Clinical Research Associate — Impactful Trial Monitoring

allied executive solutions; New Jersey; Hybrid; USD 65,000 - 90,000; Full time

Job summary

Allied Executive Solutions is seeking a Clinical Research Associate (CRA) to monitor trial sites to ensure adherence to protocol, GCP, and regulatory requirements. You will act as the primary liaison between sponsor/CRO and sites, safeguarding data integrity and patient safety throughout the study lifecycle.

Responsibilities include site selection, initiation, monitoring visits, SDV/SDR, data reconciliation, TMF maintenance, and aiding site staff training.

Qualifications

• Bachelor's degree in life sciences, nursing, pharmacy, or related field.
• 1–3+ years of CRA or clinical trial monitoring experience.
• Working knowledge of ICH-GCP guidelines and regulatory requirements.
• Familiarity with SDV/SDR and query management.
• Experience with EDC systems and CTMS.

Responsibilities

• Conduct site selection, initiation, routine monitoring, and close-out visits per monitoring plan.
• Verify informed consent procedures and protect patient rights and safety.
• Perform SDV/SDR to ensure accuracy of CRFs.
• Review data against source documents and resolve discrepancies with site staff.
• Monitor investigational product accountability, storage, and dispensing.
• Maintain Trial Master File (TMF) and site regulatory files for inspections.

Education

Bachelor's degree in life sciences, nursing, pharmacy, or related field

Tools

EDC (Electronic Data Capture)

CTMS

Job description

Allied Executive Solutions is seeking a Clinical Research Associate (CRA) to monitor trial sites to ensure adherence to protocol, GCP, and regulatory requirements. You will act as the primary liaison between sponsor/CRO and sites, safeguarding data integrity and patient safety throughout the study lifecycle.

Responsibilities include site selection, initiation, monitoring visits, SDV/SDR, data reconciliation, TMF maintenance, and aiding site staff training.