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Regulatory Specialist
Ortho-Clin Outcome Ctr-Core Job Summary The Department of Orthopaedic Surgery is looking for a candidate experienced in high volume clinical trials, protocol development, and regulatory submissions to work with investigators to prepare, submit, provide guidance, and manage the regulatory submissions. for a large portfolio of Investigator Initiated Trials as well as Sponsored Projects.
Under the direction of the Research Administration and Operations Director, and in compliance with University and Department policies and federal and state regulations, this individual 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 in the department.
The successful candidate will have experience working with clinical trials and their Principal Investigators (PIs), reviewing, and developing clinical trial protocols and consent forms, and have experience submitting to regulatory agencies, including IRB and FDA submissions. Previous experience working on a clinical trial team is a preferred.
General responsibilities of the Investigator Initiated Trials Protocol Development and Regulatory Specialist include:
- 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, 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.
- Attention to detail as 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.
- Clinicaltrial.gov registration and activation.
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 Department of Orthopaedic Surgery will provide the highest quality of patient care, conduct innovative clinical, basic science, and translational research, and train the next generation of global leaders in Orthopaedic Surgery. The UCSF Department of Orthopaedic Surgery runs a comprehensive research program including basic science, biomechanics, clinical, policy and global health research. The collective goal of our orthopaedic investigators is to improve the care of patients with musculoskeletal conditions in the broadest sense. Required Qualifications
- Bachelor's degree in biological sciences, public health, psychology, sociology, or another research-focused discipline and 3+ years of relevant experience; and/or equivalent education and experience in clinical research
- Demonstrated self-discipline and sound, independent judgment completing complex assignments
- Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents
- 3 years of experience in clinical research, preferably in compliance/regulatory role
- Minimum 2 years of experience preparing submissions for the Institutional Review Board, the FDA, other regulatory organizations and/or scientific review committees
- Understanding of clinical research methods and operations, the Institutional Review Board, the Food and Drug Administration IND and IDE submission processes and submitted to other research review committees and regulatory bodies
- Thorough knowledge and ability to apply all relevant Federal, state, and university regulations, policies, and federal guidance documents
- Proficiency using computers in a Windows environment, including advanced skills in Microsoft Word and Excel
- Experience applying the following regulations and guidelines: Good Clinical Practice Guidelines; Health Information and Accountability Act (HIPAA); The Protection of Human Research Subjects; CHR regulations for recruitment and consent of research subjects
Preferred Qualifications
- Minimum 2 years working on investigator-initiated studies, including, but not limited to, writing consent forms, coordinating development of protocols, and managing timelines for various submissions
- Fluency in the usage of Committee of Human Research (CHR) online iMEDris system for submission, renewal, and modification of protocols through this system
- Knowledge of UCSF and departmental policies, guidelines for research, confidentiality and HIPPA regulations, following the UCSF mission statement and purpose for research, and a clear understanding of policies and procedures on patient safety and confidentiality (electronic and hard copy medical records, patient charts, communication, etc.); knowledge of medical terminology
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. Job Code and Payroll Title 006230 RSCH CMPLNC ANL 3 Job Category Research and Scientific Bargaining Unit 99 - Policy-Covered (No Bargaining Unit) Location San Francisco, CA Campus Parnassus Heights (SF) Additional Shift Details 8:30-5/Monday-Friday 40 hrs |
University of California - San Francisco
Nov 02, 2024