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#97591 Clinical Research IND/FDA Specialist

Initial Review Date: Tue 2/19/2019

This position is open to external applicants as of 2/6/19 and will remain open until a successful candidate has been identified.

UCSD Layoff from Career Appointment: Apply by 1/24/19 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.

Special Selection Applicants: Apply by 1/25/19. Eligible Special Selection clients should contact their Disability Counselor for assistance.

DESCRIPTION

The Moores Cancer Center is one of just 49 in the United States to hold a National Cancer Institute (NCI) designation as a Comprehensive Cancer Center. As such, it ranks among the top centers in the nation conducting basic and clinical cancer research, providing advanced patient care and serving the community through outreach and education programs. The Cancer Center's mission is to translate promising scientific discoveries into new and better options for the care of patients with cancer. The Center supports one of the broadest ranges of cancer activities in the nation – from fundamental and translational cancer research in molecular genetics and advanced molecular therapeutics, and from population studies of cancer incidence to community education about cancer prevention and risk reduction.

The Clinical Trials Office (CTO) at the Moores UCSD Cancer Center manages over 300 oncology clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators. 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.

Under the direction of the Associate Director, this position provides complex analytical and administrative support to the UCSD Human Research Protections Programs, Institutional Review Boards (Biomedical and/or Social and Behavioral) and related collaborating University and external regulatory offices in support of research conducted under reliance agreements between UCSD and the FDA.

As the subject matter expert serves as a resource and is responsible for interpretation of policy and providing training and education to faculty (MDs, PhDs), Principal Investigators, researchers, study staff, students, human subjects (study participants) and other individuals regarding the protection of human subjects in research compliance guided by Federal, and other regulatory agencies, UC policy and public perception regarding human subjects research across VCHS, and UCSD. Responsible for identifying significant campus issues and incorporate findings into outgoing communications to researchers advising the IRB and the PIs of the IRB's deliberation and actions.

MINIMUM QUALIFICATIONS

  • Bachelor's degree in related area and/or equivalent experience/training.

  • Three or more years of relevant experience.

  • Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents. These include federal, state and local regulations and policies including DHHS, HHS-OHRP regulation, FDA regulations for the use of investigational drugs, biologics and devices; California law on human experimentation, other compliance agencies or directives, and university policy regarding human subject research.

  • Thorough knowledge to properly review research proposals, request necessary additional information from researchers prior to review of adverse events or possible violations of human subject protection policy, to evaluate actions taken by investigators in response to committee requests, and to audit and ensure compliance with the approved protocols

  • Expertise in clinical trials, investigator-initiated studies, and grant-supported research or related areas. Thorough knowledge of the academic research and medical/scientific terminology and demonstrated ability to comprehend the research process and the various components.

  • 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 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.

  • Thorough 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. Extensive knowledge of the Code of Federal Regulations that pertain to new drug development.

  • Proven experience to manage multiple HRPP related committees (IRB, ESCRO, Oncology etc.) effectively or demonstrated involvement in facilitating and coordinating committees.

  • Demonstrated strong project management experience.

SPECIAL CONDITIONS

  • Employment is subject to a criminal background check.

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!

 

Applications/Resumes are accepted for current job openings only. For full consideration on any job, applications must be received prior to the initial closing date. If a job has an extended deadline, applications/resumes will be considered during the extension period; however, a job may be filled before the extended date is reached.

 

UC San Diego Health is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, age, protected veteran status, gender identity or sexual orientation. For the complete University of California nondiscrimination and affirmative action policy see: http://www-hr.ucsd.edu/saa/nondiscr.html

UC San Diego is a smoke and tobacco free environment. Please visit smokefree.ucsd.edu for more information.

UC San Diego School of Medicine
Payroll Title:
RSCH CMPLNC ANL 3
Department:
CANCER CENTER
Salary Range
Commensurate with Experience
Worksite:
Moores Cancer Center
Appointment Type:
Career
Appointment Percent:
100%
Union:
Uncovered
Total Openings:
2
Work Schedule:
Days, 8 hrs/day, Monday-Friday

 

As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.