111513 - Sr. Clinical Trials Regulatory Research Specialist
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#111513 Sr. Clinical Trials Regulatory Research SpecialistExtended Deadline: Wed 9/29/2021
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus before they will be allowed on campus or in a facility or office. For more information visit: https://ucnet.universityofcalifornia.edu/news/2021/07/ucs-covid-19-vaccine-policy.html
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 09/07/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 09/15/21. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Clinical Trials Office (CTO) at the Moores UCSD Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators. Reporting to the CTO Administrative Director, the Sr. Clinical Trials Regulatory Research Specialist is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center that require submissions to the Food and Drug Administration (FDA). Key to this role is the development and preparation of clinical trial protocols and related regulatory documents for submission to the FDA and to the UCSD Human Research Protections Program (UCSD's Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed.
The Regulatory Research Specialist will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, UCSD IRB, and the CTO. This position requires regular interaction with FDA and a variety of internal and external contacts including Cancer Center investigators and staff, UCSD IRB staff, study sponsors and/or their representatives. Additional responsibilities include making significant contributions to protocol development which consists of two principal functions: (1) Develop clinical protocols in support of the clinical research mission of the Cancer Center and (2) Work with the CTO Executive Director and CTO Administrative Director to provide scientific and regulatory advice to physician scientists. The position will be responsible for the filing with the FDA of necessary documents, including investigational New Drug (IND), Investigational Device Exemptions (IDE) and New Drug Applications (NDA).
Theoretical knowledge in a biological science as typically attained by a Bachelor's degree and/or equivalent education and experience. Knowledge of medical and pharmaceutical terminology and concepts, and/or of biological science, sufficient to understand the contents of medical research protocols and research processes.
Experience with regulatory issues in clinical research. Direct experience with FDA, NCI, and ICH regulations and guidelines for clinical studies and medical devices, including GCP’s and GMP’s. Knowledge of compliance issues and proven experience in adherence counseling techniques. Knowledge of Federal and University polices on clinical trials and protection of human subjects.
Knowledge of clinical trials components including statistics, study methodology, informed consent; eligibility; adverse events. Demonstrated success and skill at researching, analyzing and evaluating information for preparation of clinical research protocols.
Knowledge of FDA regulations, Institutional Biosafety Committee policy and NIH guidelines as they relate to Investigator Initiated Trials (IIT).
Demonstrated experience filing Investigational New Drug (IND) Applications to FDA
Demonstrated experience filing Investigational Device Exemptions (IDE) to the FDA.
Extensive knowledge writing and submitting Annual Safety Reports to the FDA.
Ability to lead other clinical research specialists to support the growing needs of the cancer center investigators that are performing Investigational New Drug (IND) studies.
Experience in data collection, management and analysis, using web tools, relational databases, statistical software and spreadsheets.
Knowledge of national and international trends in research and experience with clinical research programs.
Thorough understanding of auditing processes in the drug development and approval process. In-depth knowledge and understanding of complex audits that require interpreting regulations, guidelines, and compliance issues. Experience in developing, implementing, evaluating, and documenting audit procedures.
Experience in developing long-term goals, initiatives, plans and programs and evaluating accomplishments. Ability to develop, analyze, and carry out program and project objectives and work with others in achieving organizational goals. Ability to research, gather and organize information to produce clear and concise reports and presentations using various resources.
Work experience in planning, implementing and evaluating clinical research studies and writing and submitting clinical trials protocols. Industry experience preferred.
Substantial experience in performing complex analyses on policies and programs, policies and procedures relating to clinical research.
Significant experience writing about science for both technical reviewers and the public as well as writing clinical trials protocols for review committees and regulatory agencies including the National Institutes of Health (NIH).
Extensive knowledge of the Code of Federal Regulations that pertain to new drug development.
Strong skill in written communications that express complex medical, scientific, and/or technical content in understandable terms. Experienced in proofreading, editing for content, style, flow and tone. Ability to write concise, logical, grammatically correct analytical or narrative reports. Ability to develop reports and oral presentations.
Proficient skill is software applications, specifically spreadsheet, word processing and database applications. Knowledge of and experience with clinical database development and data management.
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.
Sound understanding of the role of clinical research in a major research university and its links with campus, national and international constituencies and industry.
- Bachelor's degree.
- Knowledge of cancer research and/or management of oncology clinical research trials and clinical trial protocol development experience.
- Employment is subject to a criminal background check and pre-employment physical.
- Ability and willingness to travel on occasion (<5%).
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health is the only academic health system in the San Diego region, providing leading-edge care in patient care, biomedical research, education, and community service. Our facilities include two university hospitals, a National Cancer Institute-designated Comprehensive Cancer Center, Shiley Eye Institute, Sulpizio Cardiovascular Center, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic team!
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