Clinical Research Coordinator: Study Operations & Compliance

UTMB Health; Galveston (TX); On-site; USD 52,000 - 76,000; Full time

Job summary

UTMB Health is seeking a Clinical Research Coordinator to obtain human subject data for clinical studies and to handle essential administrative duties that support the protocol. This role emphasizes GCP activities, source documentation, and regulatory compliance within a hospital, clinical, and laboratory setting.

The coordinator schedules visits, monitors enrollment, mentors junior staff, and collaborates with the PI and study monitor.

Qualifications

• Bachelor’s degree or equivalent, and two years of directly related experience.

Responsibilities

• Applies knowledge in contributing to Good Clinical Practice (GCP) activities and/or other regulatory activities.
• Schedules, coordinates, and participates in the pre-site visit and site initiation visits; coordinates study initiation.
• Maintains and monitors source documentation and appropriate forms as per protocol for quality and accuracy, including participant records; assists with the quality assurance process.
• Incorporates directions from other health care disciplines into clinical research protocols when reviewing patient eligibility; assists in eliciting relevant data from sources outside of the hospital.
• Reconciles study drug accountability; maintains temperature and QC logs per protocol compliance.
• Develops and maintains productive working relationship with the study monitor; attends and participates in campus coordinator workshops.
• Identifies and recruits clinical research subjects for participation of studies, collects data, and monitors enrollment goals.
• Mentors new clinical research coordinators and assistant clinical research coordinators.
• Assists with grant/protocol preparation and submission to IRB, OCR or OSP under direction of research coordinator under the direction of the PI and with answering IRB stipulations to obtain final approval; documents IRB approval and contract approval
• Under direction of PI may draft various communications with Sponsor and/or regulatory documents to be sent to the Sponsor.
• May assist PI and/or research nurse coordinator in the planning and design of source documents for protocol.
• Assists in developing procedures for laboratory collection and storage.
• Assists in processing and shipping lab specimens; retrieves and/or sends identified research specimens certified if indicated as per regulations.
• Assists in precepting new clinical research staff and educating other research staff regarding scientific aspects of studies.
• Assists in processing and shipping lab specimens efficiently and cost effectively; maintains supply inventory and equipment; maintains regulatory standards.
• Assists with the budget development; may monitor ledgers.
• Adheres to internal controls established for department.
• May assist PI in obtaining Informed Consent from study participant and documents appropriately.
• Adheres to internal controls and reporting structure.

Skills

GCP knowledge

Clinical research

Regulatory compliance

Data collection

Education

Bachelor's degree or equivalent

Job description

UTMB Health is seeking a Clinical Research Coordinator to obtain human subject data for clinical studies and to handle essential administrative duties that support the protocol. This role emphasizes GCP activities, source documentation, and regulatory compliance within a hospital, clinical, and laboratory setting.

The coordinator schedules visits, monitors enrollment, mentors junior staff, and collaborates with the PI and study monitor.