Director, Clinical Research Support Services - Boston Children's Hospital

The Director of Clinical Research Support Services reports directly to the Vice President, Clinical Research Operations. The Director oversees, evaluates, and develops a full array of support services and resources for efficient, safe, compliant, and high-quality execution of clinical research studies at BCH (from protocol development to close-out). The CR Support program supports a full spectrum of studies, from high-risk interventional trials with experimental drugs and devices to minimal-risk observational clinical research studies. In close collaboration with the Director of Process Improvement, the Director is responsible for continuously assessing the needs of the clinical research community and modifying services in response to these needs.

The Director of Clinical Research Support Services will be responsible for: 

• Providing evaluation and oversight of a full range of clinical research support services to meet the needs of investigators and study teams throughout the study start-up, implementation, and close-out phases.
• Collaborating with BCH Nursing leadership to leverage the clinical resources of BCH PPSQ, integrating both clinical and research standards to support the care of research participants, ensuring their physical safety, care, and comfort.
• Working closely with the Director of Process Improvement and the Director of Regulatory and Education to continuously modify and improve support capabilities, enhancing the efficiency of clinical research service delivery while ensuring high levels of safety and regulatory compliance.
• Promoting and fostering a high-quality customer service experience for all customers, both internal and external, and seamlessly integrating with other teams and departments across the hospital to achieve results.
• Participating in strategic planning and implementing new initiatives and programs aimed at advancing the quality, efficiency, and impact of clinical research at BCH.
• Current CR Support services include:
  • Study coordination and project management support
  • Regulatory support available for IND, IDE, and N=1 studies
  • Regulatory, data, and safety monitoring support for BCH investigator-initiated trials (single and multi-center studies)
  • Data management
  • Clinical research nursing support
  • Advance Practice Registered Nursing support
  • Specimen Handling Support
  • Metabolism & Nutrition Support
  • Oversight of Facilities: ambulatory units (Boston ETU and Waltham ETU)
    • Boston ETU and Waltham ETU
    • DXA Research

To qualify, you must have: 

• Bachelor's degree in Public Health, Clinical Investigation or Nursing, Master's preferred. 
• At least eight years of experience in clinical research operations in an academic medical center or in the pharmaceutical, biotechnology, or contract research industry.
• A minimum of five years of management experience and comprehensive knowledge of federal regulations.
• Experience supporting FDA-regulated drugs and/or devices and previous experience interacting with FDA or other regulatory health authorities preferred. 
• Deep expertise in the conduct and support of clinical research studies.
• Considerable experience leading multifaceted, multidisciplinary clinical research teams.
• Ability to clearly understand and foresee the needs of clinical research investigators and teams and be responsive to them while designing and modifying existing support services.
• Excellent interpersonal skills to effectively communicate with cross-functional teams, including staff at all levels of the organization, including both clinical and non-clinical personnel.
• Exceptional problem-solving and negotiation skills.
• Ability to effectively conduct meetings, both formal and informal, including departmental and clinical user meetings
• Ability to successfully negotiate and collaborate with others of different skill sets, backgrounds, and levels within and external to the organization.
• Ability to read and comprehend regulatory and technical documents and data.

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