Clinical Research Associate II, Dermatology – Rheumatology

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

📋 Description

• Oversee the advancement of clinical studies at investigative sites or from a remote location

• Ensure that clinical trials are performed, documented, and reported in accordance with protocols, SOPs, ICH-GCP, and relevant regulations

• Execute site qualification, initiation, monitoring, and close-out visits

• Engage in investigators’ meetings

• Draft site visit reports and follow-up correspondence to investigators

• Foster effective relationships with investigators and site personnel to meet study goals and patient recruitment targets

• Conduct source data verification

• Ensure proper on-site study drug storage, dispensing, accountability, data collection, and regulatory document gathering

• Review and authorize site visit reports

• Monitor site visit and trip report metrics and escalate concerns to project teams

• Propose solutions to identified challenges and collaborate with project managers for resolution

• Assist in the development of annotated site visit reports, clinical monitoring plans, and monitoring tools

• Support the preparation and creation of CRA training materials

• Provide mentorship to CRAs

• Conduct on-site quality control visits alongside CRAs

⛳️ Requirements

• Bachelor’s degree in a relevant field such as clinical research, nursing, or equivalent experience

• 2 to 5 years of experience in on-site clinical monitoring within the biotechnology, pharmaceutical, or contract research organization (CRO) industry

• Experience in Dermatology and/or Rheumatology

• Strong understanding of ICH/GCP standards and relevant regulatory requirements

• Excellent verbal and written communication skills in English

• Ability to manage multiple assignments and work under pressure while maintaining attention to detail and adhering to deadlines

• Strong judgement and problem-solving capabilities

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

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

• Experience in dermatology is preferred

• Candidates must have legal authorization to work in Poland

🏝️ Benefits

• Permanent full-time employment

• Paid vacation

• PPK (Employee Capital Plans)

• Health allowance

• Home-based work option with teleworking allowance

• Continuous learning and development opportunities

• Competitive career advancement prospects