University Job Title: Regulatory Manager, YCC
Bargaining Unit: None - Not included in the union (Yale Union Group)
Time Type: Full time
Duration Type: Regular
Compensation Grade: Clinical & Research
Compensation Grade Profile: Regulatory Manager, YCC (23)
Work Location: Medical School Campus
Worksite Address: 2 Church Street South Doctor's Building New Haven, CT 06519
Work Week: Standard (M-F equal number of hours per day)
Searchable Job Family: Clinical, Legal and Regulatory Affairs, Research Res Support, Research/Support
Total # of hours to be worked: 37.5
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI) and one of only 47 in the nation. Yale Cancer Center delivers the highest quality patient-centered care, achieves breakthrough discoveries and trains the future leaders in cancer science and medicine. There are over 190 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 11 Care Centers and trials are available within 20+ disease units. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer and harnesses the resources of the Yale School of Medicine and Smilow Cancer Hospital at Yale-New Haven to advance cancer research, prevention and patient care, as well as community outreach and education.
Reporting into the Clinical Trials Office, the Regulatory Manager will be responsible for management of the full life-cycle of clinical trial protocols for a specific disease team within the Yale Cancer Center; starting at the initial conception through study completion. He/she will manage all protocols within designated disease teams while working in close collaboration with the investigators, research nurses and data management and study coordination staff. The position will also manage and develop pre-activation (regulatory requirements, IRB approvals, sponsor reporting and amendment processing and termination reports).
1. Supervise the day to day work of assigned regulatory staff. Accomplish staff results by communicating job expectations, planning, monitoring and evaluating results. Perform coaching, mentoring, progressive counseling, and disciplining, as needed. Provide performance feedback. 2. Maintain staff by recruiting, selecting, onboarding and training regulatory staff within assigned DARTs. 3. Review status of initial approvals, amendments, renewals and post-approval issues within assigned DARTs to ensure regulatory compliance. Devise corrective action plans as needed to address instances of non-compliance. Ensure efficiency at each step in the process. 4. Under direction of the Director, Regulatory Affairs, assist with creation, revision and implementation of regulatory unit standard operating procedures (SOP). Train appropriate staff on new SOPs. 5. Maintain regulatory compliance and project management for single center Investigator-Initiated Clinical Trials where the IND is held by a Yale Investigator. Liaise with IND Coordinator to ensure compliance with Code of Federal Regulations. 6. Conduct routine monitoring of regulatory binders for Investigator-Initiated and Cooperative group studies within assigned DARTs. 7. Conduct quality assurance reviews of regulatory binders in preparation for internal and external audits and/ or inspections, as assigned by your supervisor. 8. Maintain professional knowledge on appropriate regulations and processes related to regulatory compliance in clinical trials. Attend educational workshops, review professional publications and disseminate knowledge to group.
Required Education and Experience
Bachelor’s Degree and 3 years of regulatory experience or an equivalent combination of education and experience.
Required Skill/Ability 1:
Demonstrated knowledge of regulatory affairs in areas of FDA-regulated clinical research, Investigational New Drug and Investigational Device submissions and management, audits, monitoring visits and NIH and NCI regulations and reporting requirements.
Required Skill/Ability 2:
Strong analytical and writing skills combined with the ability to communicate effectively and diplomatically in written and verbal forms with internal and external contacts (NIH, FDA, industry) faculty, researchers and staff at all levels while coordinating clinical trials.
Required Skill/Ability 3:
Demonstrated knowledge of oncology language and federal regulations involving human subjects. Proven ability to work successfully within a team environment and as an individual contributor. Ability to be flexible and adjust work schedule as needed to allow for team priorities to be met.
Required Skill/Ability 4:
Proven ability to manage several projects concurrently, while balancing competing priorities and deadlines. Extreme flexibility in work focus. Proven ability to switch among several different projects without any adverse effects.
Required Skill/Ability 5:
Proven ability to onboard, train and mentor junior regulatory staff. Previous experience in providing constructive feedback to direct reports and in escalating issues as necessary to Assistant Director of Regulatory Affairs. Ability to establish and assign the activities of multiple teams to accomplish study goals.
Preferred Education, Experience and Skills:
Experience supervising staff and demonstrating interpersonal skills highly preferred.
Drug Screen: No
Health Screening: No
Background Check Requirements
All candidates for employment will be subject to pre-employment background screening for this position, which may include motor vehicle, DOT certification, drug testing and credit checks based on the position description and job requirements. All offers are contingent upon the successful completion of the background check. Please visit www.yale.edu/hronline/careers/screening/faqs.html for additional information on the background check requirements and process.
The intent of this job description is to provide a representative summary of the essential functions that will be required of the position and should not be construed as a declaration of specific duties and responsibilities of the particular position. Employees will be assigned specific job-related duties through their hiring departments.
Affirmative Action Statement:
Yale University considers applicants for employment without regard to, and does not discriminate on the basis of, an individual’s sex, race, color, religion, age, disability, status as a veteran, or national or ethnic origin; nor does Yale discriminate on the basis of sexual orientation or gender identity or expression. Title IX of the Education Amendments of 1972 protects people from sex discrimination in educational programs and activities at institutions that receive federal financial assistance. Questions regarding Title IX may be referred to the University’s Title IX Coordinator, at TitleIX@yale.edu, or to the U.S. Department of Education, Office for Civil Rights, 8th Floor, Five Post Office Square, Boston MA 02109-3921. Telephone: 617.289.0111, Fax: 617.289.0150, TDD: 800.877.8339, or Email: email@example.com.