Senior Clinical Research Associate - CNS - Immunology - Germany

WCT Worldwide Clinical Trials GER GmbH; Deutschland; Remote; EUR 65,000 - 95,000; Full time

Job summary

Worldwide Clinical Trials is seeking a Senior Clinical Research Associate in CNS Immunology to support sites across Germany from a home-based setup. You will collaborate with sponsors and global study teams, traveling 6-8 days per month to monitor sites and ensure regulatory compliance.

The role requires an MD or Pharmacy degree with CRA experience, strong knowledge of GCP and FDA/EU regulations, and excellent communication and leadership skills.

Qualifications

• MD or Pharmacy qualification with at least 3 years of CRA experience.
• A four-year college qualification in a medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience.
• A two-year college qualification or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience.
• Experience in full-service monitoring preferred.
• Extensive knowledge of clinical research principles and processes, with a thorough understanding of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and SOPs.
• Fluency in the local language(s) of the countries under responsibility and proficiency in spoken and written English.

Responsibilities

• Lead site qualification, initiation, interim monitoring, management, and close-out activities in accordance with study protocols, GCP, applicable regulations, and SOPs.
• Protect patient safety and data quality by reviewing informed consent, source documentation, CRFs, safety information, and protocol compliance.
• Partner with investigative sites to resolve data queries, maintain regulatory and site documentation, manage investigational product accountability, and support timely, accurate study data.
• Coordinate site regulatory and ethics documentation, study materials, and relevant documentation for the Trial Master File.
• Serve as a Lead CRA on global studies when required, coordinating CRAs and contributing to monitoring plans, study‑specific tools, templates, and visit report reviews.
• Mentor less experienced CRAs and site staff through guidance, training, accompanied visits, and constructive feedback.
• Collaborate with Project Management and study teams to evaluate deliverables and milestones and participate actively in investigator meetings and bid defenses.
• Contribute monitoring and site‑management expertise to protocol and CRF design, process initiatives, and study team training.

Skills

Leadership

Communication

Planning

Time management

Interpersonal skills

Problem solving

Education

MD/Pharmacy

Bachelor in medical sciences

Nursing qualification

Tools

Microsoft Office

IxRS

EDC systems

Job description

Senior Clinical Research Associate - CNS - Immunology - Germany

Join a global Contract Resource Organization (CRO) where innovation meets purpose. At Worldwide Clinical Trials, we're driven by a shared commitment to improving lives through high-quality clinical research.

Our teams are empowered to think creatively, take ownership, and deliver meaningful work that helps bring life‑changing therapies to patients around the world. With more than 4,000 professionals across the globe, we foster a collaborative and inclusive environment where diverse perspectives are valued, growth is encouraged, and every contribution makes an impact. Whether you're building your career or bringing years of experience, you'll have the opportunity to learn, grow, and help shape the future of clinical research.

Make an Impact as a Senior Clinical Research Associate - CNS - Immunology - Germany at Worldwide.

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.

What You'll Do

• Lead site qualification, initiation, interim monitoring, management, and close-out activities in accordance with study protocols, GCP, applicable regulations, and SOPs.
• Protect patient safety and data quality by reviewing informed consent, source documentation, CRFs, safety information, and protocol compliance.
• Partner with investigative sites to resolve data queries, maintain regulatory and site documentation, manage investigational product accountability, and support timely, accurate study data.
• Coordinate site regulatory and ethics documentation, study materials, and relevant documentation for the Trial Master File.
• Serve as a Lead CRA on global studies when required, coordinating CRAs and contributing to monitoring plans, study‑specific tools, templates, and visit report reviews.
• Mentor less experienced CRAs and site staff through guidance, training, accompanied visits, and constructive feedback.
• Collaborate with Project Management and study teams to evaluate deliverables and milestones and participate actively in investigator meetings and bid defenses.
• Contribute monitoring and site‑management expertise to protocol and CRF design, process initiatives, and study team training.

What You'll Bring

• MD or Pharmacy qualification with at least 3 years of CRA experience;
• a four‑year college qualification in a medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience;
• a two‑year college qualification or equivalent education/training, preferably in nursing or life sciences, with at least 7 years of CRA experience;
• Experience in full-service monitoring PREFERRED.
• Extensive knowledge of clinical research principles and processes, with a thorough understanding of FDA and/or EU regulations and directives, ICH Guidelines, local regulatory requirements, and relevant SOPs.
• Strong knowledge of two to three therapeutic areas, sufficient to operate as a Lead CRA where appropriate.
• Excellent communication, interpersonal, planning, organization, time‑management, initiative, leadership, and problem‑solving skills.
• Proficiency with Microsoft Office, IxRS, and EDC systems.
• A valid current passport and driving licence, with willingness to travel.
• Fluency in the local language(s) of the countries under responsibility and proficiency in spoken and written English.

Discover the Difference

We love knowing that someone is going to have a better life because of the work we do. Discover the Difference at Worldwide Clinical Trials.

Explore additional opportunities on our careers page, visit http://www.worldwide.com/careers, or connect with us on LinkedIn.

This is who we are.

We’re a team of clinicians, scientists, and researchers who want to make healthcare better. We were founded on an unwavering commitment to authentic, personalized attention. And today, as CROs consolidate and the industry changes rapidly, that personalized attention is more important than ever. We all came to this industry for different reasons, from different walks of life. If you ask any one of us why we’re here, you’ll get a different answer. And that’s what makes us special.