Freelance Senior CRA (Oncology) - Remote

iO Associates - UK / EU; Köln; Remote; EUR 40.000 - 60.000; Vollzeit

Zusammenfassung

A global biotechnology research company is seeking a Senior Freelance Clinical Research Associate (CRA) with oncology experience. The role involves managing site relationships, ensuring compliance with clinical protocols, and conducting oversight activities. Candidates should have a scientific background, fluent in German and English, and possess strong site management skills. This position requires frequent on-site visits across Germany, with travel compensated at an hourly rate.

Qualifikationen

• Minimum 2 years of on-site monitoring experience as a CRA.
• Fluent in German and English, both verbal and written.
• Strong understanding of clinical research and GCP/ICH guidelines.

Aufgaben

• Manage on-site stakeholder relationships throughout trial phases.
• Perform clinical site management and monitoring in compliance with regulations.
• Conduct unbiased oversight activities for site data generation.

Kenntnisse

Stakeholder Management

Site Management

Patient Recruitment

Data Analysis

Effective Communication

Ausbildung

Bachelor's degree in a scientific field

Tools

CTMS

eTMF

MS Office

Jobbeschreibung

iO Associates has partnered with a global biotechnology research company, currently seeking an immediate-availability Senior Freelance CRA with experience in oncology indications.

This is a sponsor-dedicated role, and we are 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 site management and monitoring in compliance with ICH-GCP, sponsor SOPs, site plans, and local regulations.
3. Handle site selection, readiness procedures, coordination, and collaboration.
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 effectively 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 and compliance issues via the CRA Escalation Pathway, collaborating with CRM, PLM, and RCPM.
2. Manage information in CTMS, eTMF, and other systems.
3. Support or lead audit and inspection activities.

Candidate Requirements :

• Bachelor's degree in a scientific field and relevant bio-sector experience.
• Minimum 2 years of on-site monitoring experience as a CRA in CRO, biotech, or pharma settings.
• Fluent in German and English (verbal and written).
• Effective communication of technical information.
• Strong understanding of clinical research, GCP/ICH guidelines, and clinical research laws.
• Knowledge of Good Documentation Practices.
• Proven skills in site management, performance, and patient recruitment.
• Strong IT skills, including clinical applications and MS Office.
• Ability to analyze data and metrics appropriately.

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

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

Desired Skills and Experience

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