FREELANCE: Senior CRA - Oncology

Location: Germany, Fully-Remote
Duration: 12-months
Rate: Up to 95 EUR p/h
Start Date: ASAP

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!