Assistant Clinical Research Coordinator, Sealy Institute for Vaccine Sciences Operations Research (Galveston)
About The Position
The Assistant Clinical Research Coordinator provides administrative and technical assistance to the research team in all aspects of clinical research operations and ongoing research projects. The position works under the direction of the clinical research coordinator and, as appropriate, the principal investigator (PI), supporting study documentation, regulatory activities, participant enrollment, scheduling, research supplies, and specimen processing. The role is based in standard hospital, clinical, laboratory, and/or office environments and uses standard office equipment. If appropriately trained and tested for competency, the employee may obtain vital signs, perform phlebotomy, and maintain temperature and quality-control logs in accordance with protocol requirements. The position also performs related duties as required.
Requirements
- High school diploma.
- Two years of related experience.
- For vital-sign collection and phlebotomy duties, appropriate training and competency testing are required.
Responsibilities
- Assist the clinical research coordinator with preparing documents to send to the Sponsor and, under PI direction, draft communications with the Sponsor.
- Contribute to Good Clinical Practice (GCP) and other regulatory activities.
- Ensure laboratory certification and normal values are in place to support compliance with sponsored-document requirements.
- Prepare space for study equipment and supplies and maintain supply inventory and equipment.
- Schedule appointments and procedures according to protocol.
- Support coordinators in maintaining accurate source documentation and documenting the handling of test articles and clinical supplies.
- Learn to monitor compliance with regulatory standards.
- Obtain pertinent medical records as requested; review patient records and protocol requirements and report findings to the Clinical Research Coordinator and/or PI.
- Assist with patient enrollment, track enrollment figures, and help ensure screening, eligibility, and procedures are completed.
- Assist with processing and shipping laboratory specimens and retrieve or send identified research specimens with certification when indicated 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.
- If appropriately trained and competency-tested, obtain vital signs, perform phlebotomy, and maintain protocol-compliant temperature and QC logs.
- 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
