Senior CRA — Phase I Monitoring & Site Oversight

Parexel; Atlanta (GA); Hybrid; USD 100,000 - 140,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate to support monitoring and site management for sponsored studies. The role combines on-site and remote activities, with oversight of data integrity and regulatory compliance across sites using CTMS and EDC systems.

Responsibilities include site qualification, initiation, interim and close-out visits, documentation, and collaboration with CTL and study teams to meet deliverables while ensuring patient safety and data quality.

Qualifications

• Bachelor’s degree required.
• Minimum of 5 years of related experience for Snr CRA.
• Strong analytical problem-solving skills and critical thinking abilities.
• Working knowledge of the clinical drug development process, ICH GCP guidelines, and applicable regulatory requirements (e.g., FDA, EMA, PMDA).

Responsibilities

• Perform site management activities to ensure compliance with the protocol, monitoring plan, ICH GCP, local regulatory requirements, and client SOPs.
• Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
• Partner with CTL and other client functions to support site activation and deliverables.
• Establish and maintain productive professional relationships with investigator site staff, ensuring effective communication and problem-solving throughout study conduct.
• Perform drug accountability, reconciliation, and destruction, ensuring protocol compliance for storage and shipment requirements.

Skills

Communication skills

Interpersonal skills

Time management

Written reporting

Medical terminology

IT proficiency

Education

Bachelor's degree

Tools

EDC

CTMS

Data repositories

Microsoft Office

Job description

Parexel is seeking a Senior Clinical Research Associate to support monitoring and site management for sponsored studies. The role combines on-site and remote activities, with oversight of data integrity and regulatory compliance across sites using CTMS and EDC systems.

Responsibilities include site qualification, initiation, interim and close-out visits, documentation, and collaboration with CTL and study teams to meet deliverables while ensuring patient safety and data quality.