SOURCE NUTRACEUTICAL, INC.
Winnipeg, MB, CANADA R3T 1T4
Junior Clinical Trials and Regulatory Affairs Specialist (Youth Internship)
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 clinical research, regulatory affairs, quality assurance, packaging and labeling compliance, and marketing support. We have been in business for 20+ years, and we have a substantial client base that is consistently 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-oriented and focused on continuous improvement.
The 8-month term position of Junior Clinical Trials and Regulatory Affairs Specialist reports to the Senior Director of Clinical Affairs and Regulatory Strategy, and is responsible for supporting clinical trial operations and regulatory affairs-related activities.
This position will be an in-person role at our corporate headquarters in Winnipeg, Manitoba.
Tasks will include:
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- Providing project coordination support to the completion of client clinical trial (CT) and/or regulatory affairs (RA)-related milestones and deliverables within projected budget and timelines.
- Reviewing components of client RA files, including pre-market regulatory applications, marketing compliance reviews, quality assurance-related supporting documentation, etc.
- Completing scientific literature review searches and quality appraisal processes in support of client regulatory initiatives.
- Reviewing components of CT-related regulatory files, including research ethics board (REB) applications, Health Canada clinical trial applications (CTAs), study protocols, informed consent forms (ICFs), case report forms, electronic data capture (EDC) platforms, safety summaries, study recruitment materials.
- Completing CT-related administrative tasks related to maintaining project files, standard operating procedures (SOPs), trial master files (TMFs) and archiving.
- Assisting the CT and RA teams with document management and versioning.
- Supporting CT operational procedures, including data collection from study participants.
- Managing and handling operational flow of various CT equipment and supplies.
- Assisting with CT recruitment processes, including study advertising management, completion of participant questionnaires, and supporting site scheduling for CT staff and study participants.
- Managing study appointments internal clinical trial management software (CTMS) relative to participant scheduling for CTs.
- Reviewing CT and/or RA-related documentation as a peer reviewer.
- Supporting other CT and/or RA-related operational administrative tasks as required.
Eligibility:
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- Recent Canadian University graduate in Human Health and Nutrition; Biological Science; Biotechnology; Food Science; or a related discipline.
- Located and available to work in person at the SNI head office (Winnipeg area).
- Eligibility to work in Canada (i.e., Canadian citizen, permanent refugee or having refugee status) and to participate in the Youth Employment and Skills Strategy (YESS) program (i.e., candidates under 30 years of age).
- In order to achieve a representative workforce, selection may be based on qualified candidates self-declaring as being a member of one or more employment equity or equity-seeking groups. We encourage any such candidates, including indigenous or immigrant youth, members of the 2SLGBTQ+ community, racialized groups, religious or official language minorities, and/or youth with disabilities, to self-identify and apply.
Position Requirements and Experience:
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- Proficiency with Microsoft Word, Excel, Powerpoint and Outlook.
- A high standard of accuracy and attention to detail.
- Strong inter-personal skills.
- The ability to contribute to multiple projects simultaneously, on a regular basis.
- The ability to work collaboratively as a member of a team in a timeline-driven environment.
- Excellent written and oral communication skills.
- A positive working attitude.
- The ability to thrive in an environment of growth and change.
Assets:
- Additional education and/or professional certifications would be an asset, including:
- Master of Science (MSc) degree.
- Certified Clinical Research Coordinator (CRC).
- Experience working with project management software.
- Experience with clinical trial project coordination, operations, and/or data management.
- Knowledge and/or experience in working with a clinical trial management system (CTMS), e-consent processes, and electronic data capture (EDC).
- Familiarity/experience with the preparation and submission of clinical trial and/or regulatory affairs applications.
- Scientific technical writing experience.
This is a 8-month term position with the potential to grow into a full-time permanent role.
If you are passionate about clinical trials and/or regulatory affairs, and would like to gain experience working with industry in support of new product commercialization, then this position may be for you!
When submitting your application, please confirm that you meet the eligibility criteria outlined above.
We thank those who apply, however only qualified applicants will be contacted.
