Sr CRA, Early Development — Remote

Parexel; Providence (RI); Hybrid; USD 90.000 - 130.000; Vollzeit

Zusammenfassung

Parexel seeks 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, while collaborating with cross-functional teams to meet study deliverables.

Responsibilities include site visits (on-site and remote), data integrity reviews, and preparing monitoring and oversight reports. Strong communication and documentation skills are essential.

Qualifikationen

• Minimum of 5 years of related experience for Sr 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 (FDA, EMA, PMDA)

Aufgaben

• Perform site management and monitoring activities to ensure protocol and regulatory compliance
• Conduct site qualification, initiation, interim, and close-out visits, on-site and remote
• Collaborate with CTL and client functions to support site activation and deliverables
• Maintain productive relationships with investigator site staff and ensure effective communication
• Perform drug accountability, reconciliation, and destruction per storage and shipment requirements
• Prepare and maintain Oversight Monitoring Plan and review study metrics
• Write and submit monitoring visit reports and oversight reports promptly
• Verify completeness of site documentation and regulatory files
• Identify and record protocol deviations and resolve issues
• Maintain ongoing communication with site personnel, study teams, CTLs, and CRO CRAs
• Support inspection readiness activities and data integrity

Kenntnisse

Communication

Interpersonal skills

Problem solving

Analytical thinking

Time management

Written reporting

Ausbildung

Bachelor's degree

Tools

Microsoft Office

EDC

CTMS

Data repositories

Jobbeschreibung

Parexel seeks 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, while collaborating with cross-functional teams to meet study deliverables.

Responsibilities include site visits (on-site and remote), data integrity reviews, and preparing monitoring and oversight reports. Strong communication and documentation skills are essential.