Study Coordinator

6 days ago

Scarborough, Canada Pharma Medica Research Inc. Full time

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 an **_Study Coordinator _**to join our clinic location in Scarborough.

The Study Coordinator supervises the planning for clinical studies. Supervises and/or performs all technical functions necessary to generate data in compliance with protocols, SOPs and GCP. Ensure that procedures are performed in a timely manner. Answer technical questions from technicians. Monitor Adverse Events. Supervision and direction of technical staff on study in terms of performance of functions**.** This position reports to the Manager, Clinical Operations and/or designate.

**Duties and Responsibilities**:

- Ensure that the final protocol, signed regulatory documents, and NOLs are available prior to study conduction.
- Prepare the study-specific staff schedule.
- Ensure that the study CRFs are prepared, study supplies are available, and and the clinic is set up prior to study check-in.
- Coordinate with the Pharmacy department to ensure that the study drugs are available in the clinic prior to study check-in.
- Set up and conduct pre-study protocol review meetings of study activities for technical team.
- Coordinate ordering of study specific materials to conduct clinical studies.
- Supervise and/or perform all technical functions: phlebotomy, ECG, vital signs and other clinical tasks to generate data in compliance with protocol, SOP and GCP.
- Generate client update and forward to Client Services as required.
- Perform final review of study documentation, ensuring accuracy according to protocol, SOPs and GCP.
- Ensure all study documentation is accurate, current, and complete according to study protocol, SOPs, GCP, and regulatory guidelines.
- Coordinate transcription of raw data onto CRFs where necessary.
- Ensure the timely submission of study files to QA and Report Writers.
- Address queries and findings from QC unit and QA's.
- Other duties as required.

**Qualifications**:

- Minimum B.Sc. degree with 1 year Phase I clinic experience or
- 2 years related experience within a Phase I clinical center.
- Clinical Research Coordinator designation as per ACRP guidelines.
- Excellent understanding 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.
- Excellent communication skills including excellent English verbal and written 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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