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 who can bring 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 :

• You'll be responsible for on-site stakeholder management, maintaining excellent relationships throughout trial phases
• Perform clinical study site management and monitoring (compliance with ICH-GCP, Sponsor SOPs, site monitoring plans and docs, local laws / regulations etc
• Site selection and site-ready procedures, coordination and collaboration.
• Develop detailed understanding of the study protocol / procedures
• Perform accurate, unbiased oversight (monitoring) activities for site data generation, subject's right & protection
• Review regulatory docs for study start up, maintenance and close-out.
• Communicate with investigators and site staff on any protocol / conduct related issues
• Conduct and record data from occasional site visits (validation, initiation, monitoring, close-outs)

Additional Responsibilities :

• Escalate site performance / compliance issues via the CRA Escalation Pathway as appropriate, in collaboration with CRM, PLM and RCPM
• Manage information and coumen ts in CTMS, eTMF and other systems
• Support / lead on audit and inspection activities

Candidate Requirements :

• BA / BS in Scientific area of study and relevant work experience gained in the Bio-sector
• At least 2yrs experience with direct on-site monitoring as a CRA (for CRO / Bio / Pharma)
• Must be fluent in German and English (verbal and written)
• Able to communicate technical information effectively
• Good understanding of clinical research, clinical trials, GCP / ICH and clinical research law and guidelines + an understanding of Global & Country Clinical Research Guidelines
• Working knowledge of Good Documentation Practices
• Proven skills in site management, performance and patient recruitment
• Strong IT skills (clinical IT applications and MS Office)
• Able to understand and analyse data / metrics appropriately

You must be willing to perform 5-6 on-site monitoring visits per month in Germany

Travel time will be paid in accordance with your hourly rate!

Please Apply today or reach out to Adam Akhtar at iO Associates - EU, for further information!

Desired Skills and Experience

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