Principal Clinical Research Associate - Full-Time or Part-Time Available

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

📋 Description

• Oversee monitoring activities for complex, high-risk, or strategically significant clinical trials utilizing a risk-based approach.

• Conduct both on-site and remote monitoring visits independently, in accordance with approved monitoring plans.

• Carry out and supervise SDR, SDV, and CRF reviews, ensuring the utmost standards of data accuracy and integrity.

• Assess investigational product accountability through thorough inventory checks and records evaluation.

• Ensure that essential documents are complete, ready for inspection, and in compliance with ICH-GCP and relevant German/EU regulations.

• Lead site initiation, maintenance, and close-out processes, offering expert guidance and recommendations.

• Utilize advanced root cause analysis (RCA), critical thinking, and problem-solving techniques to identify systemic issues at sites.

• Act as a reliable partner to investigative sites, sponsors, and internal project teams.

• Detect trends across sites and studies, providing strategic insights to the Clinical Team Manager (CTM).

• Ensure prompt and accurate updates in study systems (e.g., CTMS) and perform quality control reviews as necessary.

• Engage in investigator meetings and assist with investigator identification and feasibility assessments.

• Support the processes for investigator payments and manage trial financial oversight as applicable.

• Actively mentor, coach, and facilitate the development of both junior and senior Clinical Research Associates (CRAs).

• Contribute to project-specific and functional training programs.

• Spot opportunities for process enhancement and lead the implementation of improvements.

• Ensure timely and accurate completion of timesheets, expense reports, and all required documentation.

• Maintain regular communication with sites between visits to ensure ongoing compliance and address issues.

• Drive corrective and preventive actions (CAPAs) to resolution and actively mitigate risks.

• Produce high-quality monitoring reports and follow-up correspondence promptly.

• Serve as a key escalation contact for significant site issues, protocol deviations, and compliance risks.

⛳️ Requirements

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

• At least 5 years of experience as a Clinical Research Associate / Monitor.

• Valid driver’s license.

• Full legal right to work in Germany.

• Proficiency in German and English at C1 level.

🏝️ Benefits

• Flexible working models that promote work-life balance.

• Permanent employment.