical activities according to SOP, GCP, TPP, FDA or other regulatory agency guidelines.
- Schedule screening sessions based on study requirements.
- Ensure the preparation of screening documents and necessary laboratory supplies and equipment are available for each clinic study session.
- Ensure all screening laboratory results are reviewed and signed by the PI.
- Ensure all screening repeat laboratory results are followed up and resolved according to PI's direction and prepared for approval.
- Supervise and ensure procurement and/or processing of biological samples as required to conduct a clinical study
- Prepare all study scripts and schedules to be approved by the Supervisor, Screening.
- Assist with responses to Quality Control (QC)/ Quality Assurance (QA) findings.
- Provide daily and weekly reports of department activities to Supervisor, Screening.
- Perform any tasks required by the Supervisor, Screening deemed necessary to conduct a clinical study.
- Other duties as required.

**Requirements**:

- Minimum B.Sc. degree with 1 year Phase I clinic experience or 2 years related experience within Phase I clinical trials. Clinical Research Coordinator designation as per ACRP guidelines
- 3-5 years recent Canadian CRO Phase I experience or equivalent.
- Excellent computer skills
- Ability to communicate clearly and effectively with direct reports and other clinical staff.
- Exceptional organizational skills

**We offer**:

- Competitive compensation plan
- Mentorship Opportunities
- A benefit plan that is fully paid for by PMRI, including healthcare, dentalcare, vision care, LTD, Life Insurance, AD&D, along with a Health Spending_ and_ Wellness Spending Accounts and a voluntary RRSP Contribution Plan
- Opportunities for advancement and career progression
- A generous Employee Milestones Awards Program
- Corporate Discounts Program
- Learning Support Programs
- Friendly atmosphere, culture of learning

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.

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