La Jolla, California
Grand Rapids, Michigan
Boston, Massachusetts
Boston, Massachusetts
Alexandria, Virginia
Alexandria, VA
Posted: 13-Sep-23
Location: La Jolla, California
Salary: Open
Internal Number: 125228
UCSD Layoff from Career Appointment: Apply by 09/14/2023 for consideration with preference for rehire. All layoff applicants should contact their Employment Advisor.
Special Selection Applicants: Apply by 09/25/2023. 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.
DESCRIPTION
The Moores Cancer Center is one of just 53 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 the direct supervision of the Project Manager, 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 Clinical Trials 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. This position may assist with study data collection and other duties assigned as needed.
MINIMUM QUALIFICATIONS
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 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. Ability to maintain confiden
Connections working at University of California San DiegoUC San Diego is an academic powerhouse and economic engine, recognized as one of the top 8 public universities by U.S. News and World Report. Innovation is central to who we are and what we do. Here, students learn that knowledge isn't just acquired in the classroom - life is their laboratory. UC San Diego's rich academic portfolio includes six undergraduate colleges, five academic divisions and five graduate and professional schools. The university's award-winning scholars are experts at the forefront of their fields with an impressive track record for achieving scientific, medical and technological breakthroughs.More Jobs from This Employerhttps://jobs.magazine.org/jobs/19135046/clinical-trials-regulatory-research-associate