FSP CRA, Level II

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

📋 Description

• Execute and oversee clinical monitoring and site management tasks.

• Carry out remote or in-person visits to ensure compliance with protocols and regulations.

• Oversee necessary clinical trial documentation and sponsor procedures.

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

• Implement risk-based monitoring, root cause analysis, and corrective/preventive measures.

• Ensure data accuracy through SDR, SDV, and CRF evaluations.

• Evaluate investigational product inventory and maintain records.

• Record observations and escalate issues until resolved.

• Stay in contact with investigative sites between monitoring visits.

• Engage in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and provide compliance recommendations.

• Conduct trial closeout and retrieve trial materials.

• Review essential documents and perform on-site file examinations.

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

• Update clinical trial management systems.

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

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

• Complete expense reports and timesheets.

• Assist in project publications and tools.

• Contribute to project initiatives and process enhancements.

⛳️ Requirements

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

• Approximately 1 year of experience as a clinical research monitor or successful completion of the PPD Drug Development Fellowship.

• Valid driver’s license where applicable.

• Demonstrated clinical monitoring abilities.

• Knowledge of medical/therapeutic areas and medical terminology.

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

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

• Competence in managing Risk Based Monitoring concepts and procedures.

• Excellent oral and written communication skills.

• Ability to effectively communicate with medical personnel.

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

• Strong organizational and time management abilities.

• Effective interpersonal skills.

• Flexibility and adaptability.

• Capability to work independently or within a team.

• Proficient in Microsoft Office and ability to learn relevant software.

• Good command of the English language and grammar.

• Strong presentation skills.

🏝️ Benefits

• Competitive salary.

• Annual incentive plan bonus.

• Healthcare coverage.

• Employee benefits.

• Opportunities for career growth and development.

• Innovative and forward-thinking company culture.

• Accessibility services and accommodations for job seekers with disabilities throughout the application process.