About The Position
The Assistant Clinical Research Coordinator provides administrative and technical assistance to the research team across clinical research operations and ongoing research projects. The role supports study documentation, regulatory compliance, participant enrollment and tracking, specimen processing, equipment and supply management, and study initiation. The position is based in standard hospital, clinical, laboratory, and/or office environments.
Requirements
- High school diploma.
- Two years of related experience.
Responsibilities
- Assist the Clinical Research Coordinator in preparing required documents for submission to the Sponsor and, under the direction of the Principal Investigator, draft communications with the Sponsor.
- Contribute to Good Clinical Practice (GCP) and other regulatory activities.
- Ensure required laboratory certifications and normal ranges are in place for sponsored documentation and compliance.
- Prepare space for study equipment and supplies, and maintain supply inventory and equipment.
- Schedule appointments and procedures according to the study protocol.
- Support coordinators in maintaining accurate source documentation and recording the handling of test articles and clinical supplies.
- Learn to monitor compliance with regulatory standards.
- Obtain requested medical records, review patient records and protocol requirements, and report findings to the Clinical Research Coordinator and/or Principal Investigator.
- Assist with patient enrollment, track enrollment figures, and help ensure screening, eligibility checks, and procedures are completed.
- Assist with processing and shipping laboratory specimens, and retrieve and/or send identified research specimens with certification when required by regulations.
- Participate in pre-site visits and site initiation with the research team as requested, and assist with study initiation.
- Adhere to internal controls and the reporting structure.
- When appropriately trained and competency-tested, obtain vital signs, perform phlebotomy, and maintain temperature and quality-control logs according to protocol requirements.
- Perform related duties as required.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
