Senior CRA - Phase I Site Monitoring & Oversight

Parexel; Lansing (MI); Sur place; USD 90 000 - 130 000; Plein temps

Résumé du poste

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. You will ensure adherence to ICH GCP, local regulations, and SOPs, with interactions at sites both on-site and remotely, and with CRO partners for oversight.

You will collaborate with cross-functional teams to meet study deliverables, review data and metrics, and help ensure data integrity and timely reporting.

Qualifications

• Bachelor's degree (or equivalent) is required.
• Minimum of 5 years of related experience for Sr CRA role.
• Familiarity with ICH GCP guidelines and regulatory requirements.

Responsabilités

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

Connaissances

Communication skills

Analytical thinking

Time management

Written reporting

Prioritization

Formation

Bachelor's degree

Outils

CTMS

EDC

Microsoft Office

Data repositories

Description du poste

Parexel is seeking a Senior Clinical Research Associate (SrCRA) to support monitoring and site management for client-sponsored studies. You will ensure adherence to ICH GCP, local regulations, and SOPs, with interactions at sites both on-site and remotely, and with CRO partners for oversight.

You will collaborate with cross-functional teams to meet study deliverables, review data and metrics, and help ensure data integrity and timely reporting.