Clinical Research Associate – FSP

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

📋 Description

• Oversee and coordinate all facets of clinical monitoring and site management.

• Conduct both remote and on-site visits to evaluate compliance with protocols and regulations, while managing documentation.

• Monitor investigator sites utilizing risk-based monitoring techniques, root cause analysis, critical thinking, and problem-solving skills.

• Ensure the accuracy of data through reviewing source documents, source data verification, and CRF analysis.

• Evaluate investigational products by examining inventory and reviewing records.

• Record observations in reports and correspondence, escalating any deficiencies until resolved.

• Maintain communication with investigative sites in between monitoring visits.

• Participate in investigator meetings and identify potential investigators in collaboration with the client company.

• Initiate clinical trial sites and provide recommendations where appropriate.

• Carry out trial closeout activities and retrieve trial materials.

• Ensure that essential documents are complete and perform on-site file reviews.

• Provide trial status tracking and progress updates to the Clinical Team Manager.

• Update study systems in accordance with established conventions.

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

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

• Complete expense reports and timesheets accurately.

• Assist with project publications and tools, contributing ideas to the project team.

• Take part in project work and initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences field, or Registered Nursing certification, or an equivalent relevant academic/vocational qualification.

• A minimum of 1 year of experience as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• A valid driver's license where applicable.

• Equivalency through appropriate education, training, and/or directly related experience may be accepted.

• Demonstrated clinical monitoring abilities.

• Familiarity with medical/therapeutic areas and medical terminology.

• Working knowledge of ICH GCPs, relevant regulations, and procedural documents.

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

• Capability to manage risk-based monitoring concepts and processes effectively.

• Proficient oral and written communication skills with medical personnel.

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

• Strong organizational and time management capabilities.

• Excellent interpersonal skills.

• Flexibility and adaptability to changing circumstances.

• Ability to work independently or collaboratively within a team.

• Proficient knowledge of Microsoft Office and the ability to learn necessary software.

• Strong English language and grammar proficiency.

• Effective presentation skills.

• Willingness to travel frequently, approximately 60–80%, with the potential for extended overnight stays.

• Ability to work with potential exposure to biological fluids and infectious organisms while utilizing required personal protective equipment.

🏝️ Benefits

• Reasonable accommodations for individuals with disabilities.

• Additional benefits and privileges associated with employment.