Principle Research Compliance Specialist - 138759

The Altman Clinical and Translational Research Institute (ACTRI) is an NIH-funded Clinical and Translational Science Award (CTSA) institution that provides the infrastructure to support high-quality and innovative translational research. ACTRI's vision is to translate scientific discoveries into improved health by delivering education, training, and infrastructure for clinical research in the San Diego area and beyond. Mike Hogarth, M.D. and Davey Smith M.D. are the principal investigators on ACTRI's CTSA grant. The ACTRI functions under the direction of Dr. Smith, M.D., Director and Assistant Vice Chancellor of Clinical and Translational Research at UC San Diego.

Under general direction the incumbent serves as a Principle Research Compliance Specialist and an ACTRI liaison for UC San Diego investigators seeking study initiation and regulatory support services. This role also serves as a key point of contact for investigators from ACTRI partner organizations. The incumbent provides highly complex analytical, regulatory, and administrative support to investigators. Responsibilities include conducting independent, in-depth reviews of administrative and regulatory submissions such as protocol amendments, master protocols from sponsors, Investigator Brochures, informed consent documents, and related regulatory materials to ensure compliance with federal, state, and institutional requirements as well as preparation of IND/IDE and pre-meeting submissions to the FDA.

As a subject matter expert in human subjects research compliance, the incumbent independently interprets and applies federal regulations, UC policy, and institutional guidance, and serves as a trusted resource for Principal Investigators, research teams, study staff, and other stakeholders. The role includes providing training, consultation, and education related to the ethical conduct of human subjects research and the protection of research participants, guided by HHS-OHRP, FDA, HIPAA, and UC/UC San Diego policies.

The position requires the use of advanced professional judgment and discretion, applying seasoned project management and regulatory expertise to complex and high-risk research portfolios. The incumbent demonstrates in-depth knowledge of clinical trials administration, regulatory monitoring, and compliance oversight, Good Clinical Practice (GCP), conflict of interest requirements, and sponsor-initiated and investigator-initiated clinical research.

This front-line role independently prepares, reviews, and manages regulatory documentation for a broad range of studies, from small investigator-initiated projects to large, multi-center and industry-sponsored clinical trials. The incumbent interacts frequently with faculty investigators, senior research and administrative leadership, institutional partners, and external entities such as industry sponsors and regulatory agencies. These interactions require a high level of tact, diplomacy, and independent judgment, as well as the ability to advise and counsel stakeholders on complex regulatory and compliance issues.

Uses advanced research compliance concepts to interpret highly complex and broad regulations, policies and guidelines. Regularly works on highly complex research compliance issues where analysis requires an in-depth evaluation of variable factors. Exercises judgment in selecting methods, techniques and evaluation criteria to anticipate and identify problems and develop and implement the appropriate response and / or action. Serves as a technical expert and advisor to department head.

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

• Demonstrated self-discipline and independent judgment completing highly complex, broadly defined assignments.

• Advanced knowledge and ability to apply all relevant Federal, state, and university regulations policies, and federal guidance documents.

• Advanced knowledge of quantitative and qualitative research design, scientific research concepts and terminology.

• Strong proficiency in public speaking, and writing. The ability to work collaboratively across diverse units.

• Knowledge of federal, state, and institutional regulations governing human subjects research.

• Proven ability to evaluate complex regulatory issues and develop solutions using independent judgment.

• Experience supporting FDA submissions such as IND, IDE, and 510(k), including pre submission documentation.

• Expertise in HHS OHRP, FDA, HIPAA, GCP, IND/IDE processes, and clinical research regulatory requirements.

• Employment is subject to a criminal background check.

• Occasional evenings and weekends may be required.