Assistant Clinical Research Coordinator - 111014
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#111014 Assistant Clinical Research CoordinatorExtended Deadline: Tue 1/25/2022
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 08/10/2021 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 08/20/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will remain open until a successful candidate has been identified.
The Division of Gastroenterology in the Department of Medicine conducts research studies which study Nonalcoholic Steatohepatitis (NASH) and Nonalcoholic Fatty Liver Disease (NAFLD) in adult patients. The Non-Alcoholic Steatohepatitis Clinical Research Network (NASHCRN) is a multi-center study funded by NIH and is sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to focus on the etiology, contributing factors, natural history, complications, and therapy of NASH and NAFLD. UCSD is one of eight sites nationwide associated with this study.
In addition, the NAFLD Research Center participates in pharmaceutical clinical trials and Principal Investigator (PI) initiated studies that focus on the discovery and validation of innovative biomarkers for NAFLD, with a special focus on identifying those patients at greatest risk for nonalcoholic steatohepatitis (NASH), advanced liver fibrosis, and hepatocellular carcinoma (HCC).
Reporting directly to the Clinical Research Supervisor. Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including creating study specific source documents, screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Assist the regulatory department with Human subjects submissions, renewals, and safety reports. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards (where applicable). Provide direct assistance to the Supervisor in reviewing and verifying university research account statements, professional fee statements, and invoicing.
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, experience in 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 coordinating study startup activities.
Experience providing in-service training to various research personnel on protocols, processes, and procedures.
Knowledge of x-rays, scans, and other diagnostic 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.
- Certification as a Clinical Research Associate or Coordinator.
- Experience working with research bulk accounts.
- Experience with investigational drug authorization criteria.
- Employment is subject to a criminal background check and pre-employment physical.
- Occasional evenings and weekends may be required.
Job offer is contingent on successful engagement in the UC COVID-19 Vaccination program (fully vaccinated with documented proof or approved exception/deferral).
UC San Diego Health Sciences is comprised of our School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, The Herbert Wertheim School of Public Health and Human Longevity Science, and our Student Health and Well-Being Department. We have long been at the forefront of translational - or "bench-to-bedside" - research, transforming patient care through discovery and innovation leading to new drugs and technologies. Translational research is carried out every day in the hundreds of clinical trials of promising new therapies offered through UC San Diego Health, and in the drive of our researchers and clinician-scientists who are committed to having a significant impact on patient care. We invite you to join our 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
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