FSP CRA, Level II

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

📋 Description

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

• Carry out both remote and on-site visits to evaluate compliance with protocols and regulations.

• Oversee clinical trial documentation and maintain audit readiness.

• Apply a risk-based monitoring strategy for overseeing investigator sites.

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

• Ensure the accuracy of data through SDR, SDV, and CRF reviews.

• Evaluate the inventory and records of investigational products.

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

• Keep in touch with investigative sites between monitoring visits.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites in accordance with procedures and regulatory requirements.

• Conduct trial close-out activities and collect trial materials.

• Verify that 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 effective communication among investigative sites, the client company, and the PPD project team.

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

• Complete expense reports and timesheets.

• Assist with project publications and tools.

• Contribute to project initiatives and process enhancement efforts.

⛳️ Requirements

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

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

• Valid driver's license where applicable.

• Demonstrated clinical monitoring capabilities.

• Knowledge of medical/therapeutic areas and medical terminology.

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

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

• Proficient in managing Risk-Based Monitoring concepts and processes.

• Excellent oral and written communication skills.

• Ability to effectively communicate with medical professionals.

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

• Strong organizational and time management abilities.

• Effective interpersonal skills.

• Flexibility and adaptability in various situations.

• Capable of working independently or as part of a team.

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

• Strong English language and grammar skills.

• Effective presentation skills.

🏝️ Benefits

• Competitive remuneration package.

• Annual incentive plan bonus.

• Comprehensive healthcare coverage.

• Attractive employee benefits.

• Opportunities for career advancement and development.

• Innovative and forward-thinking company culture.

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