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University of Rochester Associate Director, Clinical Trials Coord Ctr Ops - 227954 in Rochester, New York

Associate Director, Clinical Trials Coord Ctr Ops Job ID 227954

Location

School of Medicine & Dentistry

Full/Part Time Full-Time

Favorite Job

Regular/Temporary Regular

Opening

Full Time 40 hours Grade 056 Neuro-Ctr Health & Tech/CTCC

Schedule

8 AM-5 PM; OCC WKNDS

Responsibilities

The Center for Health + Technology (CHeT) is a research organization within the University of Rochester that aims to enable anyone anywhere to receive care and participate in research. To do so, CHeT employs over 80 talented and diverse individuals to conduct unprecedented studies to evaluate new treatments and measures of disease. Over the past 30 years, CHeT has conducted over 100 studies and enrolled over 40,000 participants, leading to seven FDA-approved drugs for Parkinson’s disease, Huntington disease, and other neurological conditions.

GENERAL PURPOSE:

To support the Director, Clinical Trials Operations & Development of the Clinical Trials Coordination Center (CTCC), including in providing leadership and management of the clinical operations of the Clinical Trials Coordination Center (CTCC), consisting of approximately 60 to 70 team members, and the study groups it supports nationally and internationally. This includes the Parkinson Study Group (PSG); Huntington Study Group (HSG); and others. This role will assist with overseeing teams and ensuring maximum operational efficiency, resource utilization and overall regulatory compliance with all applicable state and federal regulations, licensing requirements, and professional standards pertaining to conducting clinical trials whether device, drug or biologic. The Associate Director will assist with handling the unique needs for the CTCC and requires considerable latitude of independent judgment as well as working within teams, CHeT leadership, and University dynamics. This role will oversee a team of highly skilled and efficient project and data management staff charged with continued focus on increasing efficiencies, improving quality control, and providing a robust training program. In partnership with the Director of the CTCC and other senior leaders, this role will oversee and ensure successful delivery and execution of clinical trial operations, including personnel management, finances, and regulatory compliance. Ensures that all institutional, local, state, and Federal Regulations, Good Clinical Practice (GCPs), ICH, and IRB requirements are met and that all sponsored programs within the CTCC are structured and resourced to continue to meet these expectations. This individual also provides expertise, guidance, and oversight to the operational units within the CTCC (clinical, regulatory, finance, quality, training, information systems, etc.) including but not limited to activities necessary to support:

SPECIFIC RESPONSIBILITIES:

Oversee all aspects of clinical trial operations, including project management, data management, monitoring, project prioritization, resource allocation, and day-to-day operations efficiency. Plan and direct the administrative and programmatic support for activities in order to effectively manage available resources (staffing, space, supplies, and office equipment). Develop and evaluate ongoing training programs. Oversee the structure and processes of the CTCC and other committees established to monitor the performance and quality of the CTCC’s clinical research operations (25%)

Recruit, develop, train, mentor, evaluate, and retain strong talent; manage various personnel issues within the CTCC. Represent the Principal Investigators or Program Directors to outside organizations and sites involved in the research, the clinical trials, and other interested parties. Acts as a resource in working with other departments of the University and Medical Center. Serve as a member of various support services committees. Oversee the development, implementation, and routine updating of Standard Operating Procedures (SOPs) to ensure consistent, safe, and efficient management of clinical trials and continuous improvements in the integrity of clinical trial activities. (20%)

Support improvements in infrastructure, technologies, operating systems, and processes for clinical trials management to maximize day-to-day operations efficiency. Assists Principal Investigators in applying for renewal or supplemental grants and programs for funding and in preparing progress reports. Administrative management of the electronic systems utilized to monitor performance and efficiency and participation in the development or the selection of systems that would impact the clinical trials operations and conduct of clinical trials. (10%)

Facilitate transparency into CTCC operations – e.g., self-serve reporting for client, timeline/resource dashboard to manage project timeline and optimize resource allocation. Develop and implement innovative programmatic, strategic, and operational approaches to advance the quality and efficiency of Phase I-IV clinical trials and clinical research. Facilitate integration of CTCC’s central research administration initiatives and support initiatives to expand clinical research support services enterprise-wide as appropriate. Represent the CTCC on committees and task forces. Serve as liaison to advance clinical trial interests including participation in community outreach. (10%)

Interface with CHeT Senior Leadership, Principal Investigators, Sponsors, and other representatives regarding operations of multi-center clinical research trials. Provide oversight for generation of monthly reports including but not limited to performance, accrual, monitoring, time to activation, audit visits, and financial performance. Ensure accuracy of clinical trial information in all clinical trial systems and databases, and tracking systems. Ensure quality, timely, and accurate data and report submission. Facilitate the expansion of programs across CTCC’s network and affiliate sites in conjunction with departmental leadership. (10%)

Direct and coordinate all aspects of multi-center clinical research trials, oversee entire study teams, internal and external, including study sponsors, clinical trial sites, pharmacy department, clinical and research laboratories, contract research organizations, study principal investigators, study medical monitors, biostatistics department, data management unit, and administration/fiscal unit. Oversee the clinical data management (CDM) activities for the entire life cycle of multiple clinical trials in Phases I-III, from protocol development through database lock. Direct and oversee the activities of staff on study teams. Interact with Principal Investigators and senior management. (10%)

Work with department’s Financial Controller and finance and administration teams to monitor and evaluate overall CTCC finances, including project scope and budgets, change orders/contract amendments, and overall resources (staffing and space). (5%)

Liaise with in-house staff regarding Quality Assurance issues, to ensure CTCC regulatory documents are in compliance with Federal Regulations, Good Clinical Practice and Standard Operating Procedures. (5%)

Additional projects and responsibilities as needed. (5%)

REQUIREMENTS:

  • Masters degree or higher in health or life sciences related field, Business Administration, or equivalent experience in a specialty suited to the position

  • A minimum of 6 years’ experience in clinical research, biopharma drug development/ and/or healthcare industry experiences. At least 10+ years of experience in the industry strongly preferred

  • Minimum of 6 years of demonstrated, effective strategic planning; analytical problem solving and decision making; managerial and leadership skills and experience; or equivalent combination of experience and education

  • Strong organizational, interpersonal, presentation and communication skills, including written communications

  • Ability to model leadership skills of professionalism, positive attitude, team building, good judgment and respect

  • Ability to manage multiple projects, organize and prioritize work and perform several tasks simultaneously to meet deadlines and work effectively with people at all levels of the organization

  • Good understanding of regulatory requirements (e.g., GCP, HSPP, ICH) and Audit readiness

    How To Apply

All applicants must apply online.

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