UC San Diego Jobs Site

Column Content Left
New Jobs
105 of 113 Positions

#95638 Clinical Trials Research Monitor

Extended Deadline: Mon 12/17/2018

This position will remain open until a successful candidate has been identified.

UCSD Layoff from Career Appointment: Apply by 09/24/18 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.

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. 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 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. Experience working with GCPs-FDA policies governing clinical trials and regulatory site activities.

  • Demonstrated experience in monitoring protocol non–compliant situations and developing action plans specific to or in response to inspection and audit reports.

  • Proven experience managing various monitoring activities, site initiations, site qualifications, informed consent process, protocol compliance, and audit preparedness.

  • 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.

  • Working knowledge of medical oncology terminology and concepts sufficient to review and understand the contents of oncology/hematology research protocols and amendments. Working knowledge and experience with drug terminology and its use.

  • Experience verifying data sources in clinical trials research, as well as verifying study eligibility criteria and protocol compliance. Strong knowledge and experience working within ICH, GCP, NIH, state and federal guidelines.

  • Demonstrated experience submitting deviation reports regarding non-compliance issues. Experience working with NIH, FDA, IBC guidelines and requirements.

  • Demonstrated ability to perform project management including: planning, organizing, leading and controlling aspects for successful project completion.

  • Ability to create control systems to identify areas for improvement, control unforeseen problems, and lead a team to successful project completion. Proven ability to create monitoring tools.

  • Strong computer skills and proficiency in Windows, Mac OS, MS Word, Excel, Access, PowerPoint, Adobe Illustrator, Photoshop, and a variety of web-based programs.

  • Excellent record keeping and data management skills with demonstrated ability to obtain and record accurate information and details to insure proper completion of forms and reports.

  • Ability to train other monitors and study personnel on-site, review of collected data, and provide adequate feedback to site personnel.

  • Must be able to maintain strict confidentiality.

PREFERRED QUALIFICATIONS

  • Minimum of two (2) years of clinical research experience in therapeutic oncology trials.

SPECIAL CONDITIONS

  • Employment is subject to a criminal background check and pre-employment physical.

  • 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. 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:
CLIN RSCH CRD AST
Department:
CANCER CENTER/Clinical Trials Office
Salary Range
Commensurate with Experience
Worksite:
Moores Cancer Center
Appointment Type:
Career
Appointment Percent:
100%
Union:
RX Contract
Total Openings:
1
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.