DUTIES AND RESPONSIBILITIES:

  • Assists in the development of protocols, case report forms, informed consent forms, clinical research forms/documents, and IRB materials.
  • Collects, reviews and maintains regulatory documents and performs IRB submissions.
  • Qualifies, initiates, monitors and closes out clinical sites conducting research in accordance with company SOPs.
    • Maintains close communication with clinical sites to ensure adherence to protocol and regulatory requirements.
    • Performs source document verification, retrieves or audits case report forms (CRFs) and performs query resolution in a timely manner and oversees safety at clinical sites.
    • Monitors informed consent documents.
    • Collects study related support documentation (e.g., IRB approvals and renewals, correspondence, updated licenses & CVs, etc.).
    • Monitors Regulatory Binder.
    • Provides timely reporting and reporting of subject safety, adverse events (AEs), serious adverse events (SAEs) and protocol violations to sponsor and IRB.
    • Completes and submits monitoring reports.
  • Assists in training of investigators and study coordinators in research and study specifics as needed based on new personnel and/or study compliance and corrective action indications.
  • Generates reports for site and project management.
  • Forms partnership with other field-based personnel for effective management and communication with assigned study sites. If required, assists in the preparation of subject narratives and other data requirements.
  • Maintains a thorough understanding of current monitoring practices and applicable regulatory requirements and guidelines.
  • Other duties in support of research or Company, as needed.

 

QUALIFICATIONS:

  • Bachelor's degree in a science or healthcare field preferred
  • ACRP certification preferred
  • A minimum of 4 years of direct CRA experience in site management and logistical execution of clinical trials within device, pharmaceutical, biotechnology, CRO and/or healthcare setting
  • Demonstrates core understanding of medical terminology and clinical trial activities in relation to the execution of a clinical development plan
  • Medical Device experience preferred
  • Good verbal and written communication skills and attention to detail and organizational skills are necessary
  • Basic knowledge of GCP and FDA regulations
  • Ability to multi-task under limited direction and on own initiative computer skills, including proficiency in the use of Microsoft Word, Excel, PowerPoint, and organization tools and experience with electronic data capture systems of patient data, is desirable