Assistant Clinical Research Coordinator - 119540
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#119540 Assistant Clinical Research CoordinatorInitial Review Date: Tue 11/22/2022
UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.
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UCSD Layoff from Career Appointment: Apply by 10/20/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/01/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The UC San Diego Alpha Stem Cell Clinic is the cell therapy arm of the Sanford Stem Cell Clinical Center and specializes in early phase, first-in-human trials. The Sanford Stem Cell Clinical Center is devoted to accelerating the translation of all types of stem cell research to safe and effective therapies. It attracts patients, funding agencies and study sponsors to participate in, support, and accelerate novel stem cell clinical trials and ancillary studies for a range of difficult diseases. The Sanford Stem Cell Clinical Center is a wide-ranging collaboration with unique contributions from UC San Diego Health, the Sanford Consortium for Regenerative Medicine, industrial sponsors, and philanthropy launched by the $100M Sanford Gift, and by CIRM through the Alpha Clinic and other grants.
The Assistant Clinical Research Coordinator coordinates the clinical research efforts of the UCSD CIRM Alpha Stem Cell Clinic.
Responsible for coordinating and managing clinical trials including providing all aspects of protocol management, including 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. Provide direct assistance to the Project Manager 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 with clinical trials participant or study subject recruitment.
Experience using statistical software applications. Knowledge of database, word processing and spreadsheet applications such as Velos, Access, Excel and MS Word.
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 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.
Excellent planning and organizational skills and ability to work in a changing, multiple-demand setting in order to prioritize a large volume of work and meet deadlines efficiently and accurately.
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.
- Pre-employment physical and TB test required.
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!
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