Clinical Research Associate I/II

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

📋 Description

• Execute and coordinate clinical monitoring and site management tasks.

• Perform remote and on-site visits to evaluate adherence to protocols and regulatory standards.

• Oversee necessary documentation, sponsor protocols, and monitoring environments.

• Ensure that trials comply with approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

• Monitor investigator sites using a risk-based approach to oversight.

• Utilize root cause analysis, critical thinking, and problem-solving skills to detect site process failures and implement corrective/preventive measures.

• Guarantee data accuracy through SDR, SDV, and CRF evaluations during both on-site and remote monitoring activities.

• Evaluate investigational product inventory and maintain accurate records.

• Record observations in reports and letters adhering to established business writing standards.

• Report deficiencies and issues to clinical management and ensure resolution is followed through.

• Maintain communication with investigative sites between monitoring visits.

• Carry out monitoring duties as per approved monitoring strategies.

• Engage in investigator payment processes and participate in investigator meetings.

• Identify potential investigators for client companies.

• Initiate clinical trial sites, ensuring compliance with protocols, regulations, and ICH-GCP standards.

• Conduct trial closeout procedures and retrieve trial materials.

• Confirm that essential documents are complete and maintained in accordance with ICH-GCP and relevant regulations.

• Perform on-site file assessments.

• Track trial progress and provide updates on status.

• Maintain accurate and current study systems, including Clinical Trial Management Systems.

• Foster communication among investigative sites, client companies, and internal project teams.

• Address company, client, and regulatory requirements, including audits and inspections.

• Complete expense reports, timesheets, and other administrative duties.

• Assist in the development of project publications and tools.

• Share insights and contribute to project work and process improvement initiatives.

⛳️ Requirements

• Bachelor’s degree in a life sciences-related discipline, Registered Nursing certification, or equivalent and relevant formal academic/vocational qualification.

• At least 2 years of comparable clinical monitoring experience in a clinical environment, including clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences area with formal training in medical terminology and anatomy.

• Monitoring experience specifically in Oncology.

• Valid driver’s license where applicable.

• Consideration of equivalency through a combination of suitable education, training, and/or directly related experience may be applied.

• Foundational knowledge of medical/therapeutic areas and understanding of medical terminology.

• Capability to achieve and maintain a working knowledge of ICH GCPs, relevant regulations, and procedural documents.

• Strong oral and written communication skills, including effective interaction with medical personnel.

• Good interpersonal abilities.

• Customer-oriented mindset, active listening skills, attention to detail, and capability to identify underlying customer concerns.

• Excellent organizational and time management skills.

• Flexibility and adaptability to change.

• Well-developed critical thinking, root cause analysis, and problem-solving skills.

• Ability to manage Risk-Based Monitoring concepts and processes effectively.

• Capacity to work independently or collaboratively within a team setting.

• Proficient in Microsoft Office and capable of learning new software as needed.

• Proficient in English and Polish language with strong grammar skills.

• Willingness to travel frequently to site locations, generally 60-80%, which may include extended overnight trips.

• Ability to work with exposure to biological fluids, infectious organisms, electrical office equipment, and fluctuating/extreme temperatures on rare occasions.

• Capability to use required personal protective equipment, including protective eyewear, garments, and gloves.

🏝️ Benefits

• Fully remote work arrangement.

• Full-time employment.

• Standard Monday to Friday work schedule.