1. Provide goal-oriented leadership for the development of strategic initiatives to support current and future CTO services that facilitate the YCC mission and its research objectives. Develop strategies to increase clinical trial enrollment for the Smilow Cancer Hospital Care Centers (SCHCC), with special focus on affiliate hospitals located throughout the United States.2. Oversee the assessment, evaluation, reporting, and facilitation of the ability of each YCC affiliate and SCHCC site to support the conduct of clinical trials in accordance with the study protocols, YCC policies, GCP/ICH guidelines, and state and federal requirements.3. Oversee the identification and problem resolution of potential discrepancies and/or barriers to enrollment by affiliate centers prior to site or study activation and collaborate with the Principal Investigator to address such issues.4. Develop and implement policies and procedures, monitoring and/or auditing guidelines, operations manuals, databases, training tools and materials, and needed infrastructure to ensure compliance with study protocols and international, national and institutional practice standards and guidelines, regulatory requirements, applicable laws and Yale policies, in collaboration with the Associate Director and other senior leadership.5. Ensure the conduct of initiation visits, teleconferences and supplemental training as necessary to ensure accurate and timely data submission, review of electronic data submission and follow-up of discrepant data.6. Ensure adherence of on-site trial monitoring or auditing schedules in accordance with YCC's data and safety monitoring plan or policy for trials conducted at affiliate sites, St. Raphael's and SCHCC sites.7. Oversee and ensure staff competency development across each disease team through effective onboarding, and ongoing training programs, coaching and mentoring.8. Develop specific short- and long-term objectives for assigned CTO staff. Establish priorities with appropriate timelines for the initiation of clinical research that meet the standards for the Institutional Review Board (IRB), pharmaceutical companies, and the National Cancer Institute, Cancer Center Support Grant.9. Oversee the implementation and measurement of CTO clinical research quality control activities.10. Facilitate the adoption of new protocols in managed locations through tracking mechanisms, resource needs assessment, and all other related activities required.11. Project and identify appropriate staffing to provide adequate coverage of research related activities for all managed locations.12. Create and manage an environment that empowers and expects clinical research staff to participate in identifying and meeting their professional education goals. Establish educational priorities as they relate to research training, which includes coordinating an orientation process for new employees.13. Ensure compliance of clinical trials billing, in collaboration with the Finance Department and CTO research nurse manager(s).14. Participate in National Cancer Institute clinical research initiatives. Represent YCC through participation in forums and organizations as they relate to clinical research activities.15. Develop communication strategies to support goals and expected results and demonstrates ability to remain objective and professional in stressful, sensitive, or difficult interpersonal situations.
Preferred Education: Master's Degree in a bio-sciences related field. A health care professional (e.g., registered oncology nurse, clinical pharmacist, etc.) Oncology research experience. Previous experience monitoring and/or coordinating multi-center clinical trials from an academic or industry perspective. 5 years' experience in a related management role.
Preferred Education, Experience and Skills: Master's Degree in a bio-sciences related field. A health care professional (e.g., registered oncology nurse, clinical pharmacist, etc.) Oncology research experience. Previous experience monitoring and/or coordinating multi-center clinical trials from an academic or industry perspective. 5 years' experience in a related management role.
Required Skill/ability 5: Ability to manage several projects concurrently including those assigned to project management (PM) staff, balancing competing priorities and deadlines. Extreme flexibility in work focus; ability to switch among several different projects without any adverse effects. Ability to organize and prioritize work of all PM and regulatory staff and handle high volume of work.
Posting Position Title: Regional Assistant Director, Clinical Trials Ops
Required Skill/ability 3: Understanding of the requirements of clinical trials with regard to staffing, systems and processes. Excellent communication, coordination and integration skills with experience in complex, multi-institutional collaborative models, or matrix system.
Work Week: Standard (M-F equal number of hours per day)
University Job Title: Regional Assistant Director, Clinical Trials Ops
Required Skill/ability 1: Extensive knowledge in clinical research, clinical trials management and regulatory affairs. Experience with implementing and monitoring research protocols in a clinical setting.
Required Skill/ability 4: 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.
Required Skill/ability 2: Valid and current driver's license required. Availability to travel extensively on a regional and national basis.
Bachelor's Degree in relevant technical field and six years of related experience; or an equivalent combination of education and experience.
Internal Number: 66803BR
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.