Senior CRA, Phase I – Remote Monitoring & Oversight

Parexel; Augusta (ME); Remote; USD 90,000 - 130,000; Full time

Job summary

Parexel is seeking a SrCRA to support monitoring and site management for client studies in the United States. You will ensure adherence to ICH GCP, regulatory requirements, and client SOPs, with interactions conducted on-site and remotely and documented in CTMS.

You will partner with CTLs and other client functions to activate sites, monitor study metrics, and oversee data integrity and regulatory filings, ensuring timely reports and issue resolution.

Qualifications

• Bachelor's degree or equivalent required.
• Minimum 5 years of related experience for Sr CRA.
• Strong knowledge of ICH GCP and regulatory requirements (FDA/EMA/PMDA).

Responsibilities

• Perform site management to ensure protocol and regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits on-site and remotely.
• Collaborate with CTL and other client functions to support site activation and deliverables.
• Establish and maintain relationships with investigator site staff for effective communication.
• Oversee drug accountability, reconciliation and destruction per protocol.

Skills

Communication skills

Analytical problem-solving

Regulatory knowledge

Written reporting

Time management

Education

Bachelor's degree or equivalent

Tools

CTMS

EDC

Microsoft Office

Data repositories

Job description

Parexel is seeking a SrCRA to support monitoring and site management for client studies in the United States. You will ensure adherence to ICH GCP, regulatory requirements, and client SOPs, with interactions conducted on-site and remotely and documented in CTMS.

You will partner with CTLs and other client functions to activate sites, monitor study metrics, and oversee data integrity and regulatory filings, ensuring timely reports and issue resolution.