Clinical Research Coordinator - 116827
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#116827 Clinical Research CoordinatorFiling Deadline: Tue 7/12/2022
For the safety and well-being of the entire university community, the University of California requires, with few exceptions, that all students, faculty and staff be vaccinated against the COVID-19 virus and influenza before they will be allowed on campus or in a facility or office. For more information visit: Flu Vaccine Mandate / COVID Vaccine Policy
UCSD Layoff from Career Appointment: Apply by 06/08/22 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 06/20/22. Eligible Special Selection clients should contact their Disability Counselor for assistance.
Responsible for coordinating and managing clinical trials/observational/epidemiological/data collection/investigator initiated studies including providing all aspects of protocol management/interaction with patients, screening for patient eligibility, recruitment and subject enrollment, data collection and entry into electronic case report forms, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, interacting with monitors, preparing for possible audits, and maintenance of accurate and complete regulatory files. Will assist with study startup and also do human subjects submissions to IRB, renewals, amendments and safety reports, directly communicate with assigned physicians, draft SOPs, assist with biobank sample collection and management, and perform other duties as necessary.
Theoretical knowledge of biology, microbiology, social sciences, clinical sciences as typically attained by a Bachelor's degree, or an equivalent combination of education and experience.
Experience performing clinical research duties in a clinical research environment.
Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.
Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Experience working with FDA policies regulating clinical trials.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management.
Experience interpreting medical charts and abstracting data from medical records.
Knowledge of National Institute of Health (NIH), Good Clinical Practice (GCP), Injury and Illness Prevention Program (IIPP), Human Resource Protection Program (HRPP), IATA Shipping of Blood Specimens, and Bloodborne Pathogens.
Experience with clinical trials participant or study subject recruitment.
Experience providing in-service training to various research personnel on protocols, processes, and procedures.
Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a diverse population. Excellent phone etiquette skills.
Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.
- Experience working with FDA policies regulating clinical trials.
- Experience working with research bulk accounts.
- Experience with investigated drug authorization criteria.
- Certification as a clinical research associate or coordinator.
- Knowledge of hematology and bleeding disorders. Basic understanding of diagnosis,management and pathophysiology of bleeding disorders to determine patient eligibility for protocols and assure accurate randomization.
- Employment is subject to a criminal background check and pre-employment physical.
- Must be able to obtain annual TB/fit test clearance.
- Must be able to travel to different locations and work weekends and evenings as needed.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
If applicable, life-support certifications (BLS, NRP, ACLS, etc.) must include hands-on practice and in-person skills assessment; online-only certification is not acceptable.
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, the only Burn Center in the county, and and dozens of outpatient clinics. We invite you to join our team!
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