SOURCE NUTRACEUTICAL, INC.
Winnipeg, MB, CANADA R3T 1T4
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:
- Conducting clinical trial procedures according to International Conference on Harmonization/ Good Clinical Practice (ICH/GCP) guidelines.
- Managing clinical trial participant recruitment and enrollment.
- 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.
- Processing, shipping, and/or storage of blood samples included blood and urine samples collected during study participant visits.
- Supporting clinical trial team governance, particularly completion of clinical trial milestones and deliverables within projected budget and timelines.
- 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.
- Preparing and submitting Research Ethics Board (REB) applications.
- Assisting in the preparation and submission of clinical trial applications to Health Canada and/or the U.S. FDA (Food and Drug Administration).
- Managing clinical trial documentation and team communications to ensure timely and accurate sharing of clinical trial strategies and operational status.
- Preparing and managing the clinical Trial Master File (TMF) during the clinical trial.
- Managing and handling the flow of test article and placebo.
- Procuring, managing and handling clinical trial supplies.
- Reviewing and approving vendors and contractor’s invoices.
- Complete administrative tasks related to maintaining project files and archiving.
- Assisting in entry and compilation of the study data, and with review of study final report(s) as necessary.
- Provide support to other departments as required.
Position Requirements and Expertise:
- A minimum of a bachelor’s degree (BSc) in Life Sciences, Nutrition, Food Science, or a related discipline.
- Knowledge and experience in ICH/GCP and Good Documentation Practice (GDP).
- The ability to work as a member of a team in a timeline-driven environment.
- The ability to analyze, organize, prioritize, and manage multiple projects.
- A high standard of accuracy and attention to detail.
- Excellent written and oral communication skills.
- Strong inter-personal skills.
- A positive attitude.
- The ability to thrive in an environment of growth and change.
- Proficiency with Microsoft Word, Excel, and PowerPoint.
- Openness to the potential for a flexible work schedule.
- Must be eligible to work in Canada.
Assets:
- Additional education and/or professional certifications would be an asset, including:
- Master of Science (MSc) degree.
- Certified Associate of Project Management (CAPM).
- Certified Clinical Research Coordinator (CRC).
- Phlebotomy certification.
- Certifications in the area of clinical trials.
- Knowledge and/or experience in working with Clinical Trial Management System (CTMS), e-consent processes, e-data collection (EDC), and storage.
- Familiarity/experience with the preparation and submission of clinical trial-related regulatory and/or research ethics applications.
- Experience working with project management software.
- Medical/technical writing experience.
- 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).
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!
We thank those who apply, however only qualified applicants will be contacted.
