Clinical Research Associate

This is a fully remote position, open to applicants in Germany.

📋 Description

• Operate effectively as a key member of a Project Team

• Initiate, oversee, and conclude study sites both on-site and remotely during the study execution

• Supervise clinical trials in accordance with company and sponsor SOPs, GCP, ICH guidelines, and relevant regulations

• Conduct monitoring activities to evaluate subject safety, data integrity, and quality

• Confirm informed consent procedures and adherence to the protocol

• Inspect electronic or paper CRFs and source documentation for validity and precision

• Ensure management and accountability of investigational products

• Compile Monitoring Visit Reports, document observations and corrective/preventive measures, update tracking systems, and escalate issues as necessary

• Communicate identified issues and required actions to study sites

• Submit site documents to eTMF or paper TMF and ensure proper maintenance of the Investigator Site File

• Engage in audit or inspection preparation and follow-up tasks

• Arrange, ship, and reconcile clinical investigative supplies when needed

• Keep CTMS and other project systems updated with accurate site-level information

⛳️ Requirements

• Bachelor’s Degree, preferably in life sciences or nursing; or equivalent qualification

• More than 1 year of relevant clinical experience or academic background related to clinical trials or clinical development activities

• Capability to thrive in a fast-paced environment with shifting priorities

• Fundamental knowledge of medical terminology and science related to assigned drugs and therapeutic areas

• Familiarity with Good Clinical Practice regulations and ICH guidelines

• Ability to work autonomously as well as collaboratively within a team-oriented organization

• Strong written and verbal communication skills

• Proficient in both English and German

• Exceptional organizational skills

• Technology proficient with solid software and computer skills

• Willingness and ability to travel up to 60-80%, including potential overnight and international travel

🏝️ Benefits

• Competitive compensation package

• Comprehensive benefits

• Opportunities for personal and professional development

• Collaborative and innovative work atmosphere

• Chance to make a meaningful impact in patients' lives