ETHICS SUBMISSION ASSISTANT SD

Probity Medical Research Inc•Waterloo, ON

13d•Hybrid

About The Position

Probity Medical Research (PMR) is seeking candidates for multiple Ethics Submission Assistant positions within the Study Department. This administrative support role involves supporting ethics submissions for clinical research trials, ensuring compliance with regulatory standards and ethics committees. The company is a rapidly growing organization committed to advancing clinical research through exceptional service. While remote work may be an option, candidates must be available and willing to report on-site as needed for specific tasks, meetings, or events. PMR offers competitive wages, healthcare benefits, and an inclusive work environment, seeking individuals looking for a long-term career and who are flexible to meet the demands of a growing organization.

Requirements

A bachelor’s degree or a college diploma in Regulatory Affairs, Scientific or Clinical Trial Management, or a related field (or equivalent experience).
1-2 years similar work experience (would be an asset).
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; sitting consistently at a desk using a computer to review multiple documentation platforms and resources to prepare and complete necessary work.
Attention to Detail
Excellent Communication Skills (oral and written)
Strong Organizational and Prioritization Skills
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

Nice To Haves

Science or clinical trials experience is preferred but not mandatory.
Preference to those that have CCRP certification.

Responsibilities

Draft, collect, and collate necessary information for initial ethics applications/submissions with various Ethics Committees and Site/Sponsor overview.
Ensure on-time submission rates for ethics applications.
Complete modification/amendment submissions, including reviewing responses/clarifications with Ethics Committees and Site/Sponsor overview.
Complete maintenance ethics reporting, such as drafting Annual Renewals, Safety, Protocol Deviation, and Closure reports within expected timelines.
Develop, revise, and review consent and assent forms and site-specific clauses, ensuring compliance with governing agencies (ICH GCP, FDA, Health Canada, etc.), ethics committees, and Site/Sponsor overview.
Develop related ICF/AF Flag Source Worksheets for revised materials.
Review approval documentation, post approved materials on the site-side (except ICF/AFs), and inform the Project Manager of approval processing completion within 36 business hours of receipt.
Work towards independence on up to 20 studies concurrently, completing accountabilities within expected timeframes, resolving submission challenges, and prioritizing tasks with Team Lead supervision.
Collaborate and communicate (oral and written) with different teams and team members, including the Team Lead, to qualify and coordinate information for ethics submissions.
Draft email correspondence for the Project Manager to facilitate communication with external stakeholders, or communicate directly to liaise with Site, Sponsor/CRO, and Ethics Committees.
Assist with continuous improvement initiatives within the team and department.
Work within Probity’s online platform (Portico) performing daily tasks, including maintaining study- and site-specific libraries, updating Study Management Forms, and ensuring study correspondence is saved.
Work within different Ethics Committee online portals performing routine tasks, including drafting/collecting information for submissions, submitting or providing submission instructions, navigating portals, maintaining documentation, ensuring proper document transfer, and communicating with Ethics Committees to resolve issues.
Track and update the Ethics Submission team’s key performance metrics regularly.
Assist and advise other team members on team processes, tools, and document/submission preparation.
Review tasks and provide feedback to Ethics Submission and Study Department team members.
Review and train new assistants on changes to key regulations and guidelines impacting the Ethics Submission team's work.