Clinical Research Associate

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

📋 Description

• Carry out clinical monitoring tasks at trial sites following ICH guidelines, GCP, local regulations, and SOPs.

• Conduct monitoring activities for the selection, initiation, execution, recruitment, quality data collection, and timely conclusion of oncology/hematology clinical trials.

• Work in conjunction with the Regional Clinical Operations Manager to ensure adherence to study timelines and quality benchmarks.

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

• Assist in study startup and offer local expertise.

• Execute feasibility assessments, site identification, selection, and evaluation.

• Deliver protocol and study training to designated sites.

• Perform pre-study, initiation, routine monitoring, closeout, and co-monitoring visits.

• Complete reports for monitoring visits.

• Oversee site performance by tracking regulatory submissions, recruitment, CRF completion, and resolving data queries.

• Establish communication channels with sites and report on progress, issues, and recommended actions to Clinical Operations.

• Ensure studies and sites are prepared for inspections.

• Collaborate with study sites to achieve study milestones, including startup, recruitment, database analyses, and closeout.

• Facilitate Study Oversight Visits, site audits, and inspections as necessary.

• Assess site practices and escalate any quality or GCP concerns.

• Anticipate potential site challenges and suggest corrective and preventive measures.

• Foster a culture of operational excellence and innovation.

⛳️ Requirements

• Bachelor’s degree in a relevant scientific field with a minimum of 2 years of monitoring experience.

• At least 2 years of Clinical Research Associate (CRA) monitoring experience within the pharmaceutical or CRO sectors.

• Preferred experience in global oncology trials.

• Preferred experience in oncology/hematology trials.

• Comprehensive understanding of ICH and related regulatory guidelines.

• Exceptional communication and interpersonal abilities.

• Strong organizational skills with the capacity to prioritize and manage multiple tasks.

• Proficient in both English and German, in writing and speaking.

• Competent in Microsoft Word, Excel, MS Project, MS PowerPoint, and Outlook.

• Willingness to travel up to 60% of the time.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible working hours and remote work options.

• Generous vacation and paid time off policies.