Onsite CRC II: Metabolic Trials & Team Collaboration

Headlands Research, Inc.; Escondido (CA); Sur place; USD 73 000 - 80 000; Plein temps

Résumé du poste

Headlands Research AMCR Institute in Escondido, CA is seeking an experienced Clinical Research Coordinator to join our onsite team. You will oversee study activities, ensure protocol adherence, and deliver high-quality participant care across metabolic and immunologic trials.

This full-time role emphasizes collaboration, data integrity, and regulatory compliance, with SOPs, GCP, and FDA guidelines guiding everyday work.

Qualifications

• Experience managing multiple phase 2-4 industry-sponsored trials as primary coordinator.
• Education in health-related field or equivalent clinical research training.
• Strong knowledge of FDA regulations and ICH-GCP.
• Experience with EDC, IVRS, and clinical research platforms.
• Proficient medical terminology and clinical documentation.
• Excellent organizational and multitasking abilities.
• Clear, professional verbal and written communication.
• Willingness to work onsite in a collaborative environment.

Responsabilités

• Provide high-quality care for study patients.
• Coordinate all aspects of assigned clinical trials from initiation to close-out.
• Ensure accurate, timely documentation per protocol.
• Maintain compliance with FDA regulations, GCP guidelines, IRB, and SOPs.
• Manage recruitment, informed consent, and retention.
• Support data entry and resolve queries in EDC.
• Collaborate with investigators, sponsors/CROs, labs, and teams.
• Assist in monitoring visits, audits, and inspections.
• Maintain regulatory documentation and training compliance.

Connaissances

Clinical trial coordination

FDA & ICH-GCP knowledge

Communication skills

Organizational skills

Onsite work capability

Education in health field

EDC/IVRS experience

Clinical documentation

Formation

Bachelor's degree

Health-related coursework/experience

Outils

EDC systems

IVRS

Description du poste

Headlands Research AMCR Institute in Escondido, CA is seeking an experienced Clinical Research Coordinator to join our onsite team. You will oversee study activities, ensure protocol adherence, and deliver high-quality participant care across metabolic and immunologic trials.

This full-time role emphasizes collaboration, data integrity, and regulatory compliance, with SOPs, GCP, and FDA guidelines guiding everyday work.