Reg Docs

Based in Waterloo, Ontario, Canada Probity Medical Research (PMR) is an administrative support company that partners with clinical research sites and pharmaceutical companies to provide essential administrative services for clinical research trials. As a rapidly growing company, we are committed to advancing clinical research through exceptional service. PMR is an equal-opportunity employer, offering competitive wages, healthcare benefits, and an inclusive work environment. PMR is looking for a Reg. Docs & Admin Assistant, responsible for preparing, reviewing, and organizing regulatory documents. We thank all applicants for their interest, however, only those selected for further consideration will be contacted. Job Responsibilities Regulatory Document Preparation & Management Execute administrative tasks as assigned by the Study Department’s Project Management Team, ensuring completion within the established study start-up timelines, sponsor/CRO requirements and site request. Document Handling & Compliance Upload and maintain study documents to the Clinical Trial Management System (CTMS), ensuring accuracy, completeness and version control. Prepare regulatory documents for signature, ensuring timely execution and compliance with sponsor and regulatory guidelines. Draft, review and maintain General Practitioner (GP) letters and registered letters as per study requirements. Develop start-up letters and training log templates for efficient study initiation. Prepare and customize site-specific documents, such as consent/assent forms and referral letters. Create and maintain flag source worksheets for tracking key regulatory updates. Linking applicable Institutional Review Board (IRB) guidance documents to Serious Adverse Events (SAE) and Protocol Deviation (PD) libraries in the CTMS, ensuring accessibility for compliance and audit readiness. Post relevant tasks and announcements to Portico to support efficient study communication. Communication & Coordination Monitor the shared team inbox at least twice per working day, ensuring timely processing and response to regulatory document submissions. Coordinate with internal stakeholders to facilitate document approvals, regulatory compliance and study readiness. Tracking & Compliance Maintain individual and team trackers to document task progress and completion, supporting departmental KPIs and providing visibility during team absences. Ensure all study documents are prepared, handled, and stored in compliance with ICH-GCP, Health Canada, FDA, and other relevant regulatory requirements. Identify opportunities to enhance workflow efficiency, document management practices, and compliance adherence. Additional Responsibilities Complete assigned tasks with minimal supervision, demonstrating strong problem-solving skills and initiative. Support ad hoc assignments and other duties as assigned to contribute to team success and organizational objectives. Skills Attention to detail Excellent communication skills (oral and written) Time management skills MS Office proficiency Ability to work independently and be a team player Adaptable/flexible Collaborative Solid problem-solving skills Creative and innovative thinking Decision making Qualifications A bachelor’ degree or a college diploma in Regulatory Affairs, Clinical Trial Management, or related field 1-2 years similar work experience an asset Science or clinical trials experience is preferred but not mandatory Preference to those that have CCRP certification Self-starter with positive attitude, ability to take initiative and work with minimal supervision Ability to execute and complete overlapping projects High level of critical and logical thinking, analysis, and/or reasoning Enjoys administrative work; working consistently at a desk working with multiple documentation platforms and resources . Working Environment Each department has their own training requirements for in-office, hybrid or remote. Generally, most positions will be eligible for a hybrid training schedule or remote. Home office setup requirements include a secure and reliable internet connection, an additional monitor, ergonomic workspace and privacy. This is an option, as staff can choose to work full-time from our office. Manual dexterity is required to use a computer and peripherals #J-18808-Ljbffr