Senior Clinical Research Associate, Client Dedicated

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

📋 Description

• Oversee and coordinate clinical monitoring and site management tasks.

• Perform remote or onsite visits to evaluate adherence to protocols and regulatory standards.

• Manage sponsor procedures and guidelines across various monitoring settings.

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

• Maintain audit readiness and foster collaborative relationships with investigational sites.

• Monitor investigator sites utilizing a risk-based monitoring strategy.

• Employ root cause analysis, critical thinking, and problem-solving techniques to pinpoint site process failures and implement corrective/preventive measures.

• Ensure data accuracy through SDR, SDV, and CRF reviews during both onsite and remote monitoring.

• Evaluate investigational products by reviewing inventory and records.

• Prepare timely reports and correspondence documenting observations.

• Escalate deficiencies and track issues until resolution.

• Maintain communication with investigative sites between monitoring visits.

• Execute monitoring activities in accordance with approved monitoring plans.

• Participate in investigator payment processes and attend investigator meetings.

• Assist in identifying potential investigators and initiating clinical trial sites.

• Conduct trial closeout activities and retrieve trial materials.

• Ensure that essential documents are thorough and compliant.

• Carry out on-site file reviews.

• Track trial progress and provide regular updates.

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

• Facilitate communication among investigative sites, the client company, and internal project teams.

• Address company, client, and regulatory requirements, as well as audits and inspections.

• Complete expense reports and timesheets.

• Assist with project publications and related tools.

• Contribute to project efforts and initiatives aimed at process improvement.

⛳️ Requirements

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

• Approximately 2 years of clinical monitoring experience or comparable experience in clinical trials, medical terminology, medical research, clinical research, health care, or a health sciences field with formal training in medical terminology and anatomy.

• Valid driver's license, if applicable.

• Basic understanding of medical/therapeutic areas and medical terminology.

• Ability to acquire and maintain a working knowledge of ICH GCPs, applicable regulations, and procedural documents.

• Strong oral and written communication skills.

• Excellent interpersonal, organizational, and time management skills.

• Customer-oriented with strong listening skills, attention to detail, and the ability to identify underlying issues.

• Adaptability and flexibility.

• Proficient in critical thinking, root cause analysis, and problem-solving.

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

• Capability to work independently or collaboratively within a team.

• Proficient with Microsoft Office and ability to learn relevant software.

• Strong English language and grammatical skills.

• Willingness to travel frequently, generally 60–80%, including potential extended overnight stays.

• Ability to work in office, laboratory, clinical, and/or home office environments.

• Capacity to use personal protective equipment and work with potential exposure to biological fluids and infectious organisms.

🏝️ Benefits

• Reasonable accommodations for individuals with disabilities during the application process, interviews, and employment.

• Equal employment opportunity protections.