Research Coordinator (FT), Orthopaedics - Clinical Trials

📁
Research/Science
📅
190001DD Requisition #

Performs a wide range of tasks associated with conducting clinical trials and research studies while managing multiple research protocols, providing guidance to other members of the research team, and supporting the overall direction of research in the department.

 

Responsibilities:

  1. Organizes and manages clinical trials and research studies. Provides expertise and guidance to the research team and investigators.
  2. Conducts protocol reviews to assess the feasibility of potential studies. Seeks out new research opportunities. Participates in study site selection activities.
  3. Prepares and submits regulatory documents to study sponsors and any applicable regulatory agencies.
  4. Works with study investigators to develop recruitment and screening procedures. Designs and develops recruitment documentation.
  5. Composes informed consent forms and protocol abstracts. Creates other study documents and study management tools.
  6. Maintains study and regulatory documentation. Monitors and manages compliance with regulatory requirements for other members of the research team.
  7. Carries out study visit tasks and procedures, some of which may require being on call. Arranges required tests and other appointments. Interviews study participants about their medical history, medications, adverse events, demographics, and quality of life issues.
  8. Communicates with participants throughout the course of the study.
  9. Travels to investigator meetings and study training.
  10. Provides education and support to study participants and their families.
  11. Acts as liaison between principal investigators, regulatory agencies, D-H stakeholders, and study participants to resolve problems.
  12. Designs, establishes, and conducts training programs for clinical research staff.
  13. Participates in the preparation of grants for funding department research.
  14. Works with others in the financial management of the department’s research program.
  15. Performs other duties as required or assigned.
Minimum Qualifications:
  • Bachelor’s degree with 5 years of relevant experience, or the equivalent in education and experience, required.
  • Master’s degree preferred.
  • Excellent organizational, writing, and office software skills required.
     
Required Licensure/Certification Skills:
  • Certification through the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) required.

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