Director, Clinical Research Support Services

2 weeks ago

Boston, United States Boston Children's Hospital Full time
Job Posting Description

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.
#LI-Hybrid

  • Director, Clinical Research Support Services

    3 weeks ago

    Boston, United States Children's Hospital Boston Full time

    Children's Hospital Boston Director, Clinical Research Support Services Boston , Massachusetts Apply Now 75493BRJob Posting Title:Director, Clinical Research Support ServicesDepartment:Research-Clinical Research Core ProgramsAutoReqId:75493BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:The Director of...

  • Director, Clinical Research Support Services

    1 month ago

    Boston, United States Children's Hospital Boston Full time

    75493BRJob Posting Title:Director, Clinical Research Support ServicesDepartment:Research-Clinical Research Core ProgramsAutoReqId:75493BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:The Director of Clinical Research Support Services reports directly to the Vice President, Clinical Research Operations. The...

  • Director, Clinical Research Support Services

    3 weeks ago

    Boston, United States Children's Hospital Boston Full time

    75493BRJob Posting Title:Director, Clinical Research Support ServicesDepartment:Research-Clinical Research Core ProgramsAutoReqId:75493BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:The Director of Clinical Research Support Services reports directly to the Vice President, Clinical Research Operations. The...

  • Director, Clinical Research Support Services

    2 weeks ago

    Boston, United States Children's Hospital Boston Full time

    75493BRJob Posting Title:Director, Clinical Research Support ServicesDepartment:Research-Clinical Research Core ProgramsAutoReqId:75493BRStatus:Full-TimeStandard Hours per Week:40 Job Posting Category:ResearchJob Posting Description:The Director of Clinical Research Support Services reports directly to the Vice President, Clinical Research Operations. The...

  • Clinical Research Coordinator I

    2 months ago

    Boston, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionClinical Research Coordinator IThe CRC I will ensure that quality research is conducted at the assigned investigative sites in accordance with the sponsor protocol, FDA Regulations, and ICH/GCP guidelines and to provide the best quality data to the sponsor. The CRC I will also ensure study enrollment meets or exceeds...

  • Director, Account Services, Clinical Trials Research

    4 weeks ago

    Boston, United States Dana-Farber Cancer Institute Full time

    Overview This role will report to the Vice President of Research Informatics Operations (RIO). RIO is a division of the Dana-Farber Cancer Institute (DFCI) Informatics and Analytics department (I&A) led by the Chief Data & Analytics Officer (CDAO) of Dana-Farber. RIO is a subdivision of the DFCI Research Informatics and Analytics department led by the...

  • Site Director

    2 months ago

    Boston, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionSite DirectorThe Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations and ICH/GCP...

  • Site Director

    3 weeks ago

    Boston, United States DM Clinical Research Full time

    Job DescriptionJob DescriptionSite DirectorThe Site Director will ensure study enrollment to meet or exceed Sponsors' expectations, and company goals are achieved on a timely basis. The site director will also ensure that quality research is conducted at assigned investigative sites in accordance with the sponsor protocol, FDA Regulations and ICH/GCP...

  • Associate Director, Clinical Research Program

    1 month ago

    Boston, United States Dana-Farber Cancer Institute Full time

    Overview The Associate Director, Clinical Research Program will oversee all clinical trials and translational research operations, regulatory and compliance within the Multiple Myeloma Disease Program. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient...

  • Associate Director, Clinical Research Program

    3 weeks ago

    Boston, United States Dana-Farber Cancer Institute Full time

    Overview The Associate Director, Clinical Research Program will oversee all clinical trials and translational research operations, regulatory and compliance within the Multiple Myeloma Disease Program. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient...

  • Associate Director, Clinical Data Management

    5 days ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    4 days ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Companys Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH) Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Associate Director, Clinical Data Management

    5 days ago

    Boston, United States Clinical Dynamix Full time

    ASSOCIATE DIRECTOR CLINICAL DATA MANAGEMENT (This role is based in Company's Waltham, MA headquarters. Their office-based employees follow a hybrid in-office schedule. 2 Days a week in office (3 days WFH)Reporting to the Senior Director, Clinical Data Management, the Associate Director, Clinical Data Management will define and lead the clinical data...

  • Clinical Research Project Management Specialist

    6 days ago

    Boston, United States Boston Medical Center Full time

    ***: Under the supervision of the Director of the Wellness and Recovery After Psychosis (WRAP) Program, the Project Management Specialist will provide complex administrative and research project management for the WRAP Program. This specific Project Management Specialist position will involve managing the clinical trials and other clinical research...

  • Clinical Research Coordinator

    1 month ago

    Boston, United States Massachusetts General Hospital(MGH) Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT:  The Recovery Research Institute (RRI) within the Massachusetts General Hospital (MGH) Department of Psychiatry is recruiting a full-time clinical research coordinator II to June 2024. The person who fills this role will help coordinate a study, supported by a contract with the Bureau of Substance Addiction Services...

  • Clinical Research Coordinator

    3 weeks ago

    Boston, United States Massachusetts General Hospital(MGH) Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT:  The Recovery Research Institute (RRI) within the Massachusetts General Hospital (MGH) Department of Psychiatry is recruiting a full-time clinical research coordinator II to June 2024. The person who fills this role will help coordinate a study, supported by a contract with the Bureau of Substance Addiction Services...

  • Clinical Research Coordinator

    3 weeks ago

    Boston, Massachusetts, United States Massachusetts General Hospital(MGH) Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The Recovery Research Institute (RRI) within the Massachusetts General Hospital (MGH) Department of Psychiatry is recruiting a full-time clinical research coordinator II to June 2024. The person who fills this role will help coordinate a study, supported by a contract with the Bureau of Substance Addiction Services (BSAS)...

  • Clinical Research Coordinator

    1 month ago

    Boston, Massachusetts, United States Massachusetts General Hospital(MGH) Full time

    GENERAL SUMMARY/ OVERVIEW STATEMENT: The Recovery Research Institute (RRI) within the Massachusetts General Hospital (MGH) Department of Psychiatry is recruiting a full-time clinical research coordinator II to June 2024. The person who fills this role will help coordinate a study, supported by a contract with the Bureau of Substance Addiction Services (BSAS)...

  • Business Development Manager- Primate Research Services

    1 month ago

    Boston, United States RPM ReSearch Full time

    Job DescriptionJob Title: Business Development DirectorLocation: Boston Regional.Job Summary: The Director of Business Development will have the responsibility for growing, maintaining, and fostering sales in a regional territory. They will work as part of a team to help meet sales goals and work through a CRM to augment existing sales practices and...

  • Clinical Trial Manager

    4 weeks ago

    Boston, United States Clinical Dynamix Full time

    Responsible for oversight, coordination, and execution of clinical trials in support of clinical operations programs in Phases I‐IV of development.RESPONSIBILITIESClinical Operations team member: works closely with the Sr. CTM and/or Director of Clinical Operations and is responsible for oversight, planning, and execution of assigned clinical studies,...