Freelance Senior CRA (Oncology) - Remote

iO Associates have partnered with a Global Biotechnology Research company, who're currently seeking a Senior Freelance CRA with immediate availability and senior Oncology indication experience.

This is a sponsor-dedicated role, and we're interested in speaking to CRAs with significant freelancing experience and strong references.

Role Responsibilities :

1. Manage on-site stakeholder relationships throughout trial phases.
2. Perform clinical study site management and monitoring, ensuring compliance with ICH-GCP, Sponsor SOPs, site monitoring plans, local laws, and regulations.
3. Oversee site selection, site readiness, and coordination.
4. Develop a detailed understanding of the study protocol and procedures.
5. Conduct unbiased oversight activities for site data generation, ensuring subject rights and protection.
6. Review regulatory documents for study startup, maintenance, and close-out.
7. Communicate with investigators and site staff regarding protocol and conduct issues.
8. Record data from site visits, including validation, initiation, monitoring, and close-outs.

Additional Responsibilities :

1. Escalate site performance or compliance issues via the CRA Escalation Pathway, collaborating with CRM, PLM, and RCPM.
2. Manage information and documents in CTMS, eTMF, and other systems.
3. Support and lead audit and inspection activities.

Candidate Requirements :

• BSc or BA in a scientific field with relevant bio-sector experience.
• Minimum 2 years of on-site monitoring experience as a CRA in CRO, Bio, or Pharma sectors.
• Fluent in German and English, both verbal and written.
• Effective communication of technical information.
• Good understanding of clinical research, GCP/ICH, and relevant laws and guidelines.
• Knowledge of Good Documentation Practices.
• Proven site management, performance, and patient recruitment skills.
• Strong IT skills, including clinical applications and MS Office.
• Ability to analyze data and metrics effectively.

Willing to perform 5-6 on-site monitoring visits per month in Germany. Travel time will be paid according to your hourly rate.

Please apply today or contact Adam Akhtar at iO Associates for more information.

Desired Skills and Experience

ICH-GCP, SOPs, Compliance, Stakeholder Management, CIMS, eTMF, CRA, Oncology, Freelance