Assistant Clinical Research Coordinator - 116176
As a federally-funded institution, UC San Diego Health maintains a marijuana and drug free campus. New employees are subject to drug screening.
#116176 Assistant Clinical Research CoordinatorExtended Deadline: Fri 7/8/2022
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 05/06/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 05/18/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will remain open until a successful candidate has been identified.
The Department of Medicine (DOM) is the largest department within the UCSD School of Medicine and is responsible for fulfilling the teaching, research, and clinical missions of the University of California, San Diego School of Medicine. The department employs approximately 500 salaried faculty, 168 academic appointees, 331 residents, fellow and postdocs and 479 staff personnel.
Under supervision from Principal Investigator and Clinical Research Supervisor II in the Pulmonary, Critical Care & Sleep Medicine Division, the Research Coordinator supports the ICU clinical research efforts for a variety of research projects and clinical trials focusing primarily on pulmonary disorders including COPD, cystic fibrosis, and IPF. Responsible for independently coordinating and managing research studies, including protocol management, screening for patient eligibility, consenting subjects, data collection and entry, patient follow-up, query resolution, and database management. The Research Coordinator will assist in the conduct of Clinical Trials by ensuring protocol compliance, filing adverse drug reaction reports, monitoring patient treatment and toxicities, laboratory and specimen submission, and maintenance of accurate and complete clinical research files. Will independently process Institutional Review Board (IRB) submissions and amendments.
Reporting directly to Clinical Research Supervisor II, 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. Provide direct assistance to the Project Manager in reviewing and verifying university research account statements, professional fee statements, and invoicing.
Theoretical knowledge in biology, immunology, 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.
Demonstrated knowledge of 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 interpretation and understanding of research protocols in order to screen patients for eligibility, initiate treatment plan, collect specimens, and orient participating physicians.
Thorough knowledge of IRB and Human Subjects Research requirements, to include the informed consent and Patient's Bill of Rights.
Strong interpersonal skills, including excellent written and verbal communication skills; ability to with a diverse group of people to include physicians, patients and their families.
Experience working in a Pulmonary & Critical Care Office or clinical research environment including knowledge of pulmonary medical terminology.
Experience working with patients with Pulmonary Hypertension or similar respiratory diseases either in a clinical or research setting. Knowledge of diagnostic studies used and medications used to treat pulmonary hypertension.
Experience with investigational drug authorization criteria.
- Certification as a clinical research associate or coordinator.
- Experience working with research bulk accounts.
- Employment is subject to a criminal background check and pre-employment physical.
- Occasional evenings and weekends may be required.
- Must be willing to travel to occasional meetings and work weekends and evenings as needed.
- Must be willing to work with human blood and biohazardous materials.
- Must have access to reliable transportation.
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!
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.
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.