Associate Research Coordinator (FT), Orthopaedics Research - Days

180001IE Requisition #
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  1. Organizes and manages clinical trials and research studies. Conducts preliminary protocol reviews to assess the feasibility of potential studies. Participates in study site selection activities.
  2. Prepares and submits regulatory documents to study sponsors and any applicable regulatory agencies. Maintains a working knowledge of relevant Federal Drug Administration (FDA) and International Conference on Harmonization (ICH) regulations and human subjects protection requirements.
  3. Works with study investigators to develop recruitment and screening procedures and documentation. Designs and writes recruitment documents.
  4. Produces study documents such as informed consent forms, protocol abstracts, and study management tools.
  5. Maintains study and regulatory documentation.
  6. 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.
  7. Provides education and support to study participants and their families. Communicates with participants throughout the course of the study.
  8. Acts as liaison between principal investigators, regulatory agencies, D-H stakeholders, and study participants to resolve problems.
  9. Travels to investigator meetings and study training.
  10. Performs other duties as required or assigned.

Minimum Qualifications:
  • Bachelor’s degree with 3 years of clinical research experience, or the equivalent in education and experience, required.
  • Excellent organizational, writing, and office software skills required.
  • Certification through the Society of Clinical Research Associates (SOCRA) or Association of Clinical Research Professionals (ACRP) preferred.
Required Licensure/Certification Skills:

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