Extended Deadline: Wed 7/27/2022, thereafter Open Until filled
Salary Range: Commensurate with Experience
Under supervision of Training and Research Program Manager, the Clinical Research Assistant/Interviewer is responsible for coordinating and managing multi-site prospective pregnancy registry studies including providing all aspects of protocol management, including screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug reaction reports, and maintenance of accurate and complete clinical research files. Responsible for recruitment and follow-up of pregnant women who take certain medications and vaccines. The incumbent has knowledge of and is able to identify pregnancy exposure risks, has the ability to obtain and respond to very sensitive and personal health information over the telephone in a professional manner, as well as read and understand medical literature. The incumbent may promote the project at scientific and professional meetings, as well as distribute study materials to clinics in San Diego County.
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.
Demonstrated experience performing clinical research duties in a clinical research environment.
Experience using 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.
Proven 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.
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.
Thorough 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.
Demonstrated ability to interact effectively with diverse groups, including professional and non-professional staff and clients.
Certification as a Clinical Research Associate or Coordinator.
Experience working with research bulk accounts.
Experience with investigational drug authorization criteria.
Experience working in a call center.
Experience conducting phone interviews.
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.
Employment is subject to a criminal background check.
TB test is required.
Occasional evenings and weekends may be required.
Scheduled work hours may vary as this project follows subjects residing throughout North America and time zone differences require availability outside normal day-time working hours.
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 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!
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.
To foster the best possible working and learning environment, UC San Diego strives to cultivate a rich and diverse environment, inclusive and supportive of all students, faculty, staff and visitors. For more information, please visit UC San Diego Principles of Community - https://ucsd.edu/about/principles.html.
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