Senior Research Compliance Analyst
17 hours ago
We are seeking a highly skilled and experienced Senior IRB/SRC Analyst to join our team at Dana-Farber Cancer Institute. As a key member of our Office for Human Research Studies (OHRS), you will play a critical role in the review and approval of research studies involving human subjects.
Key Responsibilities- Manage two or more Scientific Review Committee panels, including supervision of other OHRS staff who conduct scientific and statistical reviews.
- Work closely with SRC Chairs, SRC panel members, and investigators regarding protocols under review at each meeting.
- Ensure transparency of all reviews, comments, and data relevant to SRC and IRB oversight using the Protocol Review and Monitoring System.
- Serve as an SRC expedited 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, referring 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, and report performance issues and concerns regarding SRC Analyst work product and work distribution to OHRS Leadership.
- Independently manage special projects as assigned, actively lead an internal OHRS committee and/or workgroup, and conduct training sessions within the DF/HCC community.
- Facilitate meetings with DF/HCC research personnel and occasionally represent OHRS at DF/HCC meetings, including DSMC, Audit Committee, and ClinOps.
- Provide support to major OHRS projects or programs and perform other duties as assigned by the Associate Director or Director.
- Bachelor's degree required; advanced degree in a relevant field preferred.
- 5 years of experience working in the research field or research oversight, with some experience in SRC or IRB offices preferred.
- 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.
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, educate tomorrow's physician/researchers, and work with amazing partners, including other Harvard Medical School-affiliated hospitals.
We are an equal opportunity employer and affirm 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.
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