Senior Clinical Research Associate, Vollzeit oder Teilzeit

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

📋 Description

• Execute site monitoring tasks, both on-site and remotely, utilizing a risk-based monitoring strategy.

• Ensure compliance with protocols, ICH-GCP, regulatory standards, and SOPs at investigator sites.

• Perform source data review (SDR), source data verification (SDV), case report form (CRF) assessments, and maintain accountability for investigational products.

• Recognize, document, escalate, and follow up on issues until resolution, employing root cause analysis and CAPA principles.

• Keep audit and inspection readiness at designated sites.

• Foster collaborative relationships with investigators and site personnel.

• Accurately document monitoring activities in timely, high-quality reports and follow-up correspondence.

• Maintain communication with sites between visits to facilitate issue resolution and data integrity.

• Update study systems, such as CTMS, in accordance with study conventions.

• Provide updates on trial status and metrics to the Clinical Team Manager.

• Assist in study start-up, investigator identification, site initiation, and study close-out activities.

• Participate in investigator meetings, audits, inspections, and project team discussions.

• Review site metrics and prioritize monitoring tasks based on risk assessment.

• Contribute to process improvement initiatives, mentoring efforts, and project-specific assignments as required.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field or equivalent qualification.

• At least 2 years of experience as a Clinical Research Associate / Monitor.

• Valid driver's license.

• Full right to work in Germany.

• Proficiency in German and English at C1 level; interviews will take place in German.

• Strong clinical monitoring capabilities with practical experience in risk-based monitoring.

• Excellent understanding of and adherence to ICH-GCP and relevant regulations.

• Solid knowledge of therapeutic areas and medical terminology.

• Well-developed critical thinking, problem-solving, and root cause analysis abilities.

• Strong written and verbal communication skills when interacting with medical professionals.

• High attention to detail and exceptional organizational skills.

• Ability to work independently while effectively contributing to cross-functional teams.

• Flexibility and adaptability in a fast-paced project environment.

• Proficient in Microsoft Office and capable of learning clinical systems (e.g., CTMS).

• Willingness to travel approximately 50–75% (depending on the study).

🏝️ Benefits

• Engage in high-quality global clinical trials across various therapeutic areas.

• Join a stable, well-established organization offering long-term career opportunities.

• Collaborate closely with experienced Clinical Trial Managers and project teams.

• Access clear development pathways (e.g., Senior CRA, Lead CRA, CTM).

• Enjoy flexible working models that promote work-life balance.

• Permanent employment opportunity.

• Options for full-time (40 hours/week) or part-time (32 hours/week) employment available.