Senior Clinical Research Associate - CNS - Immunology - Germany

Worldwide; Deutschland; Remote; EUR 70,000 - 110,000; Full time

Job summary

Worldwide Clinical Trials is hiring a Senior Clinical Research Associate (CNS - Immunology) for Germany. This home-based role covers site qualification through close-out with travel 6–8 days per month across Germany.

You will lead site activities, ensure protocol compliance, and mentor junior CRAs within global studies. The ideal candidate holds an MD or Pharmacy qualification (or equivalent) with several years of CRA experience and strong knowledge of FDA/EU regulations, ICH, and GCP.

Qualifications

• MD or Pharmacy qualification with CRA experience.
• Four-year college qualification in medical/biological/health/pharmacy with CRA experience.
• Two-year college qualification in nursing or life sciences with CRA experience.

Responsibilities

• Lead site qualification, initiation, interim monitoring, management and close-out per protocol.
• Review informed consent and source docs to protect patient safety and data quality.
• Coordinate regulatory and ethics documentation and trial master file materials.
• Mentor less experienced CRAs and contribute to planning and tools as needed.
• Collaborate with study teams and project management on milestones and deliverables.

Skills

Strong communication

Planning & organization

Leadership

Problem solving

English proficiency

Education

MD or Pharmacy qualification

Four-year college qualification in medical/biological/health/pharmacy

Two-year college qualification in nursing or life sciences

Tools

Microsoft Office

IxRS

EDC systems

Job description

## Senior Clinical Research Associate - CNS - Immunology - GermanyApply: Remote: Virtual Germany: Full time: Posted Today: JR102964Join 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 WorldwideBring your clinical monitoring expertise to studies where quality, patient safety, and strong site relationships matter. As a Senior Clinical Research Associate, you will take ownership of site activities from qualification and initiation through ongoing monitoring and close-out, helping ensure reliable data and protocol compliance. You will work closely with investigative sites and study teams, providing hands-on site management while assessing protocol adherence, informed consent, subject safety, and data quality. Your experience will also have an impact beyond your own sites. You may support global studies as a Lead CRA, coordinate and mentor other CRAs, contribute to monitoring plans and study tools, deliver training, and partner with Project Management on study milestones and deliverables. ## Where You'll WorkThis 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; or a four-year college qualification in a medical, biological, physical, health, pharmacy, or related science with at least 5 years of CRA experience; or 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.