Clinical Research Coordinator - Little Rock, AR

QuintilesParsippany-Troy Hills, NJ
309d

About The Position

The Clinical Research Coordinator will perform a variety of complex clinical procedures on subjects including but not limited to ECG, sample collection including phlebotomy, spirometry, and vital signs. The role involves coordinating clinical research studies conducted by a supervising principal investigator and updating and maintaining skills, training, and knowledge of current best nursing practices and topics related to clinical research. The coordinator will safeguard the well-being of the subjects and ensure and maintain high standards, including maintaining a safe environment in accordance with Health and Safety policies. The position also requires acting as a volunteer advocate, addressing volunteer and visitor concerns proactively, and assisting staff in clinical coordinator practices and the delivery of care to the volunteer. The coordinator will report any deviation from normal practice to senior staff and support study conduct by reviewing study protocols, participating in project meetings, and performing clinical set-up and preparation for studies.

Requirements

  • High School Diploma and 1 year of relevant work experience in clinical research.
  • At least 1 year experience working in a clinical research setting preferred.
  • Applicable certifications and licenses as required by company, country, state, and/or other regulatory bodies.
  • Working knowledge of clinical trials and Good Clinical Practices (GCP).
  • In-depth knowledge of protocol and study-specific operating procedures.
  • Skill in carrying out required clinical procedures.
  • Working knowledge of medical terminology.
  • Ability to pay close attention to detail.
  • Ability to establish and maintain effective working relationships.

Responsibilities

  • Perform complex clinical procedures on subjects including ECG, sample collection, spirometry, and vital signs.
  • Coordinate clinical research studies conducted by a supervising principal investigator.
  • Update and maintain skills, training, and knowledge of current best nursing practices.
  • Safeguard the well-being of subjects and maintain high standards.
  • Maintain a safe environment in accordance with Health and Safety policies.
  • Act as a volunteer advocate and address concerns proactively.
  • Assist staff in clinical coordinator practices and delivery of care.
  • Report deviations from normal practice to senior staff.
  • Review study protocols, case report forms, and other study documents.
  • Participate in project meetings with the project team.
  • Perform clinical set-up and preparation for studies.
  • Plan logistical activity for procedures as per protocol.
  • Generate volunteer instructions and obtain required supplies.
  • Prepare and deliver study-specific training materials.
  • Troubleshoot study issues and participate in daily huddles.
  • Assist with data quality checking and query resolution.
  • Recruit and screen volunteers for study inclusion.
  • Orient volunteers to the study and site procedures.
  • Administer and maintain custody of study drug according to SOPs.
  • Collect, record, and report clinical data in case report forms.
  • Collaborate with the study investigator on adverse events.
  • Cooperate with the study monitor during monitoring.
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