This position will remain open until a successful candidate has been identified.
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.
UCSD Layoff from Career Appointment: Apply by 02/13/17 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor. Eligible Disability Counseling and Consulting services (DCC) or Special Selection clients should contact their Vocational Rehabilitation Counselor for assistance.
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.
Minimum two (2) years of experience with clinical research in therapeutic oncology trials.
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 is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and ...five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.