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Senior IRB/SRC Analyst
2 months ago
The work location for this position is full remote however the selected candidate must live and work from one of the New England states (ME, NH, VT, MA, RI, CT) Located within the Office for Human Research Studies (OHRS), the IRB/SRC Analyst job family is critical to the review and approval of research studies involving human subjects at Dana-Farber/Harvard Cancer Center. These roles implement and coordinate the daily activities of the IRB/SRC and analyze all submissions for completeness, accuracy, ethical and regulatory compliance. Reporting to an Associate Director or Director, the Senior IRB/SRC Analyst is responsible for the supervision of OHRS staff. This role also communicates and interacts extensively with research associates, support staff, principal investigators, Scientific Review Committee members, and institutional leadership. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals. Manage two or more Scientific Review Committee panels including supervision of other OHRS staff who conduct scientific and statistical reviews, manage the flow during the meeting, create or supervise outcome letters, and manage new protocols and amendments submitted to their SRC panel. Work closely with SRC Chairs, SRC panel members, and investigators regarding the protocols under review at each meeting. Work with the Protocol Review and Monitoring System within the research administration platform to ensure transparency of all reviews, comments and data relevant to SRC and IRB oversight. Serve as an SRC expdited reviewer with the ability to approve certain types of protocol submissions eligible for expedited SRC review. Assist OHRS Leadership in identifying areas for enhancement to increase efficiency and compliance, as well as recommending proposed solutions. Independently prepare pre-review comments of protocol submissions and informed consent documents in anticipation of SRC 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. Independently write clear, concise and timely SRC/IRB minutes or edit minutes drafted by other IRB/SRC Analysts. 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 SRC Analysts. Train new IRB/SRC Analysts and support their advancement and growth. Answer questions of IRB/SRC members independently. Participate in the annual evaluation of IRB and SRC members. Report to OHRS Leadership performance issues and concerns regarding SRC Analyst work product and work distribution. Coach and evaluate SRC analysts and make recommendations for promotion. Independently manage special projects as assigned. Actively lead an internal OHRS committee and/or workgroup. 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 major OHRS projects or programs. Perform other duties as assigned by the Associate Director or Director. SUPERVISORY RESPONSIBILITIES: Directly supervises small group of protocol management focused IRB/SRC Analysts I - IV. Bachelor’s degree required; Advanced degree in a relevant field preferred (e.g., PhD, MPH, JD). 5 years of experience working in the research field or research oversight, some experience in SRC or IRB offices prefered; 3 years of experience with advanced degree in a relevant field. Experience with federal, state, and local regulations and guidance regarding the protection of human subjects in biomedical and behavioral research required for IRB Analysts. Certified IRB Professional (CIP) required within 2 years without an advanced degree for IRB Analysts. At Dana-Farber Cancer Institute, we work every day to create an innovative, caring, and inclusive environment where every patient, family, and staff member feels they belong. As relentless as we are in our mission to reduce the burden of cancer for all, we are equally committed to diversifying our faculty and staff. Cancer knows no boundaries and when it comes to hiring the most dedicated and diverse professionals, neither do we. If working in this kind of organization inspires you, we encourage you to apply. 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 characteristics protected by law. EEOC Poster #LI-SJ1
