112856 - Sr. Clinical Research and Regulatory Coordinator
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#112856 Sr. Clinical Research and Regulatory CoordinatorExtended Deadline: 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 11/08/21 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/17/21. 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. Their Clinical Trials Office provides diagnosis and management of benign and malignant tumors for inpatient and outpatient cases, offering access to novel therapeutics.
Reporting directly to the Administrative Director, the Senior Clinical Research and Regulatory Coordinator coordinates the clinical research efforts of the Moores UCSD Cancer Center Clinical Trials Office. Responsible for coordinating and managing clinical trial activity conducted at the UCSD VA location; this includes: providing all aspects of protocol management, such as 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. Coordinate development of cooperative group affiliation including credentialing, data entry support, and coordination of training.
Assist the regulatory department with human subjects submissions, renewals, and safety reports. Oversee research protocol writing, start-up procedures, implementation, recruitment, and close out procedures. Directly communicate with assigned physicians and disease groups, including attending weekly meetings and tumor boards. Provide direct assistance to the Research Director in reviewing and verifying research account statements, professional fee statements, and invoicing. Coordinate research efforts with the Moores Cancer Center team through close communication and collaboration with the Associate Administrative Director and Administrative Director.
Act as a liaison with other departments and community clinics / agencies for the purpose of implementation of studies. Assure compliance with state and federal regulatory guidelines. Oversee the quality of the medical and clinical research data. Provide direction and guidance to investigators. Provide education and information to the general public concerning the ongoing clinical trials. Assist PIs with proposals, progress reports and manuscripts. Work closely with federal and state regulatory officials.
Bachelor's Degree or advanced theoretical knowledge in a social science or basic science such as Biology, Microbiology' or a related field and/or equivalent work experience.
Experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures. Experience in clinical trials research including budget negotiations and invoicing per clinical trial agreement.
Proven experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect, process, and ship specimens, and orient participating physicians.
Experience in medical assessment and patient interviewing to determine toxicities related to protocol management. Experience with laboratory procedures and values and experience in interpreting them to determine patient eligibility and potential toxicities.
Strong knowledge of investigational protocols (data management, query resolution, protocol design, protocol writing, evaluation, and protocol implementation). Working knowledge of medical and scientific terminology.
Demonstrated experience in clinical trials research. Experience completing clinical trials case report forms via hard copy and online.
Experience working with FDA policies regulating clinical trials.
Experience preparing various forms, documents, and reports, such as Investigational Drug Fact Sheet, 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.
Excellent interpersonal, written and verbal communication skills (using grammatically correct written English and accurate typing) to interact with a variety of personalities at the organization, exercising tact, mature judgment, diplomacy, and flexibility to promote positive working relationships and job effectiveness. Developing internal and external network of contacts. Excellent phone etiquette skills.
Computer proficiency, including working knowledge of word processing, spreadsheet software (Microsoft Office) and internet browser applications. Experience in conducting searches on the internet.
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.
- Knowledge of cost accounting as applied to both University and Medical Center functions. Knowledge of medical billing and collections guidelines and procedures.
- Possess a Clinical Research Coordinator Certificate, or Master's Degree.
- Knowledge of hematology/oncology or radiation 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.
- Must have access to transportation, work occasional overtime, and travel to various clinic sites approximately 5% of the time to oversee research studies.
- Must successfully complete annual TB/fit test clearance.
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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