Working under general direction of the Manager and/or Director, the Clinical Trial Associate is assigned on Alzheimer’s clinical research trials regulatory tasks. Clinical Trial Associates are primarily responsible for compliance with current regulations, policies, procedures, coordination regulatory documentation activities, IRB submissions, maintain master files (paper and electronic), liaison with the sponsor for startup and ongoing clinical trial activities.
Key Responsibilities
- Clinical Trial Start-up Activities Prepare, compile, and submit regulatory packages to Sponsor/CRO and Ethics Committees/IRBs.
- Coordinate the collection and review of essential study documents, including clinical protocol, Investigator’s Brochure (IB), informed consent forms (ICFs), and site-level documentation.
- Ensure compliance with applicable regulations (e.g., ICH-GCP).
- Track submission status, support regulatory strategy, and collaborate with internal and external stakeholders.
- Ongoing Study Management Prepare and submit regulatory amendments including clinical protocol, Investigator’s Brochure (IB), informed consent forms (ICFs), and site-level documentation.
- Manage ongoing submissions including annual reports, safety reports, updated documents Ensure compliance with regulatory commitments, maintain Investigator Site File/eInvestigator Site File, respond to authority queries, and support audits and inspections including CAPA follow-up.
- Act as point of contact for assigned studies, provide guidance to cross-functional teams, collaborate with clinical and start-up teams, and contribute to process improvements.
- Training & Study Oversight Coordinate assignment and completion of training for internal team members and external vendors Track and ensure training compliance in alignment with study requirements and regulations Develop and maintain Delegation of Authority Logs to ensure clear documentation of roles and responsibilities
Requirement
- A minimum of 2 years’ experience in a Regulatory Specialist role supporting a clinical site and/or sponsor organization is Strong attention to detail, excellent organizational and communication skills Ability to manage multiple priorities and work effectively in a team Fluency in both
- French and
- English (spoken and written) is required
- Technical
- Skills: Knowledge of ICH-GCP and regional regulatory requirements (EMA, FDA, Health Canada). Experience with submission processes and regulatory systems eISF platforms).
- Core Competencies Regulatory & GCP Compliance– Strong understanding of ICH-GCP guidelines, regulatory requirements, and clinical trial documentation standards.
- Organization & Attention to Detail– Ability to manage multiple studies, maintain accurate records, and ensure completeness of regulatory documentation.
- Communication & Collaboration– Effective communication skills with investigators, sponsors, monitors, regulatory bodies, and internal study teams.
- Problem Solving & Critical Thinking– Ability to identify compliance gaps, resolve study-related issues, and support corrective actions in a timely manner.
- Adaptability & Time Management– Ability to prioritize competing tasks, meet deadlines, and adapt to changing study and regulatory requirements in a fast-paced environment.
