Clinical Research Coordinator: Lead Trial Ops & Compliance

Prolerity Clinical Research, Inc.; Somers Point (NJ); Sur place; USD 55 000 - 75 000; Plein temps

Résumé du poste

Prolerity Clinical Research, Inc. is seeking a Clinical Research Coordinator to oversee daily operations of assigned studies. You will work with investigators, clinical staff, sponsors, and CROs to ensure compliance with protocols and regulatory standards.

The role focuses on study coordination, data management, and sponsor communication from start-up through close-out, with opportunities to mentor fellow coordinators and contribute to QA readiness.

Qualifications

• Bachelor’s degree in a related field is required.
• Minimum of two (2) years of clinical research or clinical trial management experience.
• Medical certification or licensure (e.g., MS, LPN, RN) preferred.

Responsabilités

• Manage daily operational activities of assigned clinical studies from initiation to close-out.
• Coordinate study start-up activities including regulatory submissions and site activation.
• Attend investigator meetings and site initiation visits.
• Oversee recruitment, enrollment, and informed consent discussions.
• Maintain source documentation, CRFs, regulatory files, and study records.
• Monitor subjects, report adverse events, and escalate safety concerns as needed.
• Enter data into EDC and resolve sponsor or monitor queries promptly.
• Support QA activities and ensure compliance with SOPs and GCP.

Connaissances

Leadership

Communication

Organization

Attention to detail

Time management

Confidentiality

Office software

Formation

Bachelor’s degree in a related field

Outils

EDC systems

Description du poste

Prolerity Clinical Research, Inc. is seeking a Clinical Research Coordinator to oversee daily operations of assigned studies. You will work with investigators, clinical staff, sponsors, and CROs to ensure compliance with protocols and regulatory standards.

The role focuses on study coordination, data management, and sponsor communication from start-up through close-out, with opportunities to mentor fellow coordinators and contribute to QA readiness.