Freelance Senior CRA (Oncology) - Remote

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

Zusammenfassung

A leading Global Biotechnology Research company is seeking a Senior Freelance CRA with oncology experience for on-site monitoring in Germany. Ideal candidates will have a background in the bio-sector, fluency in German and English, and a strong understanding of clinical guidelines. Responsibilities include site management, compliance monitoring, and stakeholder communication, with an expectation of 5-6 site visits monthly.

Leistungen

Travel time paid in accordance with hourly rate

Qualifikationen

• At least 2 years experience with on-site monitoring as a CRA in CRO/Bio/Pharma.
• Experience in managing performance and patient recruitment.
• Understanding of GCP/ICH and clinical research guidelines.

Aufgaben

• On-site stakeholder management, maintaining relationships through trial phases.
• Perform clinical study site management and compliance monitoring.
• Conduct site visits and record data for validation and monitoring.

Kenntnisse

Fluent in German

Fluent in English

Site management skills

Understanding of clinical research

Good Documentation Practices

Strong IT skills

Communication of technical information

Data analysis skills

Ausbildung

BA / BS in Scientific area of study

Tools

CIMS

eTMF

MS Office

Jobbeschreibung

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