Senior Clinical Research Associate (German Contractor)

Theradex Systems, Inc.; Deutschland; Vor Ort; EUR 40.000 - 60.000; Teilzeit

Zusammenfassung

A leading clinical research organization seeks a Freelance SCRA (German Speaker) in Germany for a 0.4-0.5 FTE position on a 3-month contract. Responsibilities include managing clinical trial sites, preparing project materials, and ensuring regulatory compliance. The ideal candidate has a Bachelor's in a related field and at least 5 years of experience as a Clinical Research Associate with thorough knowledge of ICH GCP.

Qualifikationen

• Minimum 5 years as a Clinical Research Associate.
• Strong track record in managing clinical trial sites.
• Experience monitoring early-phase oncology studies.

Aufgaben

• Assist in preparing project-specific materials.
• Maintain effective communication with study sites.
• Ensure patient safety and data integrity.

Kenntnisse

Knowledge of ICH GCP

Effective multitasking

Excellent interpersonal skills

Proficiency in Microsoft Office Suite

Fluent in German

Fluent in English

Ausbildung

Bachelor's degree (BSc, BA, or RN) in biological or related fields

Jobbeschreibung

Who We Are

Celebrating 40+ Years!

Theradex Oncology is a full-service CRO, conducting early and late-phase oncology trials in the U.S, Europe, and Asia. Founded in 1982, we have maintained a strong partnership with the National Cancer Institute (NCI) and have designed and managed over 250 oncology trials. Our mission is to advance cancer treatment and improve patient outcomes.

What You'll Do

We are hiring a Freelance SCRA (German Speaker) based in Germany for a 0.4-0.5 FTE monthly, on a 3-month contract.

The main responsibilities include:

• Assist in preparing project-specific materials such as reports, newsletters, templates, and study manuals.
• Stay informed on literature related to cancer therapy, clinical trial design, and GCP.
• Collaborate with the project team to meet regulatory and study objectives, including contract and budget negotiations.
• Maintain effective communication with study sites, providing updates and support.
• Coordinate with the internal project team regarding site issues.
• Assist in preparing essential documents for site initiation.
• Maintain up-to-date site information and regulatory documentation.
• Perform quarterly quality control of studies/sites in the eTMF system.
• Manage study tracking systems to ensure documentation accuracy and completeness.
• Ensure patient safety, data integrity, and compliance with GCP and regulatory standards.
• Participate in study visits and monitor activities as per SOPs.
• Identify and resolve site and study issues proactively.
• Escalate data quality issues to ensure integrity.
• Support project management with reports and updates.
• Potentially manage multiple studies simultaneously.

What You Need

Education:

• Bachelor's degree (BSc, BA, or RN) in biological or related fields, or equivalent experience.

Experience:

• Minimum 5 years as a Clinical Research Associate, with a strong track record in managing clinical trial sites.
• Experience monitoring early-phase oncology studies.

Skills and Competencies:

• Thorough knowledge of ICH GCP and regulatory requirements.
• Effective multitasking and organizational skills.
• Excellent interpersonal, communication, and presentation skills.
• Ability to develop solutions to study conduct problems.
• Knowledge of drug development processes and organizational structure.
• Proficiency in Microsoft Office Suite.
• Fluent in German and English.

What We Offer:

Theradex is an equal opportunity employer. We encourage all qualified applicants to apply.