Senior Phase I CRA – Remote Oversight & Site Excellence

Parexel; Honolulu (HI); Remote; USD 90,000 - 125,000; Full time

Job summary

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. The role involves on-site and remote activities with CTL collaboration to ensure study deliverables meet ICH GCP and regulatory standards.

Responsibilities include site visits, monitoring oversight, data integrity, and timely reporting. Strong analytical skills, communication, and knowledge of FDA/EMA/PMDA regulations are essential.

Qualifications

• Bachelor's degree or equivalent is required.
• Minimum of 5 years of related experience for Senior CRA.
• Strong analytical and critical thinking abilities.
• Working knowledge of the clinical drug development process, ICH GCP guidelines, and regulatory requirements (FDA, EMA, PMDA).

Responsibilities

• Perform site management and monitoring activities in line with protocol, plan, ICH GCP and regulatory requirements.
• Conduct site qualification, initiation, interim, and close-out visits on-site and remotely.
• Partner with CTLs and other client functions to support site activation and deliverables.
• Establish relationships with investigator site staff and ensure effective communication throughout study conduct.
• Perform drug accountability, reconciliation, and destruction per protocol storage/shipment rules.
• Prepare and maintain Oversight Monitoring Plan and review study metrics to assess site performance.
• Review site source documents and verify accurate data capture (ALCOA principles).
• Write and submit monitoring visit reports and oversight reports timely.
• Identify and record protocol deviations, elevate non-compliance, and resolve study-related issues.
• Maintain ongoing communication with study teams, CTLs, Central Monitors, and CRO CRAs.
• Support inspection readiness activities and ensure data integrity and protocol deliverables.

Skills

Effective communication

Interpersonal skills

Analytical problem-solving

Time management

Prioritization

Education

Bachelor's degree (or equivalent)

Tools

CTMS

EDC

Microsoft Office

Data repositories

Job description

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. The role involves on-site and remote activities with CTL collaboration to ensure study deliverables meet ICH GCP and regulatory standards.

Responsibilities include site visits, monitoring oversight, data integrity, and timely reporting. Strong analytical skills, communication, and knowledge of FDA/EMA/PMDA regulations are essential.