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 either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP guidelines, and protocol requirements.

• Assess site and staff performance, providing tailored recommendations for improvement.

• Address serious issues promptly and formulate actionable plans.

• Confirm informed consent processes, uphold subject/patient confidentiality, and maintain safety and clinical data integrity.

• Evaluate site procedures and perform source document reviews.

• Validate the accuracy and completeness of clinical data in case report forms.

• Resolve queries both remotely and on-site while guiding site staff.

• Assist in the review and capture of clinical study data utilizing both hardware and software tools.

• Ensure compliance with electronic data capture protocols.

• Conduct reviews of investigational product inventory, reconciliation, storage, security, and dispensing as necessary.

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

• Document monitoring activities and maintain tracking systems for accountability.

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

• Oversee site-level activities, communications, budgets, and timelines for assigned tasks.

• Collaborate with study site personnel to ensure proper training and compliance for assigned sites and project team members.

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

• Facilitate audit readiness, prepare for audits, and follow up on action items.

• Complete required training and stay informed about relevant guidelines, regulations, and company SOPs.

⛳️ 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 relevant regulatory requirements.

• Proficiency in both German and English.

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

• Exceptional communication, presentation, and interpersonal abilities.

• Residing in the Berlin/Leipzig/Dresden area.

• Capability to manage necessary travel for monitoring visits.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged management team.

• Comprehensive training in technical and therapeutic areas.

• Peer recognition for contributions.

• Inclusive total rewards program.

• Emphasis on an inclusive culture.

• Reasonable accommodations provided when appropriate.