University of California - San Francisco Campus and Health
Regulatory Manager
University of California - San Francisco Campus and Health, San Francisco, California, United States, 94199
Regulatory Manager
MED-CORE-CARD
Full Time
79462BR
Job Summary
The Cardiology Research Regulatory Manager is 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.The final salary and offer components are subject to additional approvals based on UC policy.To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.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 Division of Cardiology is one of the largest clinical, research and training divisions of the Department of Medicine (DOM) at UCSF. The Division has developed a well-established Cardiology Clinical Research Unit (CCRU) which supports 60-70 active clinical trials. The CCRU research portfolio covers phase I- IV and post approval trial types and covers a diversity of trials ranging from pharmaceutical, device, preventative, and social behavioral research. Within the Division are sub-specialty sections for:
Adult Congenital Heart Disease; Advanced Heart Failure, Transplant, and Pulmonary Hypertension; Cardiac Electrophysiology; Critical Care Cardiology; Cardio-Oncology and Immunology; Echocardiography and Cardiac Imaging; General Cardiology, Interventional Cardiology; and Prevention.
The Division runs several clinical practices in multiple sites, conducts basic and clinical research, and educates medical students, residents, clinical fellows through ACGME as well as non-ACGME training programs.
In addition, the Division has significant and complex financial and administrative relationships with the Department of Medicine (DOM) and the UCSF Medical Center, as well as large patient care programs in the sections noted above, large clinical, Federal, and privately supported research programs and six faculty laboratories.
The Division has 80 full-time faculty, several non-faculty academics, 36 clinical fellows, several post-doctoral research fellows, and approximately 60 research support and administrative staff.
The Division currently expends over $22 million per year in pursuit of its clinical, research, training, and service missions.
While the Division is primarily split between the Parnassus and Mission Bay campuses, clinical fellows have rotations at the Zuckerberg San Francisco General Hospital and the San Francisco Veterans Affairs Medical Center.
Required Qualifications
Bachelor's degree in related area and three or more years of relevant experience and / or equivalent experience / trainingDemonstrated self-discipline and sound, independent judgment completing complex assignmentsThorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documentsThorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminologyDemonstrated proficiency in public speaking, and writingConflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interestProficient in ability to use discretion and maintain all confidentialityProficient in ability to multi-task with demanding timeframes
Preferred Qualifications
Knowledge of OnCore system and other clinical trial management systemsExperience working in clinical research at a university, academic medical center, or public health organizationFluency in software systems such as Microsoft Excel, Word, Outlook, BOX, MyResearch, RedCap, and Qualtrics
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
Research and Scientific
Bargaining Unit
99 - Policy-Covered (No Bargaining Unit)
Employee Class
Career
Percentage
100%
Location
Parnassus Heights (SF)
Shift
Days
Shift Length
8 Hours
Additional Shift Details
Monday-Friday 8:00-5:00pm
#J-18808-Ljbffr
MED-CORE-CARD
Full Time
79462BR
Job Summary
The Cardiology Research Regulatory Manager is 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.The final salary and offer components are subject to additional approvals based on UC policy.To see the salary range for this position (we recommend that you make a note of the job code and use that to look up): TCS Non-Academic Titles Search (https://tcs.ucop.edu/non-academic-titles)Please note: An offer will take into consideration the experience of the final candidate AND the current salary level of individuals working at UCSF in a similar role.For roles covered by a bargaining unit agreement, there will be specific rules about where a new hire would be placed on the range.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 Division of Cardiology is one of the largest clinical, research and training divisions of the Department of Medicine (DOM) at UCSF. The Division has developed a well-established Cardiology Clinical Research Unit (CCRU) which supports 60-70 active clinical trials. The CCRU research portfolio covers phase I- IV and post approval trial types and covers a diversity of trials ranging from pharmaceutical, device, preventative, and social behavioral research. Within the Division are sub-specialty sections for:
Adult Congenital Heart Disease; Advanced Heart Failure, Transplant, and Pulmonary Hypertension; Cardiac Electrophysiology; Critical Care Cardiology; Cardio-Oncology and Immunology; Echocardiography and Cardiac Imaging; General Cardiology, Interventional Cardiology; and Prevention.
The Division runs several clinical practices in multiple sites, conducts basic and clinical research, and educates medical students, residents, clinical fellows through ACGME as well as non-ACGME training programs.
In addition, the Division has significant and complex financial and administrative relationships with the Department of Medicine (DOM) and the UCSF Medical Center, as well as large patient care programs in the sections noted above, large clinical, Federal, and privately supported research programs and six faculty laboratories.
The Division has 80 full-time faculty, several non-faculty academics, 36 clinical fellows, several post-doctoral research fellows, and approximately 60 research support and administrative staff.
The Division currently expends over $22 million per year in pursuit of its clinical, research, training, and service missions.
While the Division is primarily split between the Parnassus and Mission Bay campuses, clinical fellows have rotations at the Zuckerberg San Francisco General Hospital and the San Francisco Veterans Affairs Medical Center.
Required Qualifications
Bachelor's degree in related area and three or more years of relevant experience and / or equivalent experience / trainingDemonstrated self-discipline and sound, independent judgment completing complex assignmentsThorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documentsThorough knowledge and experience with quantitative and qualitative research design; scientific research concepts and terminologyDemonstrated proficiency in public speaking, and writingConflict of Interest: Understanding of stock options, consulting agreements and other corporate documents related to research and analysis of potential conflicts of interestProficient in ability to use discretion and maintain all confidentialityProficient in ability to multi-task with demanding timeframes
Preferred Qualifications
Knowledge of OnCore system and other clinical trial management systemsExperience working in clinical research at a university, academic medical center, or public health organizationFluency in software systems such as Microsoft Excel, Word, Outlook, BOX, MyResearch, RedCap, and Qualtrics
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
Research and Scientific
Bargaining Unit
99 - Policy-Covered (No Bargaining Unit)
Employee Class
Career
Percentage
100%
Location
Parnassus Heights (SF)
Shift
Days
Shift Length
8 Hours
Additional Shift Details
Monday-Friday 8:00-5:00pm
#J-18808-Ljbffr