Based in Waterloo, Ontario, Probity Medical Research (PMR) is a Canadian organization supporting the advancement of clinical research by partnering with research sites, pharmaceutical companies, and contract research organizations. Through our specialized administrative services, we help clinical research teams deliver studies that contribute to the development of new treatments and therapies.
At PMR, employees have the opportunity to contribute to meaningful work while developing specialized knowledge within the clinical research industry. Our teams collaborate across departments and with external partners, providing employees with exposure to a variety of projects, stakeholders, and opportunities to expand their skills.
As a growing organization, we value individuals who are eager to learn, contribute ideas, and help improve the way we work. We are committed to creating a supportive and inclusive workplace where employees can build their expertise, take ownership of their work, and grow alongside the organization.
PMR is an equal opportunity employer committed to providing a respectful and inclusive workplace. We offer a benefits program and an opportunity to build specialized experience within the clinical research industry while contributing to the continued success and growth of our organization.
The Project Management Assistant plays a vital role in supporting the successful execution of clinical research studies by coordinating site communications, managing administrative workflows, and ensuring regulatory compliance. Acting as a central liaison between sites, sponsors, and internal teams, this role facilitates clear, timely communication of study milestones and updates.
The Project Management Assistant manages study documentation, tracks project progress, and supports sites in responding to audits, deviations, and sponsor queries. With a focus on detail, organization, and proactive coordination, the Project Management Assistant helps drive study efficiency, maintain audit readiness, and contribute to overall project success.
We thank all applicants for their interest; however, only those selected for further consideration will be contacted.
Job Responsibilities
Communication & Liaison
- Collaborate with team members and provide assistance with their assigned studies.
- Regularly communicate project milestones, issues, study status, and progress updates with Project Management Team Lead.
- Serve as the primary contact for sites and sponsors to provide support, study updates, resolve issues as needed and facilitate smooth communication between stakeholders.
- Effectively communicate and distribute pertinent information to other teams and departments to facilitate timely and accurate task completion, ensuring alignment with project deadlines and objectives.
- Publish study announcements and study tasks on Portico to inform sites about site activation, implementation of protocol amendments and ICFs/IAFs, revised source, and other relevant announcements.
Administrative Support & Coordination
- Coordinate completion of regulatory documents, site start-up tasks, and approvals to ensure timely activation of sites/studies.
- Coordinate completion of site/study maintenance tasks to ensure timely completion of renewals, modifications/amendments, and study termination requests.
- Upload documents, study correspondence and maintain the Portico library and Study Management Forms, ensuring proper categorization and accuracy to support efficient retrieval.
- Track and monitor project schedules, tasks and key milestones using internal tools, providing regular progress updates to stakeholders to ensure timely task completion and alignment with project goals.
Documentation & Reporting
- Provide support to sites in drafting Note to Files as needed, ensuring accuracy and compliance with regulatory requirements.
- Assist and advise sites in addressing monitor queries and sponsor audits, ensuring timely resolution and adherence to sponsor needs.
- Provide guidance to sites on protocol deviation and adverse event reporting to ensure proper documentation and compliance with study protocols.
- Prepare and complete enrollment graphs to analyze recruitment goals and trends, enabling data-driven decisions to optimize study performance.
Miscellaneous
- Perform other duties and ad hoc assignments including approving Ethics Committee fee invoices.
Skills
- Communication Skills: Strong verbal and written communication skills, with the ability to communicate professionally and effectively with clinical research sites, sponsors, and internal stakeholders.
- Organizational Skills: Excellent organizational and administrative skills, with strong attention to detail and the ability to manage multiple studies, tasks, and deadlines simultaneously.
- Time Management and Prioritization: Ability to prioritize competing demands, manage workloads effectively, and consistently meet established deadlines.
- Documentation and Accuracy: Strong attention to detail and ability to maintain accurate, complete, and well-organized documentation and records.
- Problem-Solving: Ability to identify issues, assess information, and take a proactive approach to resolving administrative and project-related challenges.
- Technical Proficiency: Proficiency in Microsoft Office applications, particularly Word, Excel, and Outlook, with the ability to learn and navigate internal systems and project management tools.
- Interpersonal and Relationship Management: Ability to establish and maintain professional working relationships with internal and external stakeholders.
- Teamwork and Collaboration: Ability to work effectively both independently and as part of a cross-functional team.
- Adaptability: Ability to adjust to changing priorities, evolving study requirements, and competing deadlines while maintaining accuracy and efficiency.
- Initiative and Accountability: Demonstrates initiative, sound judgment, and accountability when managing assigned responsibilities and following through on tasks.
Qualifications & Requirements
- A bachelor's degree or diploma in Health or Life Sciences, Business Administration, Project Management, or a related field.
- 1–2 years of relevant experience in project coordination, clinical research administration, regulatory documentation, or a similar administrative support role.
- Familiarity with clinical research processes, regulatory documentation, and clinical trial requirements is considered an asset.
- Clinical research experience or experience working with clinical research sites, sponsors, or research teams is preferred but not required.
- Certified Clinical Research Professional (CCRP) certification is considered an asset.
- Strong proficiency in Microsoft Office applications, particularly Word, Excel, and Outlook.
- Demonstrated ability to manage multiple priorities, coordinate administrative workflows, and meet deadlines with minimal supervision.
- Self-motivated and proactive, with a positive attitude and the ability to take initiative, exercise sound judgment, and work independently while contributing effectively to a team.
Working Conditions
- Manual dexterity is required to use desktop computer and peripherals.
