The Office for Human Research Studies (OHRS) manages Scientific Review and Institutional Review Board (IRB) review for the institutions that comprise the Dana-Farber Harvard Cancer Center (DF/HCC): Beth Israel Deaconess Medical Center, Brigham and Women's Hospital, Boston Children's Hospital, Dana-Farber Cancer Institute and Massachusetts General Hospital. There are five Scientific Review Committees (SRC) and seven IRBs that oversee cancer related human subject research for DF/HCC. As of May 2017, the OHRS manages more than 3,000 new and ongoing DF/HCC research protocols with more than 12,000 submissions received for SRC / IRB review per year. OHRS is also responsible for HIPAA review of research.
The Associate Director is responsible for representing OHRS at DFCI and DF/HCC meetings and ensuring decisions are compliant with the human subject protection regulations. The Associate Director is expected to work independently, and can see the high level operational and substantive issues and devise appropriate management plans. This individual must have solid oral and writing skills and can effectively communicate with senior officials at all the Harvard clinical institutions that operate under the umbrella of the DF/HCC.
The Associate Director is a member of the OHRS Senior Staff and reports to the Director. The Associate Director supervises the Senior Human Research Coordinators (HRC) and indirectly all the protocol focused HRCs. The Associate Director is responsible for ensuring staff compliance with the Cancer Center Support Grant (CCSG) Protocol Review and Monitoring (PRMS) requirements as they relate to SRC review as well as compliance with FDA and HHS regulations for IRBs.
PRIMARY DUTIES AND RESPONSIBILITIES:
Serves as an IRB member on the seven IRB committees.
Attend SRC committees as an administrator ensuring that the requirements of the CCSG are met.
Creates and implements ongoing education programs for SRC and IRB members.
Serves as a liaison to the clinical trials offices of the five Harvard institutions that comprise the DF/HCC consortium (e.g. BIDMC CCTO, MGH CCPO and DFCI CTO)
Represents the OHRS at DF/HCC meetings including but not limited to:
Data Safety and Monitoring Committee (DSMC)
Clinical Operations Meeting
Represent OHRS at inter-institutional meetings including the Regulatory Committee of the Harvard Catalyst (CTSC)
Liaison with the DFCI Office of the General Counsel, DFCI Research Compliance, DFCI Office of Research Integrity for guidance and advice on legal issues impacting the operations of OHRS
Responsible for ensuring prompt reporting of Non-Compliance, Unanticipated Problems and Suspensions of Research to the appropriate oversight agency, e.g. FDA, OHRP.
Implementation and management of the HIPAA regulations as they relate to research
Maintain the DFCI IRBs AAHRPP accreditation on behalf of the DF/HCC
Responsible for reviewing requests to share or transfer data or materials outside of DFCI to ensure requests align with previous regulatory determinations and applicable federal requirements.
Responsible for maintaining the DFCI IRB Policies and Procedures and training protocol focused HRCs on regulatory and operational changes
Monitors and redistributes protocol focused HRC workloads as needed
Train new protocol focused HRCs on SRC and IRB polices and procedures
Represent OHRS at outside conferences and meetings (e.g. PRIM&R, AAHRPP)
Assists with projects as directed by the OHRS Director
The Associate Director serves as the Acting Director of the OHRS when the Director is out of the office.
The Associate Director, as the Acting Director, has the authority to make decisions that can be made by the Director.
The Associate Director directly supervises the Senior Human Research Coordinators.
The Associate Director also supervises, but does not do the performance evaluations, for all protocol focused human research coordinators in terms of reviewing and approving verification records; minutes; and other records.
The Associate Director is responsible for reviewing and/or overseeing that IRB determinations are compliant with the human subject regulations and HIPAA.
The Associate Director is responsible for supervising any protocol focused human research coordinators assigned to assist in an audit or compliance matter or any other matter assigned to the Associate Director by the Director.
Bachelor's degree required
Advanced degree in law, policy or ethics or seven years of experience in regulatory compliance required.
Must have at least four years of experience in a cancer center and/or working with an academic IRB.
Must have at least four years of staff management experience.
Demonstrated expertise in application of federal regulations to non-clinical research.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Knowledge of Federal, state, and local regulatory information regarding the protection of human subjects in biomedical and social-behavioral research
Ability to interpret regulatory requirements and put those into policies and procedures
Strong communication skills necessary to allow productive communication between OHRS, DF/HCC Leadership, Investigators and other research personnel
Understanding of or ability to learn procedures integral to scientific review
Problem solving, decision-making and analytical skills necessary to identify problems and proposed solutions and the ability to implement solutions
Ability to work independently and cooperatively
Flexibility and motivation to work on special projects relating to the mission of OHRS as directed by the Director
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.