Clinical Trials Team Regional Manager
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute. The YCC 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, available within 20+ disease units, which provide the most advanced cancer therapies at Smilow Cancer Hospital and in the 11 Care Centers located throughout the State. Yale has been at the forefront of understanding the fundamental mechanisms of cancer biology and in developing effective therapies for the treatment of cancer, which are offered to patients throughout the Yale New Have/Smilow Cancer Hospital Network.
Working under the direction of the Assistant Director for Clinical Research Operations for the Smilow Cancer Hospital Network, this position manages Care Center staff at multiple Centers located in Southwestern Connecticut. Currently these include Trumbull, Greenwich and Fairfield. The position ensures appropriate trial selection and infrastructure to conduct clinical trials in accordance with the study-specific protocols and applicable policies and regulations. Collaborates with hospital and University administrators in developing, implementing and maintaining Center based research support infrastructure. Collaborates with New Haven based DART Leader, CTTM and Principal Investigators on assessment and implementation of complex clinical trials for the Care Centers and affiliated hospitals. Coordinates with hospital and University administrators and manages oversight of protocol conduct to ensures that site clinical teams, investigators and research personnel are conducting the study per the protocols, Good Clinical Practice guidelines and applicable University policies and regulations. Provides support when needed in clinic, functioning as primary CRN/CRC when required. Functions as a supporting role for nursing in-services on new protocols when needed in primary care centers. Monitors federal and state regulations for new guidance, updates, or policies and implements changes in assigned Centers when required.
- 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).
- 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.
- 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.
- 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.
- Implements and manages internal practices of assigned translational working group that ensure compliance with University and federal requirements.
- 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.
- 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.
- 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 group9. 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 Education and Experience
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.
Required Skill/Ability 1:
Valid and current driver's license required for travel within state. May also be required to travel to adjacent state locations. Demonstrated ability to report status of project deliverables and draft and submit project updates to Yale team and study sponsor. Proven ability to manage several projects concurrently, while balancing competing priorities and deadlines.
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 at assigned locations in accordance with the study protocol, applicable policies, and regulation while ensuring participant safety.
Required Skill/Ability 3:
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 assigned locations, assess protocol/practice deviations and implement corrective and preventive action plans when necessary.
Required Skill/Ability 4:
Strong knowledge of Good Clinical Practice guidelines and applicable University policies pertaining to human research. Proven ability to interpret federal, state, University and sponsor policies and regulations. Proven ability to interpret complex oncology clinical trial protocols, assessing protocol compliance and federal, state, local guidelines.
Preferred Education, Experience and Skills:
Associate's, Bachelor's or Master's in Nursing with 4 or more years of clinical research experience.
Preferred Licenses or Certifications:
Licensed Registered Nurse in Connecticut. Oncology Nurse Certification (OCN, AOCN, AOCNS, or AOCNP), and Cancer Clinical Research Personnel Certification (CCRP), or an Association of Clinical Research Professionals certification (CRCC or CTIC).
Weekend Hours Required?
Evening Hours Required?
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.
Additional Background or Health Screening Requirements
Selected incumbent must have successful completion of a DMV check, a valid driver’s license and a car available.
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.
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