Clinical Monitor, Clinical Research Associate, CRA

ClinSol GmbH & Co. KG

. Organise, coordinate, and monitor clinical trials in accordance with ICH-GCP guidelines and internal SOPs .

Posted 9/30/2026full-timeRemote • GermanyJuniorMid-LevelWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in organizing and monitoring clinical trials in compliance with ICH-GCP guidelines and the German Medicinal Products Act (AMG), while effectively managing study data and regulatory submissions. Strong communication and organizational skills are essential for coordinating with study sites and maintaining documentation.

Highest-signal resume keywords

Clinical Research Associate ExperienceICH-GCP KnowledgeMicrosoft Office ProficiencyStudy Monitoring SkillsRegulatory Submission Experience

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Clinical Trial CoordinationStudy Data ManagementRegulatory Submission ActivitiesTrial Master File MaintenanceOncology Study Monitoring

Soft Skills

Organizational SkillsCommunication SkillsTeam SpiritIndependenceFlexibility

Tools & Technologies

Microsoft AccessMicrosoft Excel

Industry Keywords

Clinical TrialsGerman Medicinal Products ActICH-GCP GuidelinesEthics CommitteesStudy Sites

About the role

Key responsibilities & impact

Organise, coordinate, and monitor clinical trials in accordance with ICH-GCP guidelines and internal SOPs
Recruit, select, and train investigators and study sites
Conduct study initiation visits, routine monitoring visits (on-site / remote), and close-out visits at study sites throughout Germany
Communicate with study sites and maintain written documentation
Identify on-site issues and escalate them to the study sponsor
Prepare and submit documentation to ethics committees and competent authorities
Support correspondence activities
Monitor schedules and deadlines
Maintain study data in databases (Microsoft Access, Microsoft Excel)
Support regulatory submission activities and maintain the Trial Master File (TMF)

Requirements

What you’ll need

At least 1 year of experience as a Clinical Research Associate / Clinical Monitor
Excellent knowledge of ICH-GCP and the German Medicinal Products Act (AMG)
Excellent proficiency with standard PC applications, particularly Microsoft Office
Good written and spoken English skills
Excellent organisational skills, independence, flexibility, and reliability
Strong team spirit, communication skills, and an open-minded approach
Knowledge of monitoring oncology studies is an advantage

Benefits

Comp & perks

Varied and interesting role in a growing company
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