The primary responsibility of the Associate Director, Medical Review (ADMR) is to manage the scientific review process and ensure that the various committees are conducting consistent reviews. In addition, the ADMR works with the chairs of the committees and the members to identify issues that impact scientific merit, feasibility of the research and prioritization and work towards the creation of policies, procedures and practices that will ensure a robust scientific review process.
The ADMR serves as a member of all seven institutional review boards and works to ensure consistency between scientific review and IRB review of research protocols.
The ADMR supervises the Human Research Coordinators who are responsible for SRC minutes; participates in the general management of the office; and is integral to the creation, maintenance and evolution of the various systems, policies and procedures that support the work of the OHRS.
The ADMR may review research protocols that are submitted to OHRS, including amendments, eligibility exceptions, deviations, violations as well as serious adverse events and conduct initial medical review in anticipation of scientific review or institutional review board review.
The ADMR participates in meetings with Senior Officials of all of the Dana-Farber/Harvard Cancer Center on issues relating to the review, approval and oversight of cancer research involving human subjects. The ADMR also serves as a liaison to study teams in that the ADMR communicates with study teams after scientific review committee meetings and meets with study teams in order to assist in improving the quality of protocol submissions.
The ADMR is also responsible for working together collaboratively with the other OHRS senior staff in managing situations involving non-compliance; subject complaints; AAHRPP accreditation; HHS and FDA IRB audits; FDA audits of investigators; and other similar regulatory and substantive activities.
Be familiar with the requirements of the NCI Cancer Center Support Grant (CCSG) and the operations of the Scientific Review Committees (SRC).
Communicate on a regular basis with the Chairs of the SRC committees to ensure consistency and appropriate consideration of issues impacting scientific review.
Review protocol submissions as well as other protocol related events from a medical perspective in order to provide assistance to the SRCs and IRBs.
Work with study teams as needed to improve the quality of protocol submissions.
Develop policy documents relating to medical issues with clinical and non-clinical research.
Represent, as necessary, the OHRS at meetings of the DF/HCC including the Clinical Operations Subcommittee of the Clinical Investigations Committee, DF/HCC
Liaison with Regulatory Groups including Cooperative Groups and CTEP at the National Cancer Institute
Participate in the review of compliance issues including the reporting of government required reporting events to FDA and OHRP
Participate in the management of responses to research subject complaints
Representation of OHRS at outside conferences and meeting
The ADMR may serve as the Acting Director of the OHRS when the Director and Associate Director are out of the office.
The ADMR as the Acting Director has the authority to make decisions that can be made by the Director.
The ADMR helps to oversee the work of Human Research Coordinators, but will not have direct supervisory responsibility.
At least five years of practice is required after completion of degree; oncology experience is highly preferred.
Experience serving on an institutional review board is highly preferred.
KNOWLEDGE, SKILLS, AND ABILITIES REQUIRED:
Ability to problem solve
Strong oral and written skills
Ability to analyze
Ability to manage staff
Strong interpersonal skills to interact with individuals from a variety of institutions
This is a position that involves working in an office; at a computer; on the phone, etc. Regular travel to Main Campus from Fenway/Brookline Village Area (0.5 – 0.8 miles each way) is required. A free shuttle bus is available between these locations.
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.