Senior Clinical Research Associate I

About the role

As a Senior Clinical Research Associate I, you will lead site management, monitoring, and close‑out activities for assigned clinical trials, ensuring patient safety and data quality while mentoring junior CRAs.

Key responsibilities

• Independently manage and monitor investigator sites from initiation through database lock, adhering to monitoring plans, SOPs, GCP and regulatory requirements.
• Partner with Site Care Partners on feasibility, site selection, pre‑trial assessments, consent documentation, and site initiation visits.
• Mentor and train assigned Clinical Research Associates, supporting their professional development.
• Serve as a Subject Matter Expert for CRA processes and contribute to regional improvement initiatives.
• Identify, resolve, and document complex site issues, implement CAPAs, and support sponsor regulatory inspections.
• Collaborate with cross‑functional teams—including clinicians, recruitment specialists, and data scientists—to address enrollment challenges and protocol inquiries.
• Oversee site‑level adverse event reporting, investigational product accountability, and co‑monitoring activities as needed.

Required profile

• Bachelor’s degree in Life Sciences or a professional health degree (nursing, pharmacy, medical).
• Minimum 3 years of clinical research site monitoring experience, preferably with oncology exposure.
• Strong knowledge of ICH/GCP, FDA and local regulations.
• Prior experience in global clinical trials is advantageous.

Required skills

• Clinical trial monitoring
• GCP compliance
• ICH guideline application