Yale University New Haven , CT 06501
Posted 4 weeks ago
1.Manages and monitors policies, practices and procedures of clinical research staff responsible for the implementation, management (including protocol updates / amendments), and quality conduct of clinical trials according to study protocols and Good Clinical Practice guidelines. 2. Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research staff.
Assigns and manages workload and provides estimates for individual project staffing needs using the Staffing Acuity Tool. Tracks data and metrics to determine appropriate personnel resource allocation based on study parameters. 3. Serves as a subject matter expert on protocol management and study subject recruitment.
Provides support and guidance to the study team to develop and maintain study specific materials (e.g., tracking logs, templates, monitoring tools, source documents, study binders, process manuals). 4. Collaborates with CTO Clinical Trials Project Manager and Principal Investigator (PI) on assessment and operational implementation of highly complex trials clinical research protocols within Oncology Disease Group, including feasibility, identifying accrual targets, resolving potential discrepancies and/or barriers to enrollment prior to study activation and patient enrollment process. Serves as a liaison to the study sponsor, regulatory agencies, investigators, and clinical teams. 5.
Ensures 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 regulations while ensuring participant safety. Includes assigning research support staff. 6. Manages oversight of protocol conduct and ensures that research site personnel and investigators, are conducting the study according to the protocols and Good Clinical Practice guidelines.
Stays abreast of federal and state regulations and local policies. Maintains a high degree of knowledge on these requirements and follows directives that may be required to ensure University compliance with congruency review and reporting requirements. 7. Develops, implements, and champions internal practices that ensure compliance with federal requirements. 8.
Serves as a critical resource before and during interim monitoring visits, internal audits and external audits/inspections. Works with study monitors to ensure compliance with study requirements. Analyzes and interprets reports/findings from retro/prospective audits with investigators and advises and monitors appropriate action plan.
Responsible for contributing to formal responses to audit and inspection report findings that relate to clinical operations findings. 9. Contributes to the review and refinement of CTO standard operating procedures (SOPs) and assists with SOP training. 10. Coordinates with Clinical Trials Project Manager to liaise between clinical and non-clinical related departments to resolve congruency issues in a timely manner for protocols/projects within their assigned Oncology Disease Group or Smilow Care Center. 11.
Coordinates, oversees and participates in meetings including but not limited to Pre-study Visits, Site Initiation Visits, Monitoring 12. Other duties as assigned.
Required Education and Experience
Bachelor's degree in a health-related discipline, or other related field and a minimum of five(5) years of experience in clinical trials research or the equivalent combination of education or experience.
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. For additional information on the background check requirements and process visit "Learn about background checks" under the Applicant Support Resources section of Careers on the It's Your Yale website.
This position is working a Hybrid schedule.
Yale Cancer Center is Connecticut's only cancer center designated as a Comprehensive Cancer Center by the National Cancer Institute (NCI). 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 300 clinical trials providing the most advanced cancer therapies at Smilow Cancer Hospital and in the 15 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.
Working under the direction of the Assistant Director for Clinical Operations, the Clinical Research Manager (CRM) is responsible for managing the Oncology Disease Group or Smilow Care Center staff members within the Clinical Trials Office (CTO) of Yale Cancer Center (YCC) and ensures appropriate infrastructure to conduct clinical trials in accordance with the study protocol and applicable policies and regulation while ensuring participant safety. This Position requires a strong emphasis on people management, including staff recruitment, retention, and performance management to ensure quality, accountability, and growth. Works within a multidisciplinary environment with colleagues both internally and externally in a cooperative manner exercising respectfulness and professionalism.
Preferred Education, Experience and Skills:
Experience supervising staff. Experience with oncology clinical trials strongly preferred.
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.