Clinical Trial Coordinator Jobs

About Us:

Source Nutraceutical, Inc. (SNI) is a fast-growing company with offices in Winnipeg, Manitoba and Toronto, Ontario. The company is an integrated “one-stop shop” for regulatory affairs, clinical research, quality assurance, packaging and labeling compliance, marketing support, and fulfillment needs. We have a substantial client base that is constantly growing.

SNI offers the opportunity to further professional development and technical expertise. We provide competitive wages and benefits, free parking, and more. We offer an environment that is team team-oriented and focused on continuous improvement!

Responsibilities:

This position of Clinical Trial Coordinator reports to the Director, Clinical Affairs & Regulatory Strategy. The successful candidate is primarily responsible for conducting/coordinating clinical trials, and supporting the day-to-day operations of our clinical trial site. Other areas of responsibility include:

• Processing, shipping, and/or storage of blood samples included blood and urine samples collected during study participant visits.
• Assisting in entry and compilation of the study data, and with review of study final report(s) as necessary.
• Managing and handling the flow of test article and placebo.
• Preparing and managing the clinical Trial Master File (TMF) during the clinical trial.
• Complete administrative tasks related to maintaining project files and archiving.
• Performing duties related to clinical trial operations, including preparing required paperwork for study visits, scheduling study participant visits, reminder calls for study visits, answering study participant's inquiries regarding the study, coordinating schedules of staff required for study visits, maintaining financial records, and ensuring participant reimbursements for expenses and organizing and filing of confidential study records.
• Preparing and/or reviewing components of clinical trial-related regulatory files, including Health Canada clinical trial applications (CTAs), research ethics board (REB) applications, study protocols, informed consent forms (ICFs), case report forms, safety summaries, study recruitment materials.
• Managing clinical trial documentation and team communications to ensure timely and accurate sharing of clinical trial strategies and operational status.
• Conducting clinical trial procedures according to International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) guidelines.
• Reviewing and approving vendors and contractor’s invoices.
• Assisting in the preparation and submission of clinical trial applications to Health Canada and/or the U.S. FDA (Food and Drug Administration).
• Supporting clinical trial team governance, particularly completion of clinical trial milestones and deliverables within projected budget and timelines.
• Procuring, managing and handling clinical trial supplies.
• Provide support to other departments as required.
• Managing clinical trial participant recruitment and enrollment.
• Preparing and submitting Research Ethics Board (REB) applications.

Position Requirements and Experience:

• A positive attitude.
• Excellent written and oral communication skills.
• A high standard of accuracy and attention to detail.
• Strong inter-personal skills.
• Openness to the potential for a flexible work schedule.
• The ability to thrive in an environment of growth and change.
• Proficiency with Microsoft Word, Excel, and PowerPoint.
• A minimum of a bachelor’s degree (BSc) in Life Sciences, Nutrition, Food Science, or a related discipline.
• The ability to analyze, organize, prioritize, and manage multiple projects.
• Knowledge and experience in ICH/GCP and Good Documentation Practice (GDP).
• Must be eligible to work in Canada.
• The ability to work as a member of a team in a timeline-driven environment.

Assets:

• A desire to maintain and/or improve current knowledge of relevant regulations pertaining to the job function, via ongoing professional development activities (i.e., internal training and/or industry educational opportunities; professional affiliations with industry associations).
• Knowledge and/or experience in working with Clinical Trial Management System (CTMS), e-consent processes, e-data collection (EDC), and storage.
• Phlebotomy certification.
• Experience working with project management software.
• Additional education and/or professional certifications would be an asset, including:
• Familiarity/experience with the preparation and submission of clinical trial-related regulatory and/or research ethics applications.
• Certified Associate of Project Management (CAPM).
• Certifications in the area of clinical trials.
• Master of Science (MSc) degree.
• Certified Clinical Research Coordinator (CRC).
• Medical/technical writing experience.

If you are passionate about the clinical trials industry and the support of health and/or drug product commercialization, then this position may be for you!

Please send your resume [email protected] 12, 2023.

We thank those who apply, however only qualified applicants will be contacted.