Clinical Research Associate, Level I

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

📋 Description

• Execute and oversee clinical monitoring as well as site management tasks.

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

• Administer sponsor procedures and guidelines within the FSP team.

• Ensure that trials are conducted in accordance with approved protocols, ICH-GCP guidelines, relevant regulations, and SOPs.

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

• Monitor investigator sites through risk-based monitoring, including root cause analysis and corrective/preventive actions.

• Guarantee data integrity by reviewing source documents, verifying source data, and assessing CRF accuracy.

• Evaluate investigational product inventory and maintain accurate records.

• Document findings in reports and letters, and escalate issues until resolved.

• Keep in touch with investigative sites between monitoring visits.

• Track trial progress, provide updates to the Clinical Team Manager, and maintain study systems/CTMS.

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

• Initiate clinical trial sites, ensuring adherence to protocol, regulatory, and ICH-GCP requirements.

• Oversee trial closeout processes and the retrieval of trial materials.

• Maintain complete essential documentation and conduct on-site file evaluations.

• Support project publications, tools, and other study-related tasks.

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

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

• Complete expense reports and timesheets accurately.

• Contribute to initiatives aimed at process improvement.

⛳️ Requirements

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

• 6 months to 1 year of experience as a clinical research monitor or similar experience.

• A valid full driver's license.

• Equivalent qualifications through a combination of relevant education, training, and/or directly related experience may be considered.

• Strong clinical monitoring skills.

• Familiarity with medical/therapeutic areas and medical terminology.

• Knowledge and application of ICH GCPs, applicable regulations, and procedural documents.

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

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

• Excellent oral and written communication skills.

• Ability to communicate efficiently with medical personnel.

• Strong customer focus, listening skills, and attention to detail.

• Proficient interpersonal, organizational, and time management skills.

• Flexibility and adaptability in various situations.

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

• Proficiency in Microsoft Office and the ability to learn relevant software.

• Good command of Dutch, French, and English language skills, including grammar.

• Effective presentation skills.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.