University of California - San Francisco Campus and Health
Clinical Research Regulatory Specialist
University of California - San Francisco Campus and Health, San Francisco, California, United States, 94199
Clinical Research Regulatory SpecialistDepartment:
RadiologyEmployment Type:
Full TimeJob Code:
80658BRJob 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 participants at undue 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.Salary Range:
$84,000 - $126,000 (Annual Rate)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).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.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.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.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:
CampusJob Category:
Administrative Support, Research and ScientificBargaining Unit:
99 - Policy-Covered (No Bargaining Unit)Employee Class:
CareerPercentage:
100%Location:
China Basin (SF), Flexible (combination of onsite and remote work)Shift:
Days, VariableShift Length:
8 HoursAdditional Shift Details:
M-F, 8am-5pm or vary hours as needed
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RadiologyEmployment Type:
Full TimeJob Code:
80658BRJob 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 participants at undue 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.Salary Range:
$84,000 - $126,000 (Annual Rate)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).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.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.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.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:
CampusJob Category:
Administrative Support, Research and ScientificBargaining Unit:
99 - Policy-Covered (No Bargaining Unit)Employee Class:
CareerPercentage:
100%Location:
China Basin (SF), Flexible (combination of onsite and remote work)Shift:
Days, VariableShift Length:
8 HoursAdditional Shift Details:
M-F, 8am-5pm or vary hours as needed
#J-18808-Ljbffr