Manager, Clinical Trials Education

Primary Duties and Responsibilities

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

Knowledge, Skills and Abilities:

? Expert knowledge of federal regulations regarding human subject research protections, FDA and ICH Good Clinical Practices.
? Prior experience in the conduct of clinical trials is required. 

Minimum Job Qualifications:

? Bachelor's degree (BA, BS) in life sciences, nursing, or other health related discipline is preferred.
? 5 years? experience in clinical trials; oncology experience preferred.
? 2 years? experience supervising projects and/or staff.
? Knowledge of federal regulations and biologics regulations and/or experience in the conduct of clinical trials is required. 

Supervisory Responsibilities:

This position will supervise 1-2 direct reports

Patient Contact:

No