Senior Phase I CRA - Remote Monitoring & Site Oversight

Parexel; Jackson (MS); Remote; USD 85,000 - 110,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. Role includes on-site and remote activities, CTMS documentation, and collaboration with cross-functional teams to meet study deliverables.

Responsibilities include site qualification/initiation/visits, data integrity checks, and timely reporting. 5+ years of CRA experience and strong ICH GCP knowledge are required.

Qualifications

• 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 and monitoring activities to ensure protocol, monitoring plan, ICH GCP, and local regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits, both on-site and remotely.
• Prepare and maintain Oversight Monitoring Plan and review study metrics.
• Review site source documentation and verify accurate data capture (ALCOA principles).
• Write and submit monitoring visit reports and study correspondence in a timely manner.

Skills

Effective communication

Interpersonal skills

Analytical problem-solving

Critical thinking

Time management

Documentation/report writing

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

EDC

CTMS

Data repositories

Job description

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. Role includes on-site and remote activities, CTMS documentation, and collaboration with cross-functional teams to meet study deliverables.

Responsibilities include site qualification/initiation/visits, data integrity checks, and timely reporting. 5+ years of CRA experience and strong ICH GCP knowledge are required.