JOB OVERVIEW Advancing New Standards in Reproductive Health (ANSIRH) is seeking an Compliance Manager to manage all aspects of Institutional Review Board (IRB) and Food and Drug Administration (FDA) Investigational New Drug (IND) compliance for multiple studies related to the alternative provision of medication abortion, the impact of policies on women’s access to and experiences with abortion, and the impact of other state reproductive health policies. The Compliance Manager will use her/his skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies and procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices for a series of studies.
We seek candidates with experience in the following areas: 1. Compliance: writing and reviewing IRB applications, a deep understanding of human subjects protections and best practices; applying for, monitoring and reporting on FDA INDs; conducting study close-out activities assuring adherence to best practices and compliance with regulations. 2. Data management: developing, updating and revising study protocols and study documents; developing study-related materials; developing and implementing best practices for data montoring, data retention, and data destruction.
The Compliance Manager will work as part of the Alternative Provision of Medication Abortion team at ANSIRH. In this role, s/he will interact frequently with investigators and research staff at other collaborating institutions. Interactions with outside collaborators will require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Candidates for this position should demonstrate good judgment in selecting methods and techniques for obtaining solutions to complex compliance issues. Errors or omissions may ultimately place research participants at undo risk and / or compromise the institution's assurance of regulatory compliance with the federal government. Experience with juggling multiple tasks and a track record of adhering to deadlines are also required. Comfort working in an environment in which abortion is discussed frequently is essential.
Please note: This is a full time 12 month contract position starting from the date of hire. Work location – Oakland, CA.
ANSIRH / BIXBY CENTER FOR GLOBAL REPRODUCTIVE HEALTH ANSIRH ANSIRH is a collaborative research group at UCSF and a program of the Bixby Center for Global Reproductive Health. We are committed to integrity, collaboration, innovation, cultivation, and justice, and that means building and supporting a diverse and inclusive workplace. We are an equal opportunity employer and we recruit and hire with understanding of the lived realities of people who have experienced system oppression. We envision a world in which all people have the resources, support, and freedom to achieve reproductive well-being. That is why we strive to invest in the overall well-being of our employees. Visit www.ansirh.org for more about our vision and mission.
As UCSF employees, ANSIRH faculty and staff have access to a comprehensive benefits package (retirement, health, dental, commuter, etc.), as well professional development opportunities, wellness programs, and many other benefits (https://ucnet.universityofcalifornia.edu/working-at-uc/index.html). In addition, ANSIRH prioritizes continuous learning, work-life balance, and employee engagement.
ANSIRH is part of the Bixby Center for Global Reproductive Health at UCSF, a multi-disciplinary academic center focused on the most pressing need for adolescent sexual health, family planning, abortion policy, maternal health and sexually transmitted infections.
OBSTETRICS, GYNECOLOGY & REPRODUCTIVE SCIENCE The Department of Obstetrics, Gynecology and Reproductive Sciences (Ob/Gyn & RS) is a major academic Department in the School of Medicine, engaged in clinical, research, and training activities at the Parnassus, Mt. Zion and San Francisco General Hospital (SFGH) campuses, as well as satellite locations throughout the Bay Area, with an annual operating budget of $77.2 million and the new Betty Irene Moore Women’s Hospital at Mission Bay. The OBGYN Department has 102 full-time faculty, 136 other academic appointees, 39 post-doctoral fellows, 20 clinical fellows, 36 residents, 136 voluntary clinical faculty, and 266 staff. The mission of the UCSF Department of OBGYN & Reproductive Sciences is to improve the lives and health of all women through excellence, innovation and leadership in Patient Care, Scientific Discovery, Education, Advocacy. “Leading the way in women’s health.”
ABOUT UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences.
* Bachelor's degree in any field and / or equivalent experience / training * Three to five years of professional experience or relevant combination of education and experience * At least two years’ experience writing or reviewing Institutional Review Board (IRB) applications * Thorough knowledge and ability to apply all relevant Federal, state, and/or university regulations, policies, and federal guidance documents * Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology * Demonstrated self-discipline and sound, independent judgment completing complex assignments and adhering to deadlines * Complete comfort working in an environment in which abortion is frequently discussed * Ability to manage multiple projects simultaneously and to prioritize tasks * Ability to work independently and as part of a team * Excellent attention to detail
* Master’s degree in research administration, public health, or related area * Relevant compliance certification (if applicable) * Experience with UCSF policies and procedures and research administration, including UCSF IRB, MyResearch and REDCap * Experience using STATA to clean data or run basic analyses * Experience with study close out and data destruction * Familiarity with FDA IND regulations and procedures
The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information.