Clinical Research Regulatory Specialist

University of California - San Francisco
United States, California, San Francisco
Nov 15, 2024
Clinical Research Regulatory Specialist Radiology Full Time 80658BR Job Summary Uses skills as a seasoned, experienced research compliance professional with a full understanding of industry practices and organization policies / procedures to apply federal, state, and university regulations, policies, and guidelines, and promote best practices. Interacts frequently with investigators, persons in other organizational departments, and occasionally persons outside the University. Interactions require the use of tact and independent judgment, knowledge of standards and best practices, and counseling to resolve a wide range of research compliance issues. Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Errors or omissions may ultimately place research participant at undo risk and / or compromise the institution's assurance of regulatory compliance with the federal government. Under the direction of the Clinical Research Manager, and in compliance with University and Department policies and federal and state regulations, the Regulatory Specialist will work closely with investigators, their study teams, regulatory personnel, and sponsor partners to draft and manage study documents and regulatory submissions for new and existing studies. This includes managing all aspects of study activation and continued support through the duration of the study. Previous experience working on a clinical trial team, utilizing Microsoft Word document editing tools, and project management experience is a preferred. The final salary and offer components are subject to additional approvals based on UC policy. Your placement within the salary range is dependent on a number of factors including your work experience and internal equity within this position classification at UCSF. For positions that are represented by a labor union, placement within the salary range will be guided by the rules in the collective bargaining agreement. The salary range for this position is $84,000 - $126,000(Annual Rate). To learn more about the benefits of working at UCSF, including total compensation, please visit: https://ucnet.universityofcalifornia.edu/compensation-and-benefits/index.html Department Description The Department of Radiology & Biomedical Imaging is one of the largest departments in the School of Medicine at UCSF. Its mission is research (basic and clinical), teaching, patient care, and public service. Major activities of the department include general Radiology, Mammography, Interventional Radiology, CT, MRI, Ultrasound and Nuclear Medicine. The Department has 32 sections and research units, 150 full-time faculty, 285 staff, and 160 trainees across six sites: Parnassus, ZSFG, VA Medical Center, Mt. Zion, China Basin Landing, and Mission Bay (QB3). Many of our faculty conduct research activities and manage large research staffs, including students, fellows, post docs, and staff research associates. Some conduct bench research in wet lab settings; others have dry lab (computer based) research programs or specialize in clinical research. Required Qualifications Bachelor's degree in related area and / or equivalent experience / training. Minimum of 3 years of related experience Experience with clinical trials regulatory affairs Project management skills to oversee the administrative operations of the clinical trials program; knowledge of strategies for recruiting human subjects. Working knowledge of clinical trial design, clinical study operations, and regulatory approval processes. Working knowledge of clinical trial design, clinical study operations, and regulatory approval processes. Demonstrated self-discipline and sound, independent judgment completing complex assignments. Preferred Qualifications Clinical Trial Professional certification Thorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminology. Experience in University of California systems Experience in Radiology clinical research About UCSF The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care. It is the only campus in the 10-campus UC system dedicated exclusively to the health sciences. We bring together the world's leading experts in nearly every area of health. We are home to five Nobel laureates who have advanced the understanding of cancer, neurodegenerative diseases, aging and stem cells. Pride Values UCSF is a diverse community made of people with many skills and talents. We seek candidates whose work experience or community service has prepared them to contribute to our commitment to professionalism, respect, integrity, diversity and excellence - also known as our PRIDE values. In addition to our PRIDE values, UCSF is committed to equity - both in how we deliver care as well as our workforce. We are committed to building a broadly diverse community, nurturing a culture that is welcoming and supportive, and engaging diverse ideas for the provision of culturally competent education, discovery, and patient care. Additional information about UCSF is available at diversity.ucsf.edu Join us to find a rewarding career contributing to improving healthcare worldwide. Equal Employment Opportunity The University of California San Francisco is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Organization Campus Job Code and Payroll Title 006230 RSCH CMPLNC ANL 3 Job Category Administrative Support, Research and Scientific Bargaining Unit 99 - Policy-Covered (No Bargaining Unit) Employee Class Career Percentage 100% Location San Francisco, CA Campus China Basin (SF) Work Style Fully On-Site Shift Days, Variable Shift Length 8 Hours Additional Shift Details M-F, 8am-5pm or vary hours as needed