System One
Location
New Haven, CT | United States
Job description
Title: Assistant Director, Clinical Trials Operations
Location: New Haven, CT (hybrid)
Schedule: M-F 37.5 hours, occasional evening and weekend hours
Type: Direct Hire
Leading Research Institute located in CT is hiring a Assistant Director, Clinical Trials Operations with 5 + years industry experience. If you want to be a part of this groundbreaking work, please apply!
Responsibilities:
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.
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.
Directs and oversees the clinical trial operation function for 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. 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 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. 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. 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.
Requirements:
Master’s degree in a health-related discipline, or other related field. Experience with oncology clinical trials strongly preferred.
ACRP/SOCRA (or equivalent) certification preferred. Willingness to obtain within one year.
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.
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, senior management, and other team members including those geographically dispersed.
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.
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.
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.
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.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.
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