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CO33 – Clinical Research Coordinator

Clinical Research Coordinator

Job Summary:

The Clinical Research Coordinator, (CRC) is to screen, enroll and follow study subjects while ensuring protocol and regulatory compliance and close monitoring while subjects are in study.

Duties Include:

  • Maintain adherence to FDA regulations and ICH guidelines in all aspects of conducting clinical trials
  • Obtain informed consent
  • Complete visit procedures and ensure proper specimen collection processing and shipment in accordance with protocol
  • Be prepared to complete basic clinical procedures, such as blood draws, vital signs, and ECGs
  • Review laboratory results, ECGs, and other test results (e.g., MRI and Biopsy reports) for completeness and alert values, ensure investigator review in a timely fashion
  • Recognize Adverse Events (AEs) and Serious Adverse Events (SAEs) and promptly notify Principal Investigator
  • Schedule patients within visit windows
  • Dispense study medication per protocol and or IVRS system; educate subject on proper administration and importance of compliance
  • Monitor subject progress on study medication

Documentation:

  • Create source documentation
  • Record data legibly, in real time on source documents
  • Accurately record study medication inventory, medication dispensation, and patient compliance
  • Accurately transcribe data to CRFs. Resolve data management queries and correct source data as needed
  • Record protocol exemptions and deviations as appropriate with sponsor
  • Maintain copies of patient-specific correspondence in source charts
  • Assist regulatory personnel with completion of continuing/final review reports

Email To:

deb.applebee@fdhs.com, michele.patterson@fdhs.com

Knowledge, Skills, and Abilities:

  • Excellent working knowledge of medical and research terminology
  • Extensive working knowledge of federal regulations, Good Clinical Practices (GCP)
  • Ability to communicate and work effectively with a diverse team of professionals
  • Strong computer skills with demonstrated abilities using clinical trials database, electronic data capture, MS Word and Excel
  • Excellent interpersonal skills, detailed-oriented and meticulous
  • Ability to work independently in a fast-paced environment with minimal supervision

Experience:

  • Four years of Clinical Research Coordinator experience

License/Certification:

  • GCP
  • Research Professional Certificate - CCRC or exam eligibility preferred