Director, Clinical Research

Company: Boston Children'S Hospital
Location: Boston
Posted on: March 20, 2023

Job Description:

Job Posting Description The Director, Clinical Research shall be responsible for:

• Providing administrative and clinical leadership for the Clinical Trials Unit (CTU) as well as providing services for the conduct of research.
• Coordinating clinical research activities for investigator-initiated as well as foundation, federal and industry sponsored research and regulatory activities conducted in the, Department of Psychiatry & Behavioral Sciences.
• Providing oversight of IRB submissions from regulatory staff, including: initial submissions, research protocols, informed consents, HIPAA authorizations, investigator's brochures, advertising, continuing reviews, protocol amendments and communications, and unanticipated problem/adverse events, protocol deviations, and other applicable submissions.
• Providing leadership in the ongoing quality improvement in the Clinical Trial Unit (CTU), assuring quality management practices are in place and maintained appropriately.
  • Assisting the Chair of Research, Department of Psychiatry & Behavioral Sciences on in site feasibility assessments and strategic planning for the growth of departmental clinical research.
  • Providing random and scheduled audits of CTU studies, managing audit findings appropriately with CTU coordinators.
  • Seeking out internal and external expertise, as necessary, related to research matters; actively develops strategic relationships with foundation and industry partners to facilitate new and innovative clinical trials at Boston Children's Hospital.
  • Collaboratively working with other clinical trials manager(s), research staff, and Boston
  • Participating in bi-weekly meetings with senior clinical trials team members and the Chair of Research to discuss operational issues.Trains/Supervises CTU staff, junior faculty, and residents and fellows conducting clinical research to include: assisting with the development of Standard Operating Procedures (SOPs); orientation training, educational training, and overall training of personnel
  • Training/Supervising CTU staff, junior faculty, and residents and fellows conducting clinical research to include: assisting with the development of Standard Operating Procedures (SOPs); orientation training, educational training, and overall training of personnel
  • Providing daily coordination/supervision of CTU staff.
  • Routinely reviews applicants for CTU positions, conducts interviews, and makes recommendations regarding suitability of candidates
  • Providing career development to clinical research coordinators, including CRC ACRP certification.
  • Recruiting and retains high-profile researchers to the CTU.
  • Providing leadership in development of training programs for coordinators and investigators, and other related organizations and committees;
  • Providing research training to investigators and clinical coordinators routinely
  • Attending and participates in Department of Psychiatry & Behavioral Sciences staff meetings and conferences.
  • Attending scientific and clinical research meetings as well as other events related to enhancing the scope and skills of the clinical trials unit.
    In order to qualify you must have:
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    • Current MA license as a Registered Nurse
    • A Master's degree, Ph.D. preferred but not required
    • 10 years human subject clinical research experience, including investigational drugs
    • and/or medical devices research experience.
    • Minimum of five years nursing experience.
    • Previous supervisory experience
      
      Boston Children's Hospital offers competitive compensation and unmatched benefits including flexible schedules, affordable health, vision and dental insurance, child care and student loan subsidies, generous levels of time off, 403(b) Retirement Savings plan, Pension, Tuition and certain License and Certification Reimbursement, cell phone plan discounts and discounted rates on T-passes. Experience the benefits of passion and teamwork.
      
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Keywords: Boston Children'S Hospital, Boston , Director, Clinical Research, Executive , Boston, Massachusetts