Senior Clinical Research Associate – CNS, Immunology

Worldwide Clinical Trials

. Lead site qualification, initiation, interim monitoring, management, and close-out activities in accordance with study protocols, GCP, applicable regulations, and SOPs .

Posted 11/6/2026full-timeRemote • GermanySeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive knowledge of clinical research principles, FDA and EU regulations, and ICH Guidelines while effectively managing site qualification, monitoring, and documentation. Proficient in coordinating study activities and mentoring staff to ensure compliance and data integrity.

Highest-signal resume keywords

Clinical Research Associate (CRA) ExperienceKnowledge of FDA and EU RegulationsProficiency in Microsoft Office and EDC SystemsFluency in English and Local Language(s)Leadership and Mentoring Skills

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Research PrinciplesRegulatory ComplianceData ManagementSite MonitoringProtocol ComplianceInvestigational Product AccountabilityCRF DesignStudy Documentation ManagementTherapeutic Area KnowledgeProblem-Solving

Soft Skills

Communication SkillsInterpersonal SkillsPlanning and OrganizationTime ManagementInitiative

Tools & Technologies

Microsoft OfficeIxRSEDC SystemsTrial Master File Documentation

Certifications & Qualifications

MD or Pharmacy QualificationTwo-Year College Qualification in Nursing or Life Sciences

Industry Keywords

Good Clinical Practice (GCP)Informed ConsentSource DocumentationSafety InformationStudy ProtocolsSite QualificationMonitoring PlansInvestigator MeetingsSite Staff TrainingTravel Requirements

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Lead site qualification, initiation, interim monitoring, management, and close-out activities in accordance with study protocols, GCP, applicable regulations, and SOPs
Review informed consent, source documentation, CRFs, safety information, and protocol compliance to protect patient safety and data quality
Resolve data queries with investigative sites
Maintain regulatory and site documentation
Manage investigational product accountability
Support timely and accurate study data
Coordinate site regulatory and ethics documentation, study materials, and Trial Master File documentation
Serve as a Lead CRA on global studies when required
Coordinate CRAs and contribute 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
Participate in investigator meetings and bid defenses
Contribute monitoring and site-management expertise to protocol and CRF design, process initiatives, and study team training

Requirements

What you’ll need

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
Extensive knowledge of clinical research principles and processes
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
Excellent communication, interpersonal, planning, organization, time-management, initiative, leadership, and problem-solving skills
Proficiency with Microsoft Office, IxRS, and EDC systems
Valid current passport and driving licence, with willingness to travel
Fluency in the local language(s) of the countries under responsibility
Proficiency in spoken and written English
Candidates must reside within Germany to support site visits and study activities
Approximately 6-8 days of travel to investigative sites per month

Benefits

Comp & perks

Collaborative and inclusive work environment
Growth and learning opportunities
Home-based/remote work arrangement
Opportunity to support global studies as a Lead CRA
Mentoring and training opportunities
Opportunity to contribute to monitoring plans, study tools, templates, and training
Opportunity to participate in investigator meetings and bid defenses