Sr. Clinical Research Coordinator - 112791
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#112791 Sr. Clinical Research CoordinatorExtended Deadline: Thu 1/27/2022
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 11/15/2021 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 11/29/2021. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The UCSD Moores Cancer Center (MCC) is one of only 49 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 Associate Administrative Director, the Sr. Clinical Research Coordinator coordinates the clinical research efforts of the Moores UCSD Cancer Center Clinical Trials Office at the Encinitas location. The incumbent is responsible for coordinating and monitoring clinical trials including providing all aspects of protocol oversight, including but not limited to screening for patient eligibility, data collection and analysis, ensuring protocol compliance, adverse drug/therapy 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 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 as assigned. 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.
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.
Strong theoretical knowledge and/or Bachelor's Degree 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.
Demonstrated experience with research protocol in order to screen patients for eligibility, initiate treatment plan, collect 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.
Experience interpreting medical charts and abstracting data from medical records.
Thorough knowledge of experimental protocols, data gathering, protocol design and evaluation.
Knowledge of investigational protocols especially with radiation oncology protocols (data management, query resolution, protocol design, protocol writing, evaluation, and protocol implementation). Working knowledge of medical and scientific terminology.
Strong experience in clinical trials research.
Proven ability to find creative and innovative solutions to adjusting needs of the center. Ability to be resourceful and to understand the overall nature of work/responsibilities to establish useful resources and University contacts.
Experience working with FDA policies regulating clinical trials.
Proven ability to problem solve and resolve conflict.
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.
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 20% 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 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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