CRA Risk-Based Monitoring

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

📋 Description

• Conduct site qualification, initiate sites, perform interim monitoring, manage site activities, and carry out close-out visits, either on-site or remotely.

• Assess the performance of sites and site staff, providing recommendations for site-specific actions.

• Communicate significant issues to the project team, developing action plans as necessary.

• Ensure the integrity of informed consent processes, maintain subject/patient confidentiality, oversee safety, clinical data integrity, protocol compliance, and pharmacovigilance matters.

• Evaluate site processes and perform Source Document Reviews of site documentation and medical records.

• Validate clinical data entered in case report forms and ensure compliance with electronic data capture.

• Address queries both remotely and on-site within established timelines.

• Conduct inventory management, reconciliation, storage, dispensing, and administration reviews of investigational products.

• Review Investigator Site Files and ensure they are reconciled with the Trial Master File.

• Document monitoring activities through letters, trip reports, communication logs, and project documents.

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

• Monitor observations, site status, and action items until resolution.

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

• Serve as a liaison with study site personnel, ensuring that assigned sites and team members receive proper training and compliance.

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

• Aid in audit readiness and follow-up actions post-audit.

• Complete assigned training and stay informed about relevant guidelines, regulations, and company procedures.

⛳️ Requirements

• Bachelor’s degree or RN in a related discipline, 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, preferably within the oncology sector.

• Experience in risk-based monitoring is advantageous.

• Proficient computer skills and a willingness to adopt new technologies.

• Strong communication, presentation, and interpersonal abilities.

• Proficiency in both German and English.

• Willingness to travel up to 75% regularly for monitoring visits.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Peer recognition initiatives.

• Comprehensive total rewards program.

• A culture that promotes total self.

• Initiatives fostering diversity, inclusion, and belonging.