Senior Clinical Research Associate – FSP

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

📋 Description

• Coordinate and execute all facets of clinical monitoring and site management.

• Carry out remote or on-site visits to evaluate adherence to protocols and regulatory standards.

• Oversee the necessary clinical trial documentation and sponsor/monitoring-environment processes.

• Ensure compliance with approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

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

• Monitor investigator sites utilizing risk-based monitoring, root cause analysis, and corrective/preventive measures.

• Ensure data integrity through SDR, SDV, and CRF reviews during both on-site and remote monitoring.

• Evaluate investigational product inventory and associated records.

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

• Address deficiencies and follow up on issues until resolution.

• Keep in touch with investigative sites between monitoring visits.

• Conduct monitoring activities in line with approved monitoring plans and partake in investigator payments.

• Track trial progress, provide updates to the CTM, and refresh CTMS systems as needed.

• Perform quality-control checks on CTMS reports when necessary.

• Participate in investigator meetings and identify potential qualified investigators.

• Initiate clinical trial sites and ensure proper trial closeout and retrieval of materials.

• Verify that essential documents are complete and conduct on-site file reviews.

• Support project publications/tools, team initiatives, and any additional study tasks assigned by the CTM.

• Facilitate communication between investigative sites, clients, and the PPD project team.

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

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

• Contribute to initiatives aimed at process improvements.

⛳️ Requirements

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

• Prior experience equivalent to at least 2 years as a clinical research monitor.

• Valid driver's license where applicable.

• An equivalent combination of relevant education, training, and/or experience may be considered.

• Strong clinical monitoring capabilities.

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

• Understanding and application of ICH GCPs, pertinent regulations, and procedural documentation.

• Critical thinking, root cause analysis, and effective problem-solving abilities.

• Proficient in managing Risk-Based Monitoring concepts and procedures.

• Excellent oral and written communication skills when interacting with medical personnel.

• Customer-oriented with strong listening abilities and attention to detail.

• Strong interpersonal, organizational, and time management skills.

• Flexible and adaptable to changing situations.

• Capability to work independently as well as collaboratively within a team.

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

• Excellent command of the Hungarian language and grammar.

• Good proficiency in English language and grammar.

• Strong presentation skills.

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

• Capability to lift 40 lbs. without assistance.

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

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health, dental, and vision insurance.

• Opportunities for professional development and career advancement.

• Flexible work schedule and remote work options.

• Paid time off and holidays.