Clinical Research Associate

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

📋 Description

• Perform clinical monitoring tasks at clinical trial sites.

• Oversee clinical trials in alignment with ICH guidelines, Good Clinical Practice (GCP), local regulations, and applicable Standard Operating Procedures (SOPs).

• Work closely with the Country and Regional Clinical Study Teams to ensure adherence to study timelines and maintain the required quality standards.

• Identify deficiencies and opportunities for enhancement, proposing Corrective and Preventive Actions (CAPA).

• Assist in start-up activities.

• Carry out site selection and assessment.

• Deliver protocol and related study training to designated sites.

• Conduct onsite or remote pre-study, initiation, routine monitoring, and closeout visits according to the monitoring plan.

• Generate and maintain necessary documentation related to site management, monitoring visit findings, and action plans.

• Oversee site performance by managing regulatory submissions, participant recruitment, case report form completion, and data query resolution.

• Ensure the study and sites are prepared for inspections.

⛳️ Requirements

• A minimum of 1 year of experience in oncology or onco-hematology trials.

• Strong understanding of clinical research regulatory requirements, including Good Clinical Practice (GCP), International Conference on Harmonization (ICH) guidelines, and related regulatory guidelines.

• Preferred experience in monitoring within the pharmaceutical or Contract Research Organization (CRO) industry.

• Experience specifically in oncology or onco-hematology trials is preferred.

• Exceptional communication and interpersonal abilities.

• Capability to build and sustain effective working relationships with colleagues, managers, and other internal or external stakeholders as necessary.

• Strong organizational and problem-solving skills, with the ability to prioritize and manage multiple tasks.

• Effective time management abilities.

• Proficient written and verbal communication skills, including a strong command of both the English and German languages.

🏝️ Benefits

• Health insurance.

• Flexible work hours.

• Opportunities for professional development.