Full-Cycle Clinical Research Coordinator

Mountain Area Health Education Center; Biltmore (FL); Sur place; USD 52 000 - 64 000; Plein temps

Résumé du poste

Mountain Area Health Education Center in Asheville, NC, seeks a Clinical Research Coordinator to manage day-to-day activities for human subjects research and clinical trials under the PI and Clinical Research Nurse Manager. The CRC ensures compliant, efficient study conduct in line with GCP, IRB approvals, and MAHEC policies.

Responsibilities cover feasibility through closeout, including recruitment, consent, data and regulatory management, monitoring, and collaboration with sponsors, monitors,

Qualifications

• Bachelor’s degree or equivalent in health sciences or related field.
• At least 1 year of clinical research/ data coordination experience.
• Knowledge of GCP, HIPAA, informed consent processes and IRB procedures.

Responsabilités

• Coordinate study activities from feasibility to closeout with appropriate oversight.
• Develop IRB-approved recruitment and retention strategies; prescreen, schedule, and follow participants.
• Escalate deviations, safety concerns, or regulatory issues to PI or licensed clinician as required.
• Prepare and maintain regulatory files, source documentation, and study records in inspection-ready state.
• Ensure data entry into approved systems and maintain data integrity per ALCOA+ principles.

Connaissances

Clinical research

GCP

HIPAA

Informed consent

Data coordination

IRB submissions

Formation

Bachelor’s degree in health sciences or related field

RN license or clinical credential (preferred)

ACRP or SoCRA certification (preferred)

Outils

Electronic Medical Records

EDC systems

Clinical trial management systems

Sponsor portals

Description du poste

Mountain Area Health Education Center in Asheville, NC, seeks a Clinical Research Coordinator to manage day-to-day activities for human subjects research and clinical trials under the PI and Clinical Research Nurse Manager. The CRC ensures compliant, efficient study conduct in line with GCP, IRB approvals, and MAHEC policies.

Responsibilities cover feasibility through closeout, including recruitment, consent, data and regulatory management, monitoring, and collaboration with sponsors, monitors,