Sr. Clinical Research Associate (Poland)

Responsibilities:

• Manage, deliver, or perform full clinical site monitoring services for complex multinational projects, including training, patient recruitment, data/document management, and budget oversight.
• Serve as Lead CRA, acting as primary liaison between CRAs and project team, and participate in developing project plans, protocols, CRFs, and other monitoring tools.
• Represent the corporation by maintaining collaborative relationships with stakeholders.

Monitoring - Subject Expert:

• Act as subject matter expert, mentor, and coach, providing performance feedback to manager for peers.
• Assist with selection, hiring, training, and supervision of CRAs as needed.
• Perform co-monitoring and training visits and act as first escalation point for site/patient issues.

Project Monitoring Lead:

• May be assigned Lead CRA role, managing monitoring services for large/complex projects including directing day-to-day activities and approving monitoring reports.
• Function as liaison between CRAs and other functional teams, escalating concerns to management.
• Participate in study team, kickoff, and investigator meetings as primary sponsor contact for monitoring issues.

Site Recruitment and Setup:

• Identify and recruit site investigators, coordinate trial materials, samples, tests, and forms including investigational product and protocols.
• Ensure SOPs optimize patient recruitment and provide guidance on inclusion/exclusion criteria.
• Oversee overall study integrity and facilitate site access to study systems and compliance with training requirements.