Senior Clinical Research Associate

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

📋 Description

• Execute and oversee clinical monitoring and site management functions

• Conduct both remote and on-site visits to evaluate adherence to protocols and regulatory standards

• Manage essential documentation, processes, and sponsor or monitoring-environment protocols

• Ensure clinical trials comply with approved protocols, ICH-GCP standards, applicable regulations, and SOPs

• Monitor investigator sites utilizing a risk-based approach

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

• Guarantee data integrity through source data review, source data verification, and CRF examination

• Evaluate investigational product inventory and documentation

• Record observations in timely reports and correspondence; escalate issues and resolve deficiencies

• Maintain communication with investigative sites between monitoring visits

• Execute monitoring activities in accordance with approved monitoring plans

• Engage in investigator payment processes and resolve findings

• Track trial progress and provide updates to the Clinical Team Manager

• Update and ensure quality of clinical trial management systems and reports

• Take part in investigator meetings and identify qualified investigators and sites

• Initiate clinical trial sites and offer compliance recommendations

• Ensure trial closure and retrieval of trial materials

• Keep complete essential documentation and perform on-site file assessments

• Assist with project publications, tools, newsletters, trip report evaluations, and CRA team discussions

• Promote communication among investigative sites, client organizations, and the project team

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

• Complete expense reports and timesheets

• Contribute to process enhancement initiatives and other designated project tasks

⛳️ Requirements

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

• An equivalent combination of suitable education, training, and/or directly related experience may be acceptable

• 2+ years of experience in clinical research monitoring

• Valid driver's license where applicable

• Proficient clinical monitoring capabilities

• Understanding of medical/therapeutic area knowledge and medical terminology

• Proven application of ICH GCPs, applicable regulations, and procedural documents

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

• Capable of managing Risk-Based Monitoring concepts and processes

• Effective verbal and written communication skills

• Strong interpersonal skills and meticulous attention to detail

• Excellent organizational and time management abilities

• Flexibility and adaptability to changing conditions

• Ability to work autonomously as well as collaboratively in a team

• Proficient in Microsoft Office and willing to learn necessary software

• Fluency in both Dutch and English

• Good presentation capabilities

• Ability to comply with specific sponsor/client/site requirements

• Willingness and ability to travel frequently, generally 60–80%, including regular drives to site locations and potential overnight stays

• Capable of working in office, laboratory, clinical, and/or home office settings and handling necessary personal protective equipment

🏝️ Benefits

• Fully remote work option available throughout The Netherlands

• Hybrid or office-based work arrangements

• Standard Monday–Friday work schedule