Clinical Research Associate II

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

📋 Description

• Oversee and coordinate all facets of clinical monitoring and site management.

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

• Manage sponsor protocols and guidelines effectively.

• Ensure that trials comply with approved protocols, ICH-GCP standards, relevant regulations, and SOPs.

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

• Monitor investigator sites using a risk-based approach to monitoring.

• Utilize root cause analysis, critical thinking, and problem-solving to pinpoint site process failures and implement corrective/preventive actions.

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

• Evaluate investigational products through physical inventory checks and records assessment.

• Record observations in reports and letters, escalating any deficiencies to clinical management.

• Keep in touch with investigative sites between monitoring visits and follow through on issue resolutions.

• Engage in investigator meetings.

• Identify potential investigators and initiate clinical trial sites.

• Conduct trial close-out procedures and retrieve trial materials.

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

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

• Update study systems, including the Clinical Trial Management System.

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

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

• Complete expense reports and timesheets accurately.

• Assist with project publications/tools and share ideas for improvement.

• Contribute to project work and initiatives aimed at process enhancements.

⛳️ Requirements

• Bachelor's degree in a life science-related field or 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.

• A valid driver's license is required.

• Equivalency through a combination of relevant education, training, and/or related experience may be accepted.

• Demonstrated clinical monitoring capabilities.

• Familiarity with medical/therapeutic areas and medical terminology.

• Knowledge of 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 effectively.

• Excellent oral and written communication skills.

• Strong organizational and time management skills.

• Proficient computer skills, including Microsoft Office, with a willingness to learn relevant software.

• Proficient English language and grammar skills.

• Strong presentation skills.

• Ability to work collaboratively in a team or independently.

• Flexibility and adaptability in various situations.

• Willingness to travel frequently to site locations.

🏝️ Benefits

• Frequent travel, typically 60-80%, but may be higher for certain individuals, including potential extended overnight stays.

• Provision of personal protective equipment, including protective eyewear, garments, and gloves.