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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 Protocol Development Specialist of the Moores UCSD Cancer Center Clinical Trials Office has two major responsibilities: develop clinical trial protocols in support of the clinical research mission of the Cancer Center and provide scientific and regulatory advice to physician scientists. The Protocol Development Specialist will be the senior scientific specialist of the CTO, skilled in the preparation of cancer clinical trial protocols; knowledgeable about PHS, FDA and UCSD regulatory requirements; and able to mobilize physicians and industry to initiate new trials at the Moores UCSD Cancer Center. The Protocol Development Specialist will work in the regulatory section of the CTO, being responsible for the development, submission and approval of protocols through the PRMC/IRB review process. Additionally, the Protocol Development Specialist will work with the CTO Executive Director, CTO Assistant Director, CTO IIT regulatory specialists, CTO Project Managers, and physician scientists. The position will be responsible for the filing with the FDA of necessary documents, including IND, NDA and SAE reports. The goal of this position is to expand the opportunities for advanced therapeutics and the number of cancer patients on trials. Consequently, the individual will be involved in every aspect of clinical trials development, implementation and reporting. The Protocol Development Manager will primarily collaborate with the Protocol Development Advisor, IIT regulatory specialist and physician scientists to ensure high quality and quantity trials support.
Strong theoretical knowledge in a biological science, plus experience in protocol development or an equivalent combination of education and experience. Advanced degree preferred.
Demonstrated ability to identify potential sources for program development as well as the ability to prepare appropriate proposals.
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.
Sound understanding of the role of clinical research in a major research university and its links with campus, national and international constituencies and industry.
Thorough knowledge of clinical trials methodology and oncology. Experience in research techniques such as following protocols and in collecting all data precisely.
Experience in developing long-term goals, initiatives, plans and programs and evaluating accomplishments. Proven 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.
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.
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).
Experience in data collection, management and analysis, using web tools, relational databases, statistical software and spreadsheets.
Experience in maintaining quality control in clinical research activities. Working knowledge of auditing processes in the drug development and approval process. Working knowledge and understanding of complex audits that require interpreting regulations, guidelines, and compliance issues. Experience in developing, implementing, evaluating, and documenting audit procedures.
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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