Scientific Review is a requirement of the NCI Cancer Center Support Grant (CCSG) that funds the DF/HCC. All cancer-relevant research at DF/HCC member institutions must be reviewed and approved by a SRC or through expedited administrative scientific review for prioritization, as permitted by the CCSG. The SRC assesses a research protocols scientific merit, prioritization and feasibility of trial completion, as well as the progress of approved research terminating research that no longer meets those criteria. OHRS manages five SRC panels.
The IRB is an administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated. The DFCI IRB functions as a single IRB of record for the clinical institutions that comprise the DF/HCC. OHRS manages seven IRB panels.
The Senior Human Research Coordinator (Senior HRC) is expected to work independently applying human subject protection regulations, policies and guidance. This individual must have solid oral and writing skills and be able to effectively communicate with research staff at all of the Harvard clinical institutions that operate under the umbrella of the Dana-Farber/Harvard Cancer Center. The Senior HRC reports to the OHRS Associate Director.
Serve as an IRB member with the ability to approve certain types of protocol submissions eligible for expedited IRB review by a non-scientific reviewer. Independently review verification records appropriate for non-scientific reviewers.
Assist OHRS Leadership in identifying areas for enhancement to increase efficiency and compliance, as well as recommending proposed solutions.
Independently manage a portfolio of assigned protocols through the review, approval and post-activation process.
Independently prepare pre-review comments of protocol submissions and informed consent documents in anticipation of SRC/IRB reviews.
Train, educate and guide OHRS staff on reviewing and revising consent forms and other documents integral to the conduct of research involving human subjects.
When potential issues with protocol submissions are identified, manage these issues and implement solutions proactively.
Independently write clear, concise and timely SRC/IRB minutes.
Peer Review and edit IRB/SRC Minutes.
Advise study teams regarding relevant policies and regulations. Refer questions to other OHRS staff as appropriate.
Participate in the interview process and selection of new HRCs.
Train new HRCs and support their advancement and growth.
Answer questions of SRC and IRB members independently.
Assign additional duties to HRCs with consultation from Senior Staff.
Report to OHRS Leadership performance issues and concerns regarding HRC work product and work distribution.
Independently manage special projects as assigned.
Actively lead an internal OHRS committee and/or workgroup.
Lead IRB and SRC meetings.
Independently conduct training sessions within the DF/HCC community either to groups or in one-on-one sessions.
Facilitate meetings with DF/HCC research personnel. Occasionally represent OHRS at DF/HCC meetings including DSMC, Audit Committee and ClinOPS.
Provide support to a major OHRS projects or programs.
Perform other duties as assigned by the Associate Director.
Each Senior HRC supervises a small group of protocol management focused Human Research Coordinators.
Bachelor’s degree required.
Five or more years of experience working with SRC or IRB is required. Two years of experience may be substituted with an advanced degree.
Must be flexible, adapt quickly to frequent changes, be able to multi-task, prioritize and follow through on work assignments.
Demonstrate good time management skills, adaptability and the ability to work both independently and cooperatively.
Be able to multi-task, prioritize and work under tight deadlines. Be responsible for following through on work assignments. Practice good judgment and seek assistance as needed.
Operate independently with established guidelines for the majority of duties.
Effectively communicate with OHRS staff, investigators and other research personnel using excellent English language reading, writing, and speaking skills.
Prior knowledge of scientific and medical concepts and terminology related to oncology research involving human subjects.
Knowledge of Federal, state, and local regulatory requirements regarding the protection of human subjects in biomedical and behavioral research.
Ability to interpret, analyze and explain complex policies, procedures, regulations pertaining to human subjects research.
Ability to learn all operating procedures integral to scientific review and IRB review processes.
Certified IRB Professional (CIP) certification is expected within two years for staff without an advanced degree.
Dana-Farber Cancer Institute is an equal opportunity employer and affirms the right of every qualified applicant to receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, national origin, sexual orientation, genetic information, disability, age, ancestry, military service, protected veteran status, or other groups as protected by law.