Senior Clinical Research Associate

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

📋 Description

• Execute and oversee clinical monitoring and site management activities.

• Perform both remote and on-site visits to evaluate protocol and regulatory adherence.

• Oversee sponsor procedures, guidelines, documentation, and monitoring settings.

• Ensure that trials adhere to approved protocols, ICH-GCP guidelines, regulations, and SOPs.

• Safeguard subjects' rights, well-being, data integrity, and audit preparedness.

• Cultivate collaborative relationships with investigational sites.

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

• Employ root cause analysis, critical thinking, and problem-solving to identify issues and implement corrective/preventive measures.

• Verify data accuracy through source document reviews, source data verification, and CRF assessments.

• Evaluate investigational product inventory and maintain accurate records.

• Draft monitoring reports and correspondence; escalate and resolve deficiencies.

• Maintain ongoing communication with investigative sites between monitoring visits.

• Execute monitoring activities in accordance with approved monitoring plans.

• Engage in investigator payment processes and resolution of findings.

• Monitor trial progress and provide updates to the Clinical Team Manager.

• Update clinical study systems, including CTMS, and conduct quality-control checks on reports.

• Participate in investigator meetings and identify qualified investigators and sites.

• Initiate clinical trial sites and recommend compliance improvements.

• Conclude trials and recover trial materials.

• Ensure essential documents are complete and conduct on-site file evaluations.

• Assist with project publications, tools, team calls, trip report evaluations, and newsletters.

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

• Address company, client, and regulatory needs, audits, and inspections.

• Complete expense reports and timesheets.

• Contribute to initiatives aimed at process improvement.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field OR Registered Nursing certification OR an equivalent relevant formal academic/vocational qualification.

• Minimum of 2 years of experience as a clinical research monitor.

• Valid driver's license where applicable.

• Equivalency through a combination of suitable education, training, and/or directly related experience may be considered.

• Proficient clinical monitoring skills.

• Knowledge of medical/therapeutic areas and familiarity with medical terminology.

• Understanding and application of ICH GCPs, relevant regulations, and procedural documents.

• Familiarity with Risk-Based Monitoring concepts and processes.

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

• Excellent oral and written communication skills.

• Strong interpersonal, organizational, and time management capabilities.

• Exceptional attention to detail.

• Flexibility and adaptability in various situations.

• Ability to work independently as well as collaboratively in a team environment.

• Proficient in Microsoft Office and quick to learn relevant software.

• Strong English language and grammar skills.

• Effective presentation skills.

• Ability to meet sponsor/client/site requirements, including potential vaccination status or personal information disclosure.

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

• Capability to utilize required personal protective equipment.

🏝️ Benefits

• Fully remote work arrangement.

• Standard office hours (40 hours per week).