Freelance Senior Clinical Research Associate

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

📋 Description

• Operate effectively as a member of a Project Team throughout the execution of clinical studies.

• Initiate, monitor, and close out study sites both on-site and remotely.

• Provide unmasked support as a Clinical Research Associate for designated clinical studies.

• Oversee the accountability of investigational products and manage unblinded site activities.

• Ensure compliance with protocols, prioritize subject safety, and maintain data integrity and quality.

• Confirm that informed consent procedures and protocol requirements are properly executed.

• Evaluate the validity and accuracy of electronic or paper CRFs and source documentation.

• Document monitoring visit actions, findings, and both corrective and preventive measures.

• Communicate identified issues to sites along with necessary action items.

• Submit site documents to the eTMF or paper TMF as required.

• Ensure the Investigator Site File is maintained in accordance with GCP, ICH, and local standards.

• Keep the CTMS and project systems updated with precise site information.

• Engage in preparations for audits and inspections, including follow-up actions.

• Order, ship, and reconcile clinical investigative supplies when necessary.

• Support Clinical Research or Project Managers with project tracking, monitoring plans, monitoring report reviews, and CRA resource management.

• Conduct Assessment Site Visits upon request.

• Mentor CRAs and develop training in therapeutic areas when needed.

• Take part in capabilities presentations.

• Collaborate with study teams, investigative sites, and sponsors to ensure timely deliverables while maintaining study blinding and data quality.

⛳️ Requirements

• Bachelor's Degree, ideally in life sciences or nursing, or an equivalent qualification.

• Over 5 years of independent monitoring experience on-site.

• A minimum of 1 year of experience as an unmasked monitor.

• At least 1 year of experience in Ophthalmology is preferred, particularly with retina indications.

• Capability to thrive in a fast-paced environment with shifting priorities.

• Familiarity with basic medical terminology and scientific principles related to assigned drugs and therapeutic areas.

• Knowledge of Good Clinical Practice regulations and ICH guidelines.

• Ability to operate independently and within a matrix team organization.

• Exceptional written and verbal communication skills.

• Proficiency in English and the local language.

• Strong organizational skills.

• Technologically proficient with solid software and computer skills.

• Possess qualities such as self-awareness, flexibility, a collaborative mindset, proactivity, analytical thinking, attention to detail, coachability, motivation, diplomacy, and facilitation skills.

• Capability to take ownership of assigned responsibilities.

• Experience managing complex or early-phase studies.

• Willingness to travel 60–80%, including overnight and international travel if applicable.

🏝️ Benefits

• Competitive compensation package.

• Comprehensive benefits.

• Opportunities for personal and professional growth.

• Collaborative and innovative workplace environment.

• Chance to positively impact patients' lives.