Regulatory Analyst - 138730

The Department of Medicine is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego and employs 486+ full-time salaried faculty members and 100+ academic appointees. Staff personnel include 600+ staff in 9 bargaining units, students, and volunteers. There are 250 clinical faculty practicing at multiple sites and hospitals.

Under the supervision of the Adm Vice Chair of Cardiovascular Clinical Research, research supervisors, and the division chief, this key professional position is responsible for independent handling and preparation of the regulatory documents, oversight of regulatory compliance, project analysis, report compilation for various internal and external information systems and sources of the cardiovascular research team in the Division of Cardiovascular Medicine, in the Department of Medicine. The Cardiovascular Research team works with several different funding agencies performing over 100 distinct clinical trials through various clinical trials contracts and multi-million dollar NIH/DOD grants. This position requires demonstrated in-depth knowledge of University of California (UC), Health Insurance Portability and Accountability Act (HIPAA), Food and Drug Administration (FDA), Office for Human Research Protections (OHRP), International regulations pertinent to clinical research with a strong emphasis in regulatory submissions to include human subject protections, subject consent and diverse Institutional Review Board (IRB) policies applicable at the various domestic and international clinical sites. In addition, this position requires a demonstrated working knowledge of medical terminology and scientific/biological procedures, Conflict of Interest, Good Clinical Practices (GCP), federal research regulations and requirements, clinical trials administration and regulatory monitoring. This individual serves as a subject matter expert and as a resource reviewer for clinical trials, investigator-initiated studies, and grant supported research interpreting regulations for the cardiovascular medicine faculty, PI's and administrative staff by maintaining up to date knowledge of local, state federal and International regulations as well as Office of IRB Administration (Human Research Protections Program (HRPP)) and relevant Commercial/Central Institutional Review Boards related policies and procedures regarding the protection of human subjects. The incumbent will create subject consent forms and independently reviews and analyzes proposed informed consent documents for consortium participating UC and external sites; assists in the development, review and distribution of study set-up materials including, but not limited to, subject consent forms, clinical study protocols and regulatory packages. In addition to managing UCSD's IRB submissions and renewals, will interface and serve as liaison with the cardiovascular medicine clinicians and commercial/central IRBs (i.e:WCG) to ensure proper study submission and timely protocol approval. Produces impactful, concise, descriptive written reports summarizing analysis results and recommendations, suitable for external advisory board briefings. Conducts difficult negotiations with PI's and the IRB and/or other appropriate bodies (such as office of coverage analysis administration), representing the final determinations in an appropriate manner.

Collaborating with Adm Vice Chair, Research supervisors as well as clinical trial committee for approval of new trials. Oversees Coordination of multiple clinical trials of novel interventional products (drug and device) at any given time. Works collaboratively with outside affiliates, represents the division both internally and externally, and identifies barriers (regulatory and compliance) to successful clinical trials execution and fosters approaches towards reducing barriers. The incumbent will assist with coordination of activities among functional research groups in the division of Cardiovascular Medicine. Responsible for development and revision of clinical SOP's and guidelines to ensure adherence to applicable ethical, regulatory and clinical standards. Provides input to clinical operations portion of proposals, budgets, contracts, and standard of care.

Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization, policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and people outside the University. Interactions 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. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participant at undo risk and / or compromise the institution's assurance of regulatory compliance with the federal government. Initiates study start up activities for the Cardiovascular Research Center including completion of regulatory documents, local and central IRB submissions and COIs. Additionally, works with Adm. Vice Chair of Cardiovascular Clinical Research and supervisors in identifying research coordinators for specific studies. Initiates and completes VELOS and EPIC Research applications for studies. Works closely with the supervisors in the research team providing timely updates on study start up progress.

• Seven years of related experience, education/training, OR an Bachelor's degree in related area plus three years of related experience/training.

• Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. Demonstrated experience working with FDA regulations, UC & HRPP policies and procedures, Good Clinical Practice guidelines and other regulations for the conduct of clinical research with a strong emphasis in human subject protections.

• Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology.

• Thorough knowledge of clinical trials components including study methodology, informed consent; eligibility; adverse events. Demonstrated success and skill at researching, analyzing and evaluating information for preparation of clinical research protocols.

• Demonstrated extensive knowledge of OHRP and HIPAA regulations as well as other regulatory agencies pertinent to clinical research.

• Demonstrated self-discipline and sound, independent judgment completing complex assignments. Demonstrated ability to make independent decisions, analyze situations, solve problems, and initiate actions for the effective management of a large and complex workload. Strong analytical and critical thinking skills to identify problems and develop innovative solutions.

• Demonstrated proficiency in public speaking, and writing.

• Conflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interest.

• Strong computer skills and demonstrated knowledge of a variety of software programs (email, word processing, spreadsheet, database applications, Adobe Acrobat, web browsers, etc.). Ability and willingness to learn new software as needed.

• Strong organizational skills and ability to manage multiple projects with conflicting deadlines and priorities. Ability to meet deadlines. Ability to work with minimal direction and on a self-directed basis as well as in a team setting.

• Superior interpersonal, written and oral communication skills to effectively communicate, collaborate, establish and maintain good working relationships with a diverse population encompassing multi-disciplinary researchers, faculty and staff about complex research issues. Demonstrated ability to communicate with tact, diplomacy, flexibility, professionalism, and discretion.

• Demonstrated ability to appropriately handle highly sensitive and confidential situations and matters with faculty and staff.

• Relevant compliance certification (if applicable) preferred.

• Employment is subject to a criminal background check.