Clinical Research Associate

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits both on-site and remotely.

• Ensure compliance with regulatory standards, ICH-GCP/GPP guidelines, and specific protocols.

• Assess the performance of sites and their staff, making recommendations for site-specific improvements.

• Communicate and escalate significant issues while developing actionable plans.

• Verify informed consent procedures and safeguard the confidentiality of subjects/patients.

• Evaluate subject/patient safety, data integrity, protocol deviations, and pharmacovigilance matters.

• Perform reviews of source documents and confirm the accuracy and completeness of CRF data.

• Address queries both remotely and on-site, providing guidance to site staff.

• Ensure compliance with electronic data capture protocols.

• Manage investigational product inventory, reconciliation, and conduct storage/security assessments as necessary.

• Review Investigator Site Files and align them with the Trial Master File.

• Document monitoring activities and maintain comprehensive tracking systems.

• Assist in subject/patient recruitment, retention, and awareness initiatives.

• Oversee site-level activities and communication to achieve project objectives, deliverables, and timelines.

• Serve as the primary liaison with study site personnel or collaborate with a Central Monitoring Associate.

• Ensure that assigned sites and project-specific team members receive proper training and remain compliant.

• Participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Facilitate audit readiness, preparation, and follow-up actions.

• Complete required training as assigned.

⛳️ Requirements

• Bachelor’s degree or RN in a relevant field, or an equivalent combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other pertinent regulatory requirements.

• Prior monitoring experience in Germany, ideally within the oncology sector.

• Proficient computer skills with the ability to adapt to new technologies.

• Strong communication, presentation, and interpersonal abilities.

• Proficiency in both German and English.

• Residing in north-east Germany.

• Willingness to manage regular travel commitments of up to 75%.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• Inclusive workplace culture.

• Reasonable accommodations provided when applicable.