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

• Perform remote and on-site evaluations to ensure adherence to protocols and regulatory standards

• Manage essential clinical trial documentation and guarantee readiness for audits

• Supervise investigator sites utilizing a risk-based monitoring strategy

• Employ root cause analysis, critical thinking, and problem-solving techniques to pinpoint process failures and necessary corrective/preventive actions

• Ensure data integrity through the review of source documents, source data verification, and case report form evaluations

• Evaluate investigational products through inventory assessments and record reviews

• Document findings and escalate deficiencies or issues until resolved

• Maintain communication with investigative sites between monitoring visits

• Carry out supervisory responsibilities as outlined in the approved monitoring plan

• Participate in investigator payments, meetings, site selection, site initiation, trial closure, and the retrieval of trial materials

• Confirm that critical documents are complete according to ICH-GCP and relevant regulations

• Conduct on-site reviews of documentation

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

• Update clinical study systems, including Clinical Trial Management Systems

• Facilitate communication between investigative sites, the client organization, 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, contributing to process improvement initiatives

⛳️ Requirements

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

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

• Valid driver’s license where applicable

• Demonstrated clinical monitoring abilities

• Familiarity with medical/therapeutic area knowledge and medical terminology

• Knowledge of ICH GCPs, relevant regulations, and procedural documents

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

• Proficiency in managing Risk Based Monitoring concepts and processes

• Excellent oral and written communication skills

• Customer-oriented, with strong listening skills and attention to detail

• Strong organizational and time management abilities

• Effective interpersonal skills

• Adaptability and flexibility

• Ability to work autonomously or collaboratively within a team

• Proficient digital literacy and solid knowledge of Microsoft Office

• Strong English language and grammar skills

• Effective presentation skills

🏝️ Benefits

• Competitive salary

• Annual bonus from incentive plans

• Healthcare coverage

• Employee perks

• Opportunities for career advancement and development

• Innovative and forward-thinking company culture

• Accessibility assistance or accommodations during the application process for candidates with disabilities