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

📋 Description

• Oversee the advancement of clinical studies at investigative sites or through remote monitoring.

• Ensure that clinical trials are executed, documented, and reported in compliance with the protocol, SOPs, ICH-GCP, and relevant regulatory standards.

• Conduct site qualification, initiation, monitoring, and close-out visits in accordance with the monitoring plan, company and sponsor SOPs, ICH/GCP guidelines, and applicable regulations.

• Engage in investigators’ meetings.

• Draft site visit reports and follow-up correspondence for investigators.

• Establish and nurture productive relationships with investigators and site personnel to meet study goals, particularly patient recruitment targets.

• Execute source data verification.

• Ensure proper on-site storage, dispensing, and accountability of study drugs.

• Guarantee adequate collection of data and regulatory documents.

⛳️ Requirements

• Bachelor’s degree in a field pertinent to clinical research, nursing qualification, and/or equivalent experience.

• 5 to 8 years of experience in on-site clinical monitoring within the biotechnology, pharmaceutical, and/or contract research organization (CRO) sectors.

• Strong comprehension of ICH/GCP guidelines and relevant regulatory requirements.

• Excellent verbal and written communication abilities in English.

• Capacity to prioritize multiple tasks and perform under pressure while maintaining attention to detail and adhering to deadlines.

• Outstanding judgment and problem-solving capabilities.

• Willingness to travel to research sites approximately 65% of the time.

• Proficient in Microsoft Office applications (i.e., Word, Excel, PowerPoint).

• Experience in dermatology is considered an advantage.

• Must be legally authorized to work in Poland.