CRA II

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

📋 Description

• Execute and coordinate activities related to clinical monitoring and site management.

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

• Oversee necessary clinical trial documentation and implement sponsor-specific procedures.

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

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

• Employ root cause analysis and problem-solving techniques to pinpoint process failures and determine corrective/preventive measures.

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

• Evaluate the inventory and records of investigational products.

• Record observations in reports and correspondence, escalate deficiencies, and ensure issues are resolved.

• Maintain ongoing communication with investigative sites between monitoring visits.

• Carry out monitoring tasks in accordance with approved monitoring plans.

• Engage in investigator payment processes and attend investigator meetings.

• Investigate and follow up on findings.

• Identify potential investigators and initiate clinical trial sites.

• Conduct trial closeout activities and retrieve trial materials.

• Ensure that essential documents are complete and accessible.

• Conduct on-site file evaluations.

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

• Update study systems such as CTMS.

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

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

• Complete expense reports and timesheets.

• Contribute to project publications, tools, process improvement initiatives, and additional project work.

⛳️ Requirements

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

• A combination of appropriate education, training, and/or directly related experience may also be considered.

• Approximately 1 year of experience as a clinical research monitor.

• Valid driver's license when applicable.

• Demonstrated skills in clinical monitoring.

• Knowledge of medical/therapeutic areas and medical terminology.

• Familiarity with ICH GCPs, applicable regulations, and procedural documents.

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

• Capability to manage Risk Based Monitoring concepts and processes.

• Good oral and written communication skills.

• Organizational and time management capabilities.

• Effective interpersonal skills and strong attention to detail.

• Flexibility and adaptability in various situations.

• Ability to work independently as well as part of a team.

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

• Strong English language skills and grammar proficiency.

• Excellent presentation abilities.

• Willingness to travel frequently, generally 60–80%, with a stipulation of travel exceeding 75%.

• Capability to work in office, laboratory, clinical, and/or home office environments.

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

• Capacity to perform necessary physical activities, including prolonged standing or sitting, frequent mobility, bending, twisting, crouching, and light to moderate lifting.

• Ability to perform under pressure and manage multiple tasks simultaneously.

• Regular and consistent attendance is expected.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday-Friday work schedule.

• Option for a home office environment.

• Travel expenses likely associated with required business travel (not explicitly stated as a benefit).