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.
