Clinical Trials Regulatory Research Associate - 124190
#124190 Clinical Trials Regulatory Research AssociateExtended Review Date: Mon 12/4/2023
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.
This position will remain open until a successful candidate has been identified.
UCSD Layoff from Career Appointment: Apply by 07/19/2023 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 07/28/2023. Eligible Special Selection clients should contact their Disability Counselor for assistance.
This position will work a hybrid schedule which includes a combination of working both onsite at Moores Cancer Center and remote.
he Moores Cancer Center is one of just 54 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. As a top-ranking, future-oriented organization, we offer challenging career opportunities in a fast-paced and innovative environment. Moores Cancer Center follows a progressive philosophy of career-path development for its employees including opportunities for cross-training, professional development, and progressive responsibility.
MCC's mission is to transform cancer care in our catchment area and beyond by driving exceptional scientific discoveries, and innovations in prevention, detection, care, and training. MCC will make a global impact on improving health by reducing cancer burden through accelerated discovery and translation, compassionate and interdisciplinary care, education and community engagement, with the foundation of our core values - Excellence, Innovation and Risk-Taking, Collaboration, Diversity and Service.
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.
Under full supervision, the Clinical Trials Regulatory Research Associate is responsible for the development and maintenance of regulatory documents pertaining to the clinical trials conducted by investigators at the Cancer Center. Key to this role is the preparation of clinical trial protocols and related regulatory documents for submission to the UCSD Human Research Protections Program (UCSD's Institutional Review Board or IRB) in order to obtain its approval for the clinical trials to proceed. The Regulatory Research Associate 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. This position requires regular interaction with a variety of internal and external contacts including Cancer Center investigators and staff, UCSD IRB staff, study sponsors and/or their representatives. Other duties assigned as needed.
Knowledge of medical and pharmaceutical terminology and concepts, as well as theoretical knowledge and/or Bachelor's degree and/or equivalent education and/or experience in a field related to biological sciences as needed to work in Regulatory Affairs.
Experience working with FDA regulations, NCI policies and procedures, and Good Clinical Practice guidelines for the conduct of clinical research.
Experience creating Informed Consent Documents that comply with HRPP/UCSD IRB policies and procedures, FDA regulations, and sponsor 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.
Experience using standard word processing and data management software programs, including Word and Excel, in order to develop and prepare reports.
Experience developing and maintaining record management systems. Strong administrative and organization skills, experience prioritizing assignments when faced with a heavy workload and competing deadlines.
Excellent interpersonal, as well as written and oral 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.
Experience with editing, including summarizing information into concise and condense documents.
Skill in working independently and following through on assignments with minimal supervision. Good judgement to know when to ask for assistance from supervisor in cases where regulations and policies and procedures are not clear.
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.
Demonstrated ability to exercise judgment, tact, and firmness in interaction with faculty, students, staff and IRB members, subjects and others.
Demonstrated knowledge or demonstrated 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 oncology and hematology.
- Working knowledge of UCSD Human Research Protections Program (HRPP/IRB) policies and Procedures.
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 (may include attending PRMC meetings twice per month, as needed).
Pay Transparency Act
Annual Full Pay Range: $64,812 - $104,275 (will be prorated if the appointment percentage is less than 100%)
Hourly Equivalent: $31.04 - $49.94
Factors in determining the appropriate compensation for a role include experience, skills, knowledge, abilities, education, licensure and certifications, and other business and organizational needs. The Hiring Pay Scale referenced in the job posting is the budgeted salary or hourly range that the University reasonably expects to pay for this position. The Annual Full Pay Range may be broader than what the University anticipates to pay for this position, based on internal equity, budget, and collective bargaining agreements (when applicable).
If employed by the University of California, you will be required to comply with our Policy on Vaccination Programs, which may be amended or revised from time to time. Federal, state, or local public health directives may impose additional requirements.
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!
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