Clinical Trials Education Coordinator

This position's work location is fully remote with the occasional time onsite as needed. The selected candidate may only work remotely from a New England state (ME, VT, NH, MA, CT, RI).

The Office of Data Quality (ODQ) provides research support to the Dana-Farber/Harvard Cancer Center with a focus on quality assurance, quality control, and process improvement. The cancer center is made up of 5 Boston institutions including Dana-Farber Cancer Institute, Brigham and Women’s Hospital, Beth Israel/Deaconess Medical Center, Boston Children’s Hospital, and Massachusetts General Hospital. Functions of ODQ include protocol subject registration and randomization, clinical research auditing, data and safety monitoring, quality control of DF/HCC initiated clinical trial data, national protocol and investigator registrations, DF/HCC multi-center coordination oversight, participation in general clinical trials education, and committee management.

The Clinical Trials Education Coordinator II performs analytical and regulatory work directly related to DFHCC’s policies, reporting requirements and adherence to local, state, and federal regulations. This position is responsible for independent application of advanced knowledge in the area of clinical research, quality assurance, and health sciences research to advance DFHCC’s mission. The Education Coordinator II provides extensive support of educational resources and activities for research staff, as well as management of the annual NCI Investigator Registration process. This role requires comprehension of research study conduct, and significant judgement and decision making in interpreting and applying federal and/or DF/HCC requirements to research studies and personnel. The Clinical Trials Education Coordinator II reports to the Clinical Trials Education Manager.

The primary role of the Clinical Trials Education Coordinator II is to interpret DF/HCC policies and research regulatory requirements to provide guidance and education to the DF/HCC research community. This position acts as a communication leader for ODQ and the DF/HCC, will lend their voice to online learnings, and participate in live training presentations. They will also create and distribute official announcements to the research community as needed.

• Maintains central research personnel records of DF/HCC required trainings, including:
  • Identifies research staff that will be required to complete specific training per DF/HCC policy, and provides training materials, instructions, and guidance as needed.
  • Performs daily maintenance of staff OnCore records to reflect updated CITI Human Subject Protection, Good Clinical Practice, and other training certifications.
  • Sends regular training reminders, tracks upcoming training expiration dates, and independently fields inquiries related to educational requirements and resources; applies knowledge of DF/HCC and federal policies in making determinations and providing support.
  • Acts as an account administrator for the cancer center CITI program account, coordinates payment of annual CITI licensure fees, and provides support for using the CITI training platform for DF/HCC researchers.
  • Advises investigators and other research staff on education and DF/HCC policy requirements. Must assist in interpreting policies when responding to inquiries.
• Participates in DF/HCC policy development. Creates drafts of new policies and policy revisions. Identifies areas for potential policy changes.
• Develops and distributes research support educational materials, including:
  • Works to develop, refine, update, and revise content for e-learnings, guidance documents, etc.
  • Assists with scheduling and logistics for educational sessions.
  • Maintains content on the DF/HCC Clinical Research Support website. Proactively identifies and updates content as needed.
  • Facilitates the purchase of external educational resources and works to integrate these resources within DF/HCC. Maintains active CITI program membership for the center.
• Serves as the lead NCI Registration Coordinator for all DF/HCC physician investigators, which includes:
  • Provides direct support to over 700 DF/HCC physician investigators in completion and maintenance of their annual online registrations within the NCI Registration and Credentialing Repository System (RCR).
  • Tracks and distributes reminders and notices related to upcoming expiration dates, provides detailed instructions, and helps users to troubleshoot issues to ensure timely registration.
  • Works closely with the institutional clinical trials offices to ensure the coordination of registrations for their site’s investigators.
  • Maintains an updated list of physician investigator registration status for all DF/HCC physician investigators.
  • Develops instructional materials and templates for registrations and renewals as needed.
  • Works with the Clinical Trials Education Manager to identify areas requiring process improvement, and update materials and resources as needed.
• Provides coverage and support to other ODQ teams when needed and assists the department with additional special projects and administrative tasks.
  • For example, this may include developing materials and assisting with tasks related to employee onboarding, coordinating initiatives related to on campus space, distribution and purchasing of supplies and/or equipment, internal departmental trainings, etc.
• Works independently to handle routine and moderately complex scenarios and questions independently but may escalate unique cases to the Clinical Trials Education Manager.
• Works independently on education resource development and distribution; May be assigned or work with manager or other ODQ team members on larger projects and initiatives.
• May assist in the training and mentorship of new team members and junior staff. This may involve assigning tasks to others to facilitate project completion.

KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:

• Ability to communicate clearly and effectively with written and verbal English.
• Strong customer service and communication skills, both written and verbal.
• Demonstrated ability to deliver research education curricula in a complex organization.
• Demonstrated understanding of federal regulations governing the conduct of human subject research and good clinical practices.
• Willingness to learn and adapt to new computer systems and processes.
• Ability to make decisions that require judgement and integrity, to be flexible, and to organize, prioritize, and follow through on projects.
• An attention to detail, openness to constructive feedback, and willingness to chip in for the good of the team.

MINIMUM JOB QUALIFICATIONS:

• Bachelor’s degree in a scientific specialty or other relevant major preferred or equivalent work experience.
• 3 years of clinical research experience or experience in an education role in a medical/academic setting required.
• Strong grasp of federal regulations governing the conduct of clinical trials. Prior use of NCI RCR registration system or other similar registration systems is preferred.

Pay Transparency Statement: The hiring range is based on market pay structures, with individual salaries determined by factors such as business needs, market conditions, internal equity, and based on the candidate’s relevant experience, skills and qualifications. $74,300.00 - $82,900.00