Clinical Trial Coordinator

4 weeks ago


Toronto, Ontario, Canada Pharma Medica Research Inc. Full time
Study Coordinator Job Description

Pharma Medica Research Inc. is a leading contract research organization specializing in early phase clinical trials. We are seeking a highly skilled Study Coordinator to join our team at our Scarborough clinic location.

The Study Coordinator will be responsible for planning and executing study activities under the supervision of the Study Coordinator II. This includes generating data in compliance with protocols, SOPs, GCP requirements, and other regulatory guidelines. The successful candidate will be responsible for ensuring subject safety, monitoring adverse events, and coordinating with the Project Management department.

Key Responsibilities:

  • Plan and supervise the timely execution of studies
  • Generate study summaries based on protocols
  • Ensure regulatory documents are available prior to study check-in
  • Coordinate the ordering of study-specific materials
  • Conduct pre-study protocol review meetings
  • Prepare study schedules in compliance with study requirements
  • Communicate with the Screening department to address queries pending at check-in
  • Ensure study drugs are received prior to study conduction
  • Communicate with the Principal Investigator to ensure Investigator presence
  • Supervise and perform technical functions, including phlebotomy, ECG, and vital signs
  • Perform safety-related procedures and health monitoring
  • Ensure subject safety by documenting and following up on Adverse Events
  • Ensure all study documentation is accurate, current, and complete
  • Coordinate with the Project Management department regarding study-related issues and project deadlines
  • Assist in resolving conflicts among subjects and address subjects' concerns
  • Generate client updates and forward to the Project Management department as required
  • Coordinate with the accounting department regarding study subjects' compensation
  • Ensure timely shipping of clinical and analytical samples
  • Perform final review of study documentation and ensure accuracy
  • Ensure timely completion of deviation forms and post-study laboratory reports
  • Address queries and audit findings from QC and QA
  • Coordinate the transcription of raw data onto CRFs
  • Update subjects' files for outstanding follow-ups and non-compliance

Qualifications:

  • Minimum B.Sc. degree with 1 year experience in conducting clinical trials or;
  • M.Sc. degree with adequate knowledge of conducting clinical trials;
  • Working knowledge of Phase I study protocols and conduct;
  • GCP training;
  • Proficiency in computer usage and software applications;
  • 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;
  • Flexibility with changes in working schedules/shifts;
  • Exceptional organizational skills.

We offer a competitive compensation plan, opportunities for advancement and career progression, a generous Employee Milestones Awards Program, Corporate Discounts Program, Learning Support Programs, and a friendly atmosphere with a culture of learning.

Please note that 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.



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