Regulatory PRMC Coordinator - 119358
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#119358 Regulatory PRMC CoordinatorExtended Review Date: Tue 11/1/2022
UC San Diego values equity, diversity, and inclusion. If you are interested in being part of our team, possess the needed licensure and certifications, and feel that you have most of the qualifications and/or transferable skills for a job opening, we strongly encourage you to apply.
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 10/13/2022 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 10/24/2022. Eligible Special Selection clients should contact their Disability Counselor for assistance.
The Moores Cancer Center is one of just 52 NCI-designated Comprehensive Cancer Centers in the United States and the only one in San Diego County. As a consortium cancer center, it is a collaborative partnership between the UCSD: encompassing 14 departments (12 clinical, 2 basic sciences), 3 professional schools (School of Medicine, Skaggs School of Pharmacy and Pharmaceutical Sciences, School of Public Health), UCSD Health oncology hospitals and clinics; the basic and public health research and outreach of San Diego State University, and the basic and translational research of the La Jolla Institute of Immunology. These various programs and units are all dedicated to fulfilling the Moores Cancer Center's mission of reducing cancer's burden. As such, it ranks among the top centers in the nation conducting the continuum of cancer research, providing advanced patient care, and serving the community through outreach and education programs.
The Clinical Trials Office (CTO) at UCSD's Moores Cancer Center administers many clinical trials on behalf of its member investigators, including trials sponsored by National Cancer Institute cooperative groups, pharmaceutical companies, and physician investigators.
This Protocol Review and Monitoring Committee (PRMC) Coordinator position is key in coordinating all administrative aspects of the protocols that will be reviewed for scientific merit by the Protocol Review and Monitoring Committee. The PRMC Coordinator will work closely with oncologists, translational researchers, bioinformaticians, pathologists, and geneticists in clinical projects whose objective is to further personalize medicine and cancer clinical trials at UC San Diego Moores Cancer Center. The incumbent duties will include coordination of all aspects of the protocols that will be reviewed for scientific merit by the Protocol Review Monitoring Committee; assisting in coordinating and overseeing start-up procedures, project implementation, screening, enrollment, and maintenance of patient and subject data; to create informational and training materials and act as a liaison with other UCSD departments and community clinics/agencies; oversee the quality of the medical and clinical research data collected per protocol procedures; assist PIs with proposals, progress reports, and manuscripts. This position is responsible for the tracking and initial administrative review of the PRMC application submissions.
The PRMC Coordinator will be responsible for providing technical and administrative support to the PRMC Analyst, for preparing meetings, as well as coordinating follow-up during and after PRMC meetings. This involves writing confirmation letters and requirement letters to the Clinical Investigators, scheduling their presentations, and writing approval or approve-pending letters or deferral, as pertinent. There will be the need to track individual project enrollment and determine whether the annual target is met and, thus, determine if the study should remain open.
Key to this role is the administrative support for preparing clinical trial protocols and related regulatory documents for submission to the Protocol Review and Monitoring Committee (PRMC) to obtain its approval for the clinical trials to proceed. The PRMC Coordinator will act as a resource to the PRMC Analyst and indirectly to investigators and PRMC Chair for the interpretation and execution of complex clinical research regulations, policies & procedures concerning the conduct of clinical trials, including those of the FDA, HHS, NIH, NCI, and UCSD IRB. Other duties assigned as needed.
Working knowledge of medical and pharmaceutical terminology and concepts, and/or of biological science, sufficient to understand the contents of medical research protocols and research processes. Understanding of scientific terminology in order to apply this to regulatory submissions for protocol review and scientific committee's requirements.
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.
Strong knowledge of investigational protocols (various trial products, data gathering, phases and protocol designs). Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Experience developing and maintaining record management systems. Experience and ability to accurately collect, record, transcribe and synthesize clinical data.
Experience working in a clinical research environment such as CRO, academic research institution, and/or a research hospital. Experience reading and interpreting clinical trials research protocols. Administrative experience in summarizing protocol reviews, ability to format and edit minutes for the Protocol Review and Monitoring Committee.
Knowledge of technical programs supporting recording, videotaping, and remote-meeting access, similar to Zoom and MS Teams.
Strong administrative experience using standard word processing and data management software programs, including Word and Excel, to develop and prepare reports. Computer proficiency, including working knowledge of various software programs (such as Adobe Acrobat, web browsers, VELOS, REDCap, etc.) and internet browser applications. Experience in conducting searches on the internet. Ability and willingness to learn new software as needed.
Effective 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. Skill at negotiating with various personalities and developing internal and external network of contacts. Excellent phone etiquette skills.
Excellent ability to organize/prioritize workload effectively to meet deadlines in an environment with multiple interruptions and changing priorities. Meticulous attention to detail. Demonstrated administrative experience, skill to coordinate complex activities and to use independent judgment to organize and prioritize office functions.
Experience with editing, including summarizing information into concise and condensed documents.
Demonstrated ability to work with large central databases.
Experience producing clinical regulatory documents, including proposals, consents, adverse event reports and close out documents.
Proven experience in research protocol start-up procedures, including: study feasibility, study activation and IRB processes, and qualification procedures.
Knowledge of evolving US regulations, guidelines, and specifications applicable to clinical research. Experience interpreting regulations, guidelines, and precedents related to drugs and biologics development.
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.
- Employment is subject to a criminal background check and pre-employment physical.
- Must be able to maintain strict confidentiality.
- Must be available to work occasional evenings and weekends (will coordinate and attend PRMC meetings twice per month, as needed).
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 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!
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.
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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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