Assistant Director, Clinical Trials Operations

19-Jan-2024

Comprehensive Cancer Center – Clinical Trial Operations

86249BR

University Job Title

Assistant Director, Clinical Trials Operations

Bargaining Unit

None – Not included in the union (Yale Union Group)

Compensation Grade

Clinical & Research

Compensation Grade Profile

Assistant Director, Clinical Trials Operations (M6)

Wage Ranges

Click here to see our Wage Ranges

Searchable Job Family

Administration, Clinical, Research Res Support, Research/Support

Total # of hours to be worked:

37.5

Work Week

Standard (M-F equal number of hours per day)

Work Location

Medical School Campus

Worksite Address

300 George Street
New Haven, CT 06511

Position Focus:

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. 

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.  

Essential Duties

•    Directs and oversees the clinical trial operation function for a Yale Cancer Center, Clinical Trials Office oncology disease group. Creates functional strategies and specific objectives for the assigned oncology disease group 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.  •    Responsible for recruiting, hiring, career development, performance evaluations, disciplinary actions, and day-to-day supervision of the clinical research professionals (clinical research managers, clinical trials project managers, data coordinators, clinical research coordinators, and clinical research nurses.  •    Establishes priorities with appropriate timelines for to ensure efficient and effective operations. Deploys resources among teams in collaboration with faculty oncology disease group leaders. •    Partners with the CTO Quality and Education unit to ensure proper education and training of clinical research professionals (data coordinators, clinical research coordinators, clinical research nurses and clinical research managers) as it pertains to clinical facing responsibilities. In partnership with the CTO Quality and Education unit, develops, implements, and evolves Oncology specific role-based curriculum for new employees.  •    Ensures full compliance of clinical research operations within the span of authority of the position. Prepares responses to 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

Bachelor’s degree in a health-related discipline and a minimum of eight (8) years of clinical research experience with four (4) years of clinical trials research operations experience required. Three (3) years of supervisory experience required.

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. 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. 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

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.

COVID-19 Vaccine Requirement

The University maintains policies pertaining to COVID-19. All faculty, staff, students, and trainees are required to comply with these policies, which may be found here:
https://covid19.yale.edu/health-guidelines

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.

EEO Statement:

University policy is committed to affirmative action under law in employment of women, minority group members, individuals with disabilities, and protected veterans. Additionally, in accordance with Yale’s Policy Against Discrimination and Harassment, and as delineated by federal and Connecticut law, Yale does not discriminate in admissions, educational programs, or employment against any individual on account of that individual’s sex, sexual orientation, gender identity or expression, race, color, national or ethnic origin, religion, age, disability, status as a special disabled veteran, veteran of the Vietnam era or other covered veteran.

Inquiries concerning Yale’s Policy Against Discrimination and Harassment may be referred to the Office of Institutional Equity and Accessibility (OIEA).

Note

Yale University is a tobacco-free campus