Senior CRA - Phase I Monitoring Expert (Remote)

Parexel; Denver (CO); À distance; USD 85 000 - 120 000; Plein temps

Résumé du poste

Parexel is seeking a Senior CRA to support monitoring and site management for client-sponsored studies. You will conduct visits on-site and remotely, review regulatory documents, and collaborate with cross-functional teams to ensure study deliverables are met on time and in compliance.

The role requires strong analytical, communication, and data-management skills, with experience in ICH GCP and regulatory requirements.

Qualifications

• Bachelor's degree (or equivalent) required.
• Minimum of 5 years of related experience for Sr CRA.
• Knowledge of ICH-GCP guidelines and regulatory requirements (FDA/EMA/PMDA).
• Experience with investigator sites and CRO partnerships.
• Excellent written and verbal communication skills.

Responsabilités

• Perform site management activities to ensure protocol and regulatory compliance.
• Conduct site qualification, initiation, interim, and close-out visits, on-site and remotely.
• Partner with CTL and other client functions to support site activation and deliverables.
• Establish and maintain professional relationships with investigator site staff for effective communication.
• Perform drug accountability, reconciliation, and destruction per protocol.
• Prepare and maintain Oversight Monitoring Plan.
• Review study metrics and identify sites for oversight monitoring visits.
• Conduct Oversight Monitoring Visits at sites, solo or with CRO CRA.
• Review site source documentation and verify ALCOA data capture.
• Prepare reports on status of study conduct and follow up on issues.
• Ensure site regulatory files are current and submissions are timely.
• Write and submit monitoring visit reports and study correspondence.
• Verify completeness of site documentation.
• Identify deviations, escalate non-compliance, and resolve issues.
• Maintain ongoing communication with site personnel and CTLs.

Connaissances

Analytical skills

Communication skills

Time management

Attention to detail

Cross-functional collaboration

Formation

Bachelor's degree or equivalent

Outils

EDC

CTMS

Microsoft Office

Description du poste

Parexel is seeking a Senior CRA to support monitoring and site management for client-sponsored studies. You will conduct visits on-site and remotely, review regulatory documents, and collaborate with cross-functional teams to ensure study deliverables are met on time and in compliance.

The role requires strong analytical, communication, and data-management skills, with experience in ICH GCP and regulatory requirements.