1. Manages and monitors policies, practices and procedures of licensed and unlicensed staff in their assigned translational working group (includes C&T and M&P staff). 2. Ensure infrastructure to conduct clinical trials by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies and regulation while ensuring participant safety. Includes assigning nursing and research support staff to the disease team specific clinical trials. 3. Hires, trains, supervises and evaluates staff providing direction, training, support on a variety of research topics, including but not limited to: Informed Consent, enrolling study subjects, data management and monitoring/auditing of studies. 4. Collaborate with Therapeutic Working Group Leader (TWG) and Principal Investigator (PI) on assessment and implementation of highly complex trials for the research team. Includes identifying accrual targets, study activation timelines and metrics and resolving potential discrepancies and/or barriers to enrollment by prior to study activation. 5. Implements and manages internal practices of assigned translational working group that ensure compliance with University and federal requirements. 6. Manage oversight of protocol conduct and ensure that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines. Monitors federal and state regulations for new guidance, updates, or policies. Maintains a high degree of knowledge on these requirements to determine actions and follow directives that may be required to ensure University compliance with congruency review and reporting requirements. 7. Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring visits, Multi-disciplinary Team meetings, staff meetings. 8. Liaison between the Grants and Contracts offices, investigators, and business managers to resolve congruency issues in a timely manner for projects within their assigned translational working group 9. Liaison between clinical and non-clinical related departments to resolve congruency issues in a timely manner for protocols/projects within their assigned translational working group.
Required Skill/ability 5: Demonstrated ability to report on the status of project deliverables and draft and submit project updates to Yale team and study sponsor.
Posting Position Title: Manager, Clinical Trial Disease Team
Required Skill/ability 3: Strong knowledge of Good Clinical Practice guidelines. Proven experience interpreting federal, state, Yale University and sponsor policies and regulations. Experience with interpreting complex oncology clinical trial protocols and federal, state, local guidelines.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Clinical Trials Team Manager
Required Skill/ability 1: Proven ability to manage and monitor the policies, practices and procedures of licensed and unlicensed staff. Proven ability to develop specific short- and long-term objectives for staff.
Required Skill/ability 4: Proven ability to manage several projects concurrently, while balancing competing priorities and deadlines. Extreme flexibility in work focus. Ability to switch among several different projects without any adverse effects.
Required Skill/ability 2: Demonstrated ability to ensure appropriate infrastructure by evaluating the clinical, physical, technological, and staff resources required to ensure each clinical trial can be conducted in accordance with the study protocol, applicable policies, and regulation while ensuring participant safety.
Bachelor's degree in a relevant academic/scientific field and a minimum of 4 years of experience in clinical trials research or the equivalent combination of education or experience.
Internal Number: 65999BR
About Yale University
Yale University is an American private Ivy League research university located in New Haven, Connecticut. Founded in 1701 in the Colony of Connecticut, the university is the third-oldest institution of higher education in the United States.