CRA Freelance

Walker Cole International is currently partnered with a Biotech searching for an Freelance CRA in Europe for a contract of 6 months initially for 2026.

Key Responsibilities:

Clinical Trial Management

• Monitor clinical trial sites to ensure compliance with study protocols, GCP, and regulatory requirements.
• Conduct site initiation, interim monitoring, and close-out visits.
• Oversee site performance, enrollment, and data quality.
• Verify informed consent procedures and ensure patient safety and confidentiality.

Regulatory and Compliance

• Ensure adherence to ICH-GCP guidelines, local regulations, and company SOPs.
• Review essential documents and maintain Trial Master Files (TMF/eTMF).
• Support regulatory submissions and ethics committee documentation.
• Identify protocol deviations and support corrective and preventive actions (CAPAs).

Data Quality and Reporting

• Perform source data verification (SDV) and source data review (SDR).
• Collaborate with data management teams to resolve queries in a timely manner.
• Prepare monitoring reports and follow-up letters.
• Track study metrics, timelines, and deliverables.

Site and Stakeholder Management

• Build and maintain strong relationships with investigators and site staff.
• Provide training on protocols, systems, and study procedures.
• Collaborate with cross-functional teams, including Clinical Operations, Medical Affairs, Regulatory Affairs, Biostatistics, and Pharmacovigilance.
• Support feasibility assessments and site selection activities.

Required Qualifications:

• Bachelor’s degree in Life Sciences, Nursing, Pharmacy, or a related field.
• Minimum of 2–5 years of experience as a Clinical Research Associate in a biotech, pharmaceutical, or CRO environment.
• Strong knowledge of ICH-GCP, FDA, EMA, and other global regulatory requirements.
• Experience with electronic data capture (EDC) systems and eTMF platforms.
• Proficiency in Microsoft Office Suite.

Contract details:

• Start date: 2026 April
• 2-3 days per week
• 80-100euros per hour (dependent on experience level)
• Duration of project: 6 months (with likely extension)
• Location: Europe - remote 

CRA l Clinical l Clinical Research Associate l Clinical Trials l Contract l Contractor l Biopharma l Biotech