Clinical Research Associate II

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

📋 Description

• Conduct qualification, initiation, monitoring, and termination visits at designated clinical sites.

• Create visit and contact reports.

• Establish and nurture relationships with site personnel.

• Serve as the primary contact for clinical sites, addressing and resolving issues and inquiries.

• Ensure study integrity while fostering positive relationships with site staff.

• Review trial performance and protect the rights and well-being of human subjects in compliance with protocols.

• Collaborate with clinical sites to develop patient recruitment strategies that align with enrollment timelines.

• Guarantee adherence to SOPs, protocols/amendments, GCP, and relevant regulatory requirements.

• Assess the quality and integrity of reported data, site effectiveness, and medication accountability.

• Monitor the completeness and quality of regulatory documentation.

• Conduct verification of site documents.

⛳️ Requirements

• Experience in Site Management or a similar role within clinical research.

• Knowledge of clinical trial methodologies and terminology.

• Capability to independently execute all clinical monitoring activities.

• Previous experience with Oncology trials is preferred.

• Bachelor’s degree or equivalent in biological sciences, pharmacy, or another health-related field.

• Excellent interpersonal, written, and verbal communication skills in a collaborative team environment.

• Proactive work ethic, urgency in task execution, and ability to operate with minimal supervision.

• Client-oriented mindset with a flexible attitude towards tasks and learning opportunities.

• Proficient in managing multiple responsibilities, navigating unpredictable scenarios, and meeting project deadlines.

• Ability to interpret and apply study protocols effectively.

• Ethical and honest approach to work.

• Strong computer proficiency, including CTMS, EDMS, Excel, and Word.

🏝️ Benefits

• Access to world-class technology and training tailored to individual experience.

• Reduced travel requirements and a lighter protocol load compared to industry competitors.

• Participation in a bonus incentive program.

• Opportunities to work across various therapeutic areas.

• Career development prospects in clinical research.

• Flexible working arrangements.