Regulatory Specialist - 138619

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 minimal supervision, incumbent will assist in study initiation and provide regulatory services including administrative support that includes submission of initial clinical research applications, amendments and renewals to the Institutional Review Boards as well as maintenance of regulatory documentation, working with study sponsors/CROs as well as working with related, collaborating University offices such as Radiation Safety, Biosafety, Conflict of Interest Office (COI), Office of Coverage Analysis (OCAA) and Office of Clinical Trials Administration (OCTA) and external regulatory offices such as independent IRBs. In general, this individual must work independently with minimal supervision or oversight for routine or standard assignments.

Incumbent will maintain and continuously update their knowledge of HHS-OHRP, FDA, HIPAA regulations as well as Good Clinical Practices (GCP). Knowledgeable about clinical trials administration and regulatory monitoring. This front line position will generate regulatory documents for investigators requesting ACTRI services from small investigator-initiated projects to large multi-center clinical trials. Interacts frequently with investigators, persons in other organizational departments, as well as with persons outside the University such as industry- sponsor personnel. Interactions require the use of tact and independent judgment, knowledge of standards and best practices. Demonstrate good judgment in selecting methods and techniques for obtaining solutions.

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 occasionally persons 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.

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

• 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.

• 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.

• Demonstrated proficiency in public speaking, and writing.

• 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.

• Demonstrated experience in planning, implementing and evaluating clinical research studies and writing and submitting clinical trials protocols.

• Demonstrated skill in written communications that express complex medical, scientific, and/or technical content in understandable terms. Experience proofreading, editing for content, style, flow and tone. Demonstrated ability to write concise, logical, grammatically correct analytical or narrative reports.

• Strong 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.

• Understanding of the role of clinical research in a major research university and its links with campus, national and international constituencies and industry.

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

• Must be able to maintain confidentiality.

• Must be able to travel to different locations.

• Employment is subject to a criminal background check.

• Occasional evenings and weekends may be required.