Clinical Research Associate, CRA

This is a fully remote position, open to applicants in United Arab Emirates (UAE).

📋 Description

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

• Conduct remote or on-site visits to investigator sites to evaluate compliance with protocols and regulations.

• Manage necessary documentation, sponsor procedures, and monitoring environments.

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

• Safeguard the rights and well-being of subjects while ensuring the reliability of data.

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

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

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

• Evaluate investigational product inventory and maintain records.

• Document findings in reports and letters, escalating deficiencies until resolved.

• Stay in contact with sites between visits to ensure protocol compliance, resolve issues, and record data promptly.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and provide recommendations for compliance.

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

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

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

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

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

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

• Complete expense reports and timesheets.

• Assist with project publications/tools and contribute innovative ideas.

• Engage in project work and initiatives aimed at process improvement.

⛳️ Requirements

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

• Previous experience equivalent to at least 1 year as a clinical research monitor, or completion of the PPD Drug Development Fellowship.

• Valid driver’s license where applicable.

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

• Demonstrated clinical monitoring skills.

• Familiarity with medical/therapeutic area knowledge and medical terminology.

• Working 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.

• Excellent oral and written communication skills, including interactions with medical personnel.

• Customer-focused with strong listening skills and attention to detail.

• Strong organizational and time management skills.

• Effective interpersonal skills.

• Flexibility and adaptability.

• Ability to work independently or collaboratively within a team.

• Proficient in Microsoft Office and capable of learning relevant software.

• Fluent in Arabic with very good English language and grammar skills.

• Strong presentation skills.

🏝️ Benefits

• Fully remote work arrangement.

• Standard Monday–Friday work schedule.