Job Description

Pharma Medica Research (PMRI) Inc. is a Contract Research Organization that strives for innovation and original solutions in a highly regulated and competitive industry. If your career goals align with innovation and original thinking you will be the perfect candidate to be part of an inclusive, adaptable, and forward-thinking organization. Our reputation for delivering high quality research is outstanding. At PMRI we are committed to making a difference in healthcare and people’s lives. Come join our team!

We are always looking for top talent to join our amazing team! Currently we are looking for a Senior Study Coordinator in our Scarborough clinic!

The Senior Study Coordinator supervises the planning for clinical studies. Supervise and/or perform all technical functions, necessary to generate data in compliance with Pharma Medica Research Inc ( PMRI ) protocol, SOP and GCP. 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. Supervision and direction of technical staff on study in terms of performance of functions. This position reports to Manager, Clinical Operations and/or designate.

Duties and Responsibilities:

• Review protocol and conduct pre-study protocol review meetings with the clinic team.
• Ensure that the study file and preparation is completed on time prior to study conduction, including study drugs, study supplies, equipment and materials needed for the study.
• Prepare the study-specific staff schedule in coordination with the clinic schedule coordinator.
• Ensure that the final protocol, signed regulatory documents, and NOLs are available prior to study conduction.
• Supervise and/or perform all clinic functions: phlebotomy, ECG, vital signs and other clinical tasks.
• Supervise clinic teams: MLAs, GLs, and ASCs/SCs.
• Ensure that all study procedures are performed and documented according to the study protocol, SOPs, GCP, and regulatory guidelines.
• Coordinate with the Accounting department regarding timely preparation of subjects’ compensation.
• Generate client update and forward to the Project Manager as required.
• Ensure the timely submission of study files within a specified timeline.
• Ensure that the analytical and clinical samples are processed and sent to the laboratory in a timely manner.
• Address queries and findings from QC unit and QA’s.
• Assists new Assistant Study Coordinator and new Study Coordinator training.
• Assists in hiring and training of MLA’s and Group Leader, MLA’s.
• Other duties as required.

Qualifications:

• Minimum B.Sc. degree with 3 years Phase I clinic experience or 2 years related experience within a Phase I clinical center.
• Clinical Research Coordinator designation as per ACRP guidelines.
• MSc with experience preferred
• 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

We offer:

• Competitive compensation plan
• 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

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.

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