Clinical Trials Research Monitor (86436) University of California San Diego School of Medicine
This position will remain open until a successful candidate has been identified.
DESCRIPTION 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 Research Monitor will coordinate all aspects of the clinical monitoring process in accordance with Federal Regulations, Good Clinical Practice (GCP), NCI and UCSD SOPs. The Clinical Trials Research Monitor will be responsible for conducting internal audits of non-industry funded therapeutic oncology trials managed through the Clinical Trials Office at the Moores UCSD Cancer Center (MCC); conducting site visits to determine protocol and regulatory compliance and prepare required documentation; participating in the study development and start-up process including reviewing clinical research protocols, designing CRFs, preparing Informed Consent Forms, developing study documents and working with investigators and DSMB on the trial monitoring strategy.
Trials to be monitored on a regular basis predominately include therapeutic intervention trials, sponsored by national cooperative groups, conducted both at MCC and the 5 affiliate CALGB centers. Travel to affiliate sites require an average of 5 times a year to each center to conduct clinical monitoring visits. Clinical Research Monitoring includes but is not limited to reviewing data collection for accuracy and completeness, training and leading clinical research personnel at centers in protocol procedures and implementation, identifying problems in protocol implementation and conduct, and review/resolution of regulatory issues. Additional responsibilities may include involvement with the development and maintenance of MCC electronic data capture (EDC) systems and monitoring of therapeutic oncology investigator-initiated trial (IIT) data.
MINIMUM QUALIFICATIONS • Theoretical knowledge and/or a Bachelor's Degree in Life Sciences field, with strong emphasis on medical terminology and/or research methodology; and/or equivalent education and work experience. • Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research. • Demonstrated experience working with GCPs-FDA policies governing clinical trials and regulatory site activities. • Strong knowledge and experience working within ICH, GCP, NIH, state and federal guidelines. • Experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians. • Demonstrated experience in medical assessment and patient interviewing to determine patient eligibility and toxicities. • Experience in monitoring protocol non–compliant situations and developing action plans specific to or in response to inspection and audit reports. • Experience managing various monitoring activities, site initiations, site qualifications, informed consent process, protocol compliance, and audit preparedness. • Experience verifying data sources in clinical trials research, as well as verifying study eligibility criteria and protocol compliance. • Excellent interpersonal skills including tact, diplomacy and flexibility with the ability to work in a team framework in conjunction with principles of community with supervision, staff, professionals, the public, and others. • Ability to lead and/or participate in discussions regarding procedures and goals of unit. Must be able to maintain strict confidentiality.
PREFERRED QUALIFICATIONS • Minimum two (2) years of experience with clinical research in therapeutic oncology trials.
SPECIAL CONDITIONS • Must be able to obtain pre-employment background check clearance, physical clearance and TB test clearance. • Must be able to obtain annual TB/Fit test clearances. • Must be available to work occasional evenings and weekends as needed. • Must be willing to travel up to 15% of the time as needed.
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. U.S. News and World Report's annual "America's Best Hospitals" report has repeatedly ranked UC San Diego Health as the #1 health system in San Diego. We invite you to join our dynamic team!
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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