Parexel FSP is seeking a motivated Clinical Research Associate (CRA) or Senior Clinical Research Associate (Sr CRA) with oncology experience to join our dynamic team. As a CRA, you will play a key role in managing clinical studies at assigned sites, ensuring that all study commitments are met efficiently and effectively.

Key Responsibilities:
• Assist in selecting potential investigators and participate in study start-up and regulatory maintenance.
• Conduct Site Qualification Visits and ensure all necessary documentation is collected and accurately prepared for submission to ethical committees and regulatory bodies.
• Provide training and support to site staff on study-related matters, including Risk-Based Quality Management (RbQM) principles.
• Interpret and confirm staff training compliance, ensuring sites remain inspection-ready at all times.
• Actively participate in local study team meetings and contribute to National Investigators meetings.
• Monitor and close study sites in accordance with established procedures, while driving site performance and proactively resolving any study-related issues.
• Update clinical trial management systems (CTMS) and manage study supplies and drug accountability at sites.
• Conduct monitoring visits (both remote and onsite) in accordance with the study-specific Monitoring Plan.
• Perform Source Data Review (SDR) and data verification to ensure data integrity.
• Manage communication regarding adverse event reporting and ensure timely follow-ups.
• Ensure compliance with ICH-GCP, study protocols, and local regulations.

Qualifications:
• Bachelor's degree in a life sciences discipline or equivalent qualification required.
• Excellent understanding of ICH-GCP guidelines and local regulations.
• Strong attention to detail and effective communication skills.
• Ability to work collaboratively in a team-oriented environment and manage multiple projects simultaneously.
• Willingness to travel nationally or internationally as necessary.

Parexel is committed to fostering an inclusive environment. We welcome applications regardless of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.