ETHICS SUBMISSION ASSISTANT SD - #223967

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 candidates to fill multiple Ethics Submission Assistant positions within the Study Department. The candidate chosen will be responsible for supporting ethics submissions for multiple studies, ensuring compliance with regulatory standards and ethics committees. The ideal candidate is someone who is looking for a long-term career and is flexible to meet the demands of a rapidly growing organization..

While this role may offer flexibility with remote work, all applicants must be available and willing to report on-site as needed. Being on-site may not be a regular requirement but is essential for certain tasks, meetings, or events that may arise.

We thank all applicants for their interest, however, only those selected for further consideration will be contacted.

Job Responsibilities & Duties

Ethics Submissions
• Draft, collect and collate necessary information to complete the initial application/submission with various applicable Ethics Committees along with Site/Sponsor overview.
• Ensure on-time submission rate for ethics applications.
• Complete modification/amendment submission, including review response/clarification with various applicable Ethics Committees along with Site/Sponsor overview.
• Complete maintenance ethics reporting, such as drafting Annual Renewal, Safety, Protocol Deviation, and Closure reports within expected timelines ensuring compliance with applicable Ethics Committees and Site/Sponsor overviews.
• Develop, revise, and review consent and assent forms and site-specific clauses ensuring compliance with applicable governing agencies (i.e., ICH GCP, FDA, Health Canada etc.), ethics committees and with Site/Sponsor overview.
• Develop related ICF/AF Flag Source Worksheets for revised materials, as applicable.
• Review approval documentation, posting approved materials on the site-side with the ethics approval dates (except for the ICF/AFs), and informing the Project Manager of approval processing completion within 36 business hours of approval being received.
• Work towards being independent on up to 20 studies at a time throughout the lifecycle of the study, while completing all accountabilities within expected time frames, resolving submission challenges, and prioritizing competing tasks with Team Lead supervision.

Collaboration and Communication
• Collaborate and communicate (oral and written) with different teams and team members, including Team Lead to qualify and coordinate necessary information for ethics submissions.
• Draft email correspondence for Project Manager to assist with communication with external stakeholders, or communicate directly, as needed to liaise with Site and Sponsor/CRO and Ethics Committees.
• Assist with continuous improvement initiatives within the team and department.

Online Platforms and Database Management
• Work within Probity’s online platform (Portico), performing daily tasks including:
• Maintain study- and site-specific libraries to ensure all necessary ethics-related documentation is uploaded and clearly formatted for site use, timely tracking, and audit readiness
• Update Study Management Forms with relevant ethics-related information throughout the lifecycle of the study
• Ensure study correspondence is saved in the designated libraries in a timely manner
• Work within the different Ethics Committee’s online portals performing routine tasks including:
• Draft, collect and collate necessary information to complete timely ethics submissions.
• Submit or provide submission instructions to necessary personnel.
• Navigate the portal, maintain documentation, and ensure proper document transfer.
• Communicate with the Ethics Committee to resolve ethics submission issues.
• Track and update the Ethics Submission team’s key performance metrics regularly.

Training and Knowledge Sharing
• Assist and advise other team members, including Study Department 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 that impact the work of the Ethics Submission team.

Skills
• 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

Qualifications & 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).
• 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; sitting consistently at a desk using a computer to review multiple documentation platforms and resources to prepare and complete necessary work.

Working Conditions
• Manual dexterity is required to use a computer and peripherals.