At a Glance
- Tasks: Drive regulatory affairs for Canadian clinical trials and coordinate approvals remotely.
- Company: Join Premier Research, a leader in clinical start-up solutions.
- Benefits: Flexible remote work, competitive salary, and opportunities for professional growth.
- Other info: Work independently in a dynamic environment with a focus on accuracy.
- Why this job: Make a real impact in biotech and medtech while advancing your career.
- Qualifications: 3+ years in study start-up and a degree in a related field.
The predicted salary is between 58500 - 71500 $ per year.
Drive regulatory affairs for Canadian clinical trials through submission planning, document review, and approval coordination.
Work remotely with Premier Research's clinical start-up team.
This Site Start-up Associate II position supports biotech, medtech, and specialty pharma studies through country-level start-up activities.
You prepare EC, IRB, regulatory authority, and hospital approval applications while addressing submission issues.
You review essential documents and informed consent materials, and may negotiate investigator contracts and budgets.
Success requires independent, accurate work within agreed timelines.
Key Responsibilities
- Coordinate forecasts for submission and approval milestones
- Submit local regulatory and institutional approval applications
- Provide rationale and contingency plans for identified delays
- Review sponsor and investigator essential documents
- Adapt informed consent and patient document templates
Requirements
- Three or more years of direct study start-up experience
- Degree in clinical, science, or health-related discipline
- Detailed knowledge of country-specific clinical trial requirements
- Working knowledge of Health Canada and applicable regulations
- Ability to work independently with minimal supervision
Bring Canadian regulatory affairs experience, submission expertise, and careful document review to Premier Research study start-up projects.
Regulatory Affairs Site Start-Up Associate employer: Premier Research Group
At Premier Research, we pride ourselves on being an exceptional employer that values innovation and collaboration in the healthcare sector. Our remote work culture fosters flexibility and inclusivity, allowing you to thrive while making a meaningful impact in dermatology. With ample opportunities for professional growth and a commitment to employee well-being, you'll find a rewarding career path that aligns with your passion for transforming patient care.
