CRA II - Oncology/Neurology - Germany - Remote

Worldwide Clinical Trials; United States; À distance; USD 79 000 - 112 000; Plein temps

Résumé du poste

Worldwide Clinical Trials is seeking a CRA II for a home-based position supporting sites in Germany. You will monitor trials, ensure data integrity, and maintain regulatory compliance across study life-cycle from activation to close-out.

Expect collaboration with study teams, sponsors, and investigative sites, with approximately 6–8 site visits monthly. Fluency in German and strong English are required.

Qualifications

• MD/DO/PharmD or life sciences degree with clinical research experience.
• Minimum CRA II level experience in clinical research and monitoring.
• Thorough understanding of GCP, ICH, FDA/EU regulations, and local rules.

Responsabilités

• Conduct site qualification, initiation, monitoring, and close-out visits per protocol and regs.
• Evaluate site feasibility and support site selection for studies.
• Review source documentation and data to ensure accuracy, safety, protocol adherence, and data integrity.
• Prepare and verify regulatory and ethics documentation for study conduct.
• Train and support site personnel on protocol requirements and GCP.

Connaissances

CRA II experience

Site monitoring

GCP knowledge

English proficiency

Formation

Life sciences degree

Outils

MS Office

EDC systems

IxRS

Description du poste

Who we are

We’re a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world’s most persistent diseases is not paved by those who play it safe. It is built by those who take pioneering, creative approaches and implement them with quality and excellence.

We are Worldwide Clinical Trials, and we are a global team of over 3,500+ experts, bright thinkers, dreamers and doers and, together, we are changing the way the world experiences CROs – in the best possible way.

Our mission is to work with passion and purpose every day to improve lives and we are looking for others who value this same pursuit.

Why Worldwide

We believe everyone plays an important role in making a world of difference for patients and their caregivers. From our hands-on, accessible leaders, to our cohesive and supportive teams, we are committed to enabling professionals from all backgrounds and experiences to succeed. We prioritize cultivating a diverse and inclusive environment that continues to promote collaboration and creativity. We are proud to be a workplace where people thrive by being themselves and are inspired to do their best work every day.Join us!

Make an Impact as a CRA II at Worldwide

As a CRA II, you’ll play a critical role in ensuring the quality, integrity, and success of clinical research studies. Your work will directly support patient safety and high-quality data collection, helping advance important research from site activation through study close-out.

In this role, you’ll partner closely with investigative sites, study teams, and stakeholders to drive protocol compliance, maintain regulatory standards, and support efficient study execution. Your expertise in site management and monitoring will help ensure studies are conducted in accordance with GCP, applicable regulations, and established procedures.

You’ll have the opportunity to build strong site relationships, provide guidance and training, and contribute to the successful delivery of clinical trials through proactive problem-solving, collaboration, and attention to detail.

Where You’ll Work

This is a home-based Clinical Research Associate role supporting sites across Germany. Candidates must reside within the territory to effectively support site visits and study activities. You will collaborate with sites, sponsors, and global study teams while traveling to investigative sites approximately 6-8 days per month.

To best support our sites, we’re seeking candidates who are based in Germany.

What You’ll Do

• Conduct site qualification, initiation, monitoring, and close-out visits in compliance with study protocols and regulatory requirements.
• Evaluate site feasibility and support site selection activities for new and ongoing studies.
• Review source documentation and study data to ensure accuracy, patient safety, protocol compliance, and data integrity.
• Prepare, maintain, and verify regulatory and ethics documentation required for study conduct.
• Train and support site personnel on protocol requirements, study processes, and GCP standards.
• Partner with investigative sites to resolve data queries, maintain study documentation, and support audit readiness.
• Monitor investigational product accountability, including receipt, storage, return, or destruction activities.
• Document site visit findings and provide timely updates and essential documentation for Trial Master File maintenance.
• Collaborate with study teams and support the development of monitoring-related study materials and processes as requested.

What You’ll Bring

• Medical Doctor (MD) degree, Pharmacy degree, or equivalent life science qualification with the required clinical research experience; or a four-year degree in a medical, biological, physical, health, pharmacy, or related scientific discipline with clinical research experience.
• Minimum experience requirements consistent with a CRA II level role, including prior experience in clinical research and site monitoring activities.
• Thorough understanding of clinical research processes, GCP, ICH guidelines, FDA and/or EU regulations, and local regulatory requirements.
• Experience managing investigative sites through study start-up, monitoring, and close-out activities.
• Knowledge of multiple therapeutic areas and the ability to independently support clinical trial execution.
• Proficiency with Microsoft Office, electronic data capture (EDC) systems, and IxRS platforms.
• Experience in full-service monitoring PREFERRED.
• Fluent in German and proficient in spoken and written English; valid passport, driving license, and willingness to travel required.

We love knowing that someone is going to have a better life because of the work we do.

Worldwide is an equal opportunity employer that is committed to enabling professionals from all backgrounds and experiences to succeed and, to that end, we prioritize attracting diverse talent and cultivating an inclusive environment that encourages collaboration and creativity. We know that when our employees feel appreciated and included, they can be more creative,innovative,and successful. We’reon a mission to hire thevery bestand are committed to creating exceptional employee experiences where everyone is respected and has access to equal opportunity. We provide equal employment opportunities to all employees and applicants regardless of race, color, ethnicity, ancestry, religion, national origin, gender, sex, gender identity or expression, sexual orientation, age, citizenship, marital or parental status, disability, military status, or other class protected by applicable law .