Manager, Clinical Trials Education
- Chair the DF/HCC Education Subcommittee
- Identifying appropriate representatives from DF/HCC member institutions
- Managing committee meetings, agendas, and documentation
- Working with the committee to identify educational needs and opportunities, and develop education resources in response to those needs
- Oversight of education-related projects and delegation/distribution of project work amongst the committee members
- Conduct of live educational activities for DF/HCC clinical research staff, including:
- Scheduling topics and speakers for DF/HCC live training sessions
- Recording and posting the training sessions for future viewing
- Overseeing staff who coordinate meeting logistics (location, AV requirements, etc.)
- Reporting metrics and statistics to the ODQ Director and senior DF/HCC leadership
- Oversee the development, review, and approval process of the DF/HCC Policies and Operations, which includes the following:
- Management of the Clinical Research Operations Subcommittee (CLINOPS) operations and documentation, including approval of policy decisions
- Presenting feedback and recommendations from the research community and Education Subcommittee; recommending policy changes, and draft policy writing
- Distribution of draft policies for comment, collection of feedback, policy document cleanup and finalization and routing policies for approval sign off
- Maintaining version history of policies and operations
- Announcing policy changes to the DF/HCC community and posting revised policies and operations on the DF/HCC website
- Providing background or template training materials to institutional clinical trial offices to support implementation of policy changes
- Developing and maintaining e-learning modules for DF/HCC required trainings and additional topics based on need.
- Designing, creating, recording, and updating e-learning modules for posting to the DF/HCC website.
- Ensuring training resources are updated with regulatory/policy changes.
- Identifying where additional modules are needed and promoting existing educational materials
- Administration of the DFCI CITI training program account
- Management of the institutional CITI account
- Tracking completion of required CITI training and notifying research staff whose training has lapsed or is missing
- Ensure compliance with investigator annual NCI registration requirements
- Oversight of ODQ staff who provide direct support to investigators with submitting registration materials in the NCI RCR system
- Responsible for tracking and reporting to leadership on compliance with registration requirements and deadlines; provide proactive notifications and reminders
- Escalate non-compliance to institutional clinical trials offices, institutional leaders, and CLINOPS as needed
- Act as the face of ODQ for DF/HCC communications
- Sending broadcast announcements as needed, including for important updates, changes, and to promote educational resources
- Overseeing and curating ODQ’s online presence, resources, and educational materials on the DF/HCC website
- Ensuring excellence in customer service to investigators and study teams. Oversees staff who are responsible for email communications in the ODQ Education mailbox
- Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is preferred.
- 5 years of experience in clinical trials; oncology experience preferred
- 2 years of experience supervising projects and/or staff.
- Expert knowledge of federal regulations regarding human subject research protections, FDA and ICH Good Clinical Practices.
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