About The Position

The Assistant Clinical Research Coordinator provides administrative and technical assistance to research team in all aspects of clinical research operations and ongoing research projects.

Requirements

  • High School diploma
  • Two years related experience required.

Responsibilities

  • Assists clinical research coordinator with preparation of requisite documents to be sent to the Sponsor; under direction of PI may draft various communications with Sponsor.
  • Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities.
  • Assures lab certification and normals are in place to insure compliance of requisite sponsored documents, which may include but not limited to laboratory certification.
  • Prepares space for study equipment and supplies as requested and maintains supply inventory and equipment.
  • Schedules appointments and procedures as per protocol.
  • Supports coordinators in maintaining accurate source documentation and documenting handling of test articles and clinical supplies.
  • Learns to monitor compliance with regulatory standards.
  • Obtains pertinent medical records as requested; reviews patient records and protocol requirements and reports back to Clinical Research Coordinator and/or PI with findings.
  • Assists with patient enrollment and tracks enrollment figures and in assuring all screening, eligibility and procedures are performed.
  • Assists in processing and shipping lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations.
  • Participates in pre-site visit and site initiation with the research team as requested; assists with study initiation.
  • Adheres to internal controls and reporting structure.
  • If appropriately trained and tested for competency, obtains vital signs and performs phlebotomy; maintains temperature and QC logs per protocol compliance.
  • Performs related duties as required.
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