Yale Cancer Center is seeking a dynamic Assistant Director, Clinical Trial Operations to lead a portfolio of clinical research oncology disease groups in the Clinical Trials Office. Working under the Director of CTO Operations, the Assistant Director will assist cancer center leadership in achieving its research mission and strategic initiatives, by serving as a direct link between the clinical research disease team staff, the CTO administration, and Smilow Cancer Hospital. The incumbent will provide consistent leadership for the day-to-day operations of the clinical research disease programs, ensure competent and standardized staff practices, and coordinate strategies to enhance interdisciplinary communication and collaboration.
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Essential Duties
Directs and oversees the clinical trial operation function for a Yale Cancer Center, Clinical Trials Office disease team portfolio. Creates functional strategies and specific objectives for the assigned disease team portfolio and develops budgets, policies and procedures to support the functional infrastructure. Provides strategic input to leadership related to short and long-term planning for the Cancer Center Clinical Trials Office. Develops and implements short and long-term objectives for assigned portfolio related to productivity, compliance, communication and patient satisfaction. Designs and implements process improvement initiatives to meet goals and objectives. Manages and directs the ongoing and day to day operations of the assigned disease team portfolio staff, consisting of Clinical Trials Team Managers, Clinical Research Nurses, Clinical Research Coordinators, and Clinical Research Assistants. Establishes priorities with appropriate timelines for to ensure efficient and effective operations. Deploys resources among teams in collaboration with faculty DART leaders. Ensures the competency of staff across each disease team through effective onboarding, and ongoing training programs, coaching and mentoring. Ensures full compliance of clinical research operations within the span of authority of the position. Prepares responses to FDA audit findings. Designs, implements, and monitors corrective action plans. Drives operational changes to achieve best in class operations throughout the organization based on the findings of internal or external auditors, confirming full compliance of requirements of Clinical Trials Reporting Program (CTRP). Manages and directs the data management functions inherent to oncology clinical research of assigned disease team portfolios, including effectively and efficiently collaborating with external sponsors on requisite data collection platforms. Oversees the activities necessary to ensure effective and timely activation of clinical trials within disease team portfolio from stage of protocol concept through obtaining open to accrual status. Utilizes data to effectively monitor the process for protocol activation.
Required Education and Experience
Bachelors Degree in related field and five years of related experience.
Required Skill/Ability 1:
Demonstrated mastery of the phases of clinical trials, and the regulatory, administrative, and operational functions necessary to support the clinical research study life cycle in a safe and compliant manner. Provide leadership and promote collaboration with staff, faculty, senior management, and other team members including those geographically dispersed.
Required Skill/Ability 2:
Proven ability to manage and evaluate orientation, education and professional developmental needs for research staff using the CFR, GCP, ICH, protocol requirements, and research professional resources with the objective of developing and maintaining high functioning of clinical research experts.
Required Skill/Ability 3:
Ability to conduct periodic reviews of the clinical trial portfolio and evaluate the research infrastructure to ensure best use of resources and clinical trial accrual. Demonstrated experience auditing and coordinating audits of systems and practices to ensure quality and regulatory compliance.
Required Skill/Ability 4:
Understanding of clinical research operations. Ability to assist with achieving financial and, operations targets for assigned research areas through participation in program planning, budget development, and development of operational practices.
Required Skill/Ability 5:
Demonstrated communication, leadership and team building skills: evidence of this should include resource management, effective problem solving, conflict resolution, motivating others as individuals and as groups, and planning, organizing, and directing the activities of others.
Preferred Education, Experience and Skills:
Master’s degree in a health-related discipline, or other related field. Demonstrated experience with oncology clinical trials strongly preferred.
Preferred Licenses or Certifications:
ACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year.
Weekend Hours Required?
Occasional
Evening Hours Required?
Occasional
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. 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.
Health Requirements
Certain positions have associated health requirements based on specific job responsibilities. These may include vaccinations, tests, or examinations, as required by law, regulation, or university policy.
Posting Disclaimer
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.