Job Summary
As a Senior Clinical Research Associate (SrCRA), you will play a critical role in supporting monitoring and site management activities for client-sponsored studies. You will ensure adherence to ICH GCP guidelines, local regulations, and client SOPs while interacting with sites both on-site and remotely. Your collaboration with cross-functional clinical study teams and investigator site personnel will be integral to achieving efficient and effective study deliverables.

Key Responsibilities
• Site Management and Monitoring Activities:
• Conduct comprehensive site management activities to ensure compliance with study protocols.
• Perform site qualification, initiation, interim, and close-out visits seamlessly.
• Collaborate with Clinical Trial Liaisons (CTL) and other internal functions to drive site activation.
• Foster strong professional relationships with site staff for effective communication and problem-solving.
• Manage drug accountability, reconciliation, and ensure compliance with storage and shipment protocols.
• Oversight Monitoring:
• Create and maintain an Oversight Monitoring Plan.
• Review study metrics and evaluate site performance, identifying candidates for oversight visits.
• Conduct Oversight Monitoring Visits to ensure data integrity and accuracy.
• Review site source documentation while applying ALCOA principles.
• Documentation and Reporting:
• Maintain current regulatory files and verify timely documentation submissions.
• Draft and submit accurate monitoring visit and oversight reports promptly.
• Regularly verify the completeness of site documentation.
• Issue Management and Escalation:
• Identify and document protocol deviations, escalating non-compliance as needed.
• Track and report issues to relevant teams for quick resolution.
• Collaboration and Communication:
• Keep open lines of communication with site personnel and study teams.
• Engage actively in team meetings to improve study outcomes.
• Inspection Readiness:
• Support inspection readiness activities to guarantee data integrity and compliance.

Job Requirements
• Education: Bachelor’s degree or equivalent.
• Experience: Minimum of 5 years relevant experience in clinical research.
• Skills:
• Strong analytical and problem-solving skills.
• In-depth knowledge of clinical drug development and regulatory requirements.
• Effective communication and interpersonal skills.
• Proficiency in IT applications including Microsoft Office, EDC, CTMS, and data repositories.
• Ability to produce clear and concise reports.
• Excellent prioritization and time management skills.

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status.