112665 - Sr. Clinical Research Coordinator
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#112665 Sr. Clinical Research CoordinatorExtended Review Date: Mon 11/29/2021
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
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 11/04/2021 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/15/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Clinical and Translational Research Institute (CTRI) was established to provide education, training and infrastructure for clinical research in the San Diego area that encompasses four hospital systems, two universities and four biomedical research organizations. It has significant support through a Clinical and Translational Science Award funded by the National Center for Advancing Translational Science. The clinical coordinator core is housed in the Center for Clinical Research, a division of the CTRI.
The Sr. Clinical Research Coordinator will oversee Clinical Trials Administration and Regulatory compliance, coordination and documentation of specified pharmaceutical clinical trials and protocols. Responsible for development of protocols and execution of procedures. Responsible for ensuring that all procedures comply with regulatory procedures and standard operating procedures. Design case report forms for PI initiated and Sponsor provided protocols. Assume responsibility for multi-site clinical trials for the Clinical and Translational Research Institute and its partners, including Rady Hospital. Responsibilities include the development and maintenance of all study related documents and procedures for the FDA, CRO and Pharmaceutical Company; oversee execution of protocols to be conducted at the site; and coordinate, assign, and evaluate the activities of in-house coordinating staff to ensure FDA Compliance and Good Clinical Practice.
This position will require developing, updating and refining of Standard Operating Procedures. Additionally, responsible for study recruitment, including the innovation of screening process to improve patient and clinical trial databases. Responsible for performing protocol defined procedures as required. Independently collect and analyze scientific data for publication, identify and develop new clinical trial protocols, train and monitor research staff, medical students, fellows, hospital nurses assigned to these protocols. Incumbent is required to use Velos, a mandatory clinical trials management system that is used to track all patients enrolled in a clinical trial, track all scheduled visits and individual events performed at each visit and is used for studies that have a conventional care coverage analysis.
Strong theoretical knowledge and/or Bachelor's Degree in a life science and/or an equivalent combination of education and work experience.
Must have current CPR certificate or ability to attain within two (2) months of hire date.
Experience in research protocol activation, marketing, outreach, recruitment and maintaining a research study cohort.
Ability to work in a team environment. Excellent communication skills.
Ability to read, understand, and learn study procedures from protocols. Ability to problem solve. Strong knowledge of the clinical research setting, protocols, principles, and standards. Excellent planning and organization skills.
Experience in maintaining quality control in clinical trial protocols, including adherence to the protocol requirements and data management.
Analytical and evaluative ability to evaluate clinical trial data and PI/Sponsor needs.
Experience in analyzing research data, extracting pertinent data, analyzing and presenting data effectively.
Experience interpreting clinical findings to assure compliance with the protocol and prompt reporting of adverse events and protocol deviations.
Demonstrated experience with composing clinical trials reports including HRPP applications, protocol amendments, adverse event reports, close out documents, CRFs.
Experience using clinical trials management software. VELOS experience highly desirable.
- Three (3) years of experience conducting clinical trials, including sponsored trials and investigator initiated protocols.
- Certification by ACRP.
- Certified Phlebotomy Technician (CPT) by the State California and experience performing phlebotomy/venipuncture.
- Fluency in English and at least one other language. Spanish is highly preferred.
- Experience performing vital signs.
- Experience using clinical laboratory equipment including pipettes, centrifuges, ECG machines. Knowledge of good clinical practice guidelines.
- Employment is subject to a criminal background check and pre-employment physical.
- Must be willing to travel to various sites and national meetings.
- Must be able to work overtime, nights and weekends if required for the research protocol.
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 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, and several outpatient clinics. UC San Diego Medical Center in Hillcrest is a designated Level I Trauma Center and has the only Burn Center in the county. We invite you to join our dynamic 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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