Clinical Research and Regulatory Coordinator - 114885
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#114885 Clinical Research and Regulatory CoordinatorExtended Deadline: Tue 5/24/2022
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
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 03/14/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 03/23/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The UCSD Moores Cancer Center (MCC) is one of only 51 National Cancer Institute-designated Comprehensive Cancer Centers in the United States. This designation is reserved for cancer centers with the highest achievements in cancer research, clinical care, education, and community contributions. Moores Cancer Center strives to stay at the forefront of emerging cancer research in a patient centric environment. Principal Investigators (PIs) in the MCC conduct clinical trials to find better ways to prevent cancer, treat cancer, and care for cancer patients. Under the Clinical Trials Office (CTO), the investigators with IRB approved protocols have studies that may involve data and biological sample collection. Some examples of these biological samples are blood, urine, stool, viable tumor samples, and tissue samples; all with associated clinical information. Samples are collected from consented subjects and de-identified clinical information on the subjects is collected over time. Processing these samples are critical to the success of the clinical trials research studies. Additionally, there is a large amount of database entry, tracking, maintenance, and quality assurance related to these projects.
Reporting directly to the Data and Specimen Manager, the Clinical Research and Regulatory Coordinator will coordinate clinical research efforts for the Moores UCSD Cancer Center Clinical Trials Office (CTO). The incumbent is responsible for coordinating and managing clinical trials including providing all aspects of protocol management, screening for patient eligibility, data collection and analysis, ensuring protocol compliance, monitoring patient on study, and maintenance of accurate and complete clinical research files. They are responsible for the development and organization of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center. They will act as a resource to investigators and staff for interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, UCSD IRB, and the CTO. They are a liaison between the investigators, project manager, and sponsors and requires regular interaction with a variety of internal and external contacts including Cancer Center staff, UCSD staff, study sponsors and/or their representatives. The Clinical Research and Regulatory Coordinator will maintain the laboratory and supplies, coordinate and process specimen and shipment for clinical research studies. Other duties assigned as needed.
Theoretical knowledge in biology, microbiology, social sciences, or related field, as typically attained by a Bachelor's degree and/or equivalent combination of education and work experience.
Experience of handling patients' biological samples, processing of samples, storing the samples and shipping of samples. Experience with handling lab equipment sterile technique biosafety hoods and hazardous materials.
Ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others. Ability to interact with a large variety of physicians, project managers, study coordinators and cancer patients in a professional and pleasant manner.
Experience providing in-service training to various research personnel on protocols, processes, and procedures.
Experience performing clinical research duties in a clinical research environment. Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Experience interpreting medical charts and abstracting data from medical records in relation to study subject screening.
Knowledge to comply with the State of California laboratory guidelines/requirements regarding biosafety/universal precautions.
Demonstrated ability and willingness to handle blood, urine, stool, tissue, and other biological specimen for processing and shipping.
Excellent interpersonal, as well as written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at all levels of the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Excellent phone etiquette skills.
Proficient ability and knowledge of using computer software applications including email, word processing, database and spreadsheet applications such as Excel, MS Word; as well as completing clinical trials case report forms.
Proven ability to determine sources of information and data, and to analyze the data and information obtained, in order to create documents and to propose solutions to issues. Detail oriented, logical, and methodological approach to problem solving.
Experience in medical assessment, patient interviewing, and interpreting laboratory procedures and values to determine toxicities and patient eligibility related to protocol management.
Experience preparing various forms, documents, and reports, such as New Study Applications, Renewal Applications, IND Applications, etc. Experience preparing, reviewing, and understanding clinical research protocols and protocol amendments.
Experience creating Informed Consent Documents that comply with HRPP/UCSD IRB policies and procedures, FDA regulations, and sponsor requirements.
Experience with editing, including summarizing information into concise and condense documents.
Demonstrated knowledge or related experiences to comprehend, interpret, and apply regulations and legislation regarding the protection of human subjects. These include regulations under federal policies, FDA, and other compliance agencies or directive.
- Knowledge of hematology/oncology. Ability to differentiate various cancers by stage, histology, and site to determine patient eligibility for protocols and assure accurate randomization.
- Employment is subject to a criminal background check and pre-employment physical.
- Annual TB screen.
- Must be able to maintain confidentiality.
- Must be willing and able to work weekends and evenings when necessary.
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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