Sr. Clinical Research Associate (US)

Site Monitoring and Management:

• Conduct onsite and remote monitoring visits, including site qualification, initiation, and close-out.
• Review source documents, resolve data queries, and ensure compliance with ICH/GCP and regulations.
• Coordinate shipment of clinical supplies and maintain study files (ISF, TMF).

Site Recruitment and Setup:

• Identify and advise on site investigators; perform site selection and initiation visits.
• Support site activation, patient recruitment, and ensure project milestones are met.
• Collaborate with start-up and regulatory teams to finalize documents and translations.

Mentoring and Internal Initiatives:

• Mentor and assess CRA I and II through co-monitoring visits and feedback.
• Participate in candidate interviews and contribute to best practices and process improvements.
• Represent the team in audits, inspections, and study progress meetings.