Freelance Senior CRA (Oncology) - Remote

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

Zusammenfassung

A leading biotechnology research company is seeking a Senior Freelance CRA with oncology experience. This role involves managing clinical trial sites, ensuring compliance with regulations, and requires significant freelancing experience. Candidates must be fluent in German and English and willing to conduct multiple on-site visits per month.

Qualifikationen

• Minimum of 2 years' on-site monitoring experience as a CRA.
• Fluent in German and English, both verbal and written.
• Understanding of clinical research, trials, GCP/ICH, and relevant laws.

Aufgaben

• Manage on-site stakeholder relationships throughout trial phases.
• Perform clinical study site management and monitoring, ensuring compliance.
• Handle site selection, readiness procedures, coordination, and collaboration.

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 have partnered with a global biotechnology research company, currently seeking a Senior Freelance CRA with immediate availability and senior oncology indication experience.

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 study site management and monitoring, ensuring compliance with ICH-GCP, sponsor SOPs, site monitoring plans, documents, and local laws/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 start-up, 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 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 of 2 years' on-site monitoring experience as a CRA (CRO/Bio/Pharma).
• Fluent in German and English, both verbal and written.
• Effective communication of technical information.
• Understanding of clinical research, trials, 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 appropriately.

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

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

Desired Skills and Experience:

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