FSP CRA, Level II

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

📋 Description

• Execute and coordinate clinical monitoring and site management activities.

• Conduct both remote and on-site visits to evaluate protocol and regulatory compliance.

• Oversee the necessary clinical trial documentation and procedures.

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

• Monitor investigator sites using a risk-based monitoring strategy.

• Utilize root cause analysis to identify failures in site processes and determine corrective/preventive actions.

• Ensure data integrity through source data review, source data verification, and CRF review.

• Evaluate investigational product inventory and documentation.

• Record observations in reports and letters, escalating deficiencies until resolved.

• Maintain communication with investigative sites between monitoring visits.

• Carry out supervisory tasks in accordance with monitoring plans.

• Engage in investigator payments, meetings, site selection, site initiation, and trial closeout.

• 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 clinical trial systems in line with study conventions.

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

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

• Complete expense reports and timesheets.

• Contribute to project publications, tools, process enhancements, and other initiatives.

⛳️ Requirements

• Bachelor's degree in a life sciences-related field, or 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 skills.

• 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.

• Excellent oral and written communication skills.

• Customer-focused with good listening skills, attention to detail, and ability to identify underlying customer issues.

• Strong organizational and time management skills.

• Interpersonal abilities.

• Flexibility and adaptability.

• Ability to work independently or collaboratively within a team.

• Proficiency in Microsoft Office and the ability to learn relevant software.

• Good command of the English language and grammar.

• Strong presentation skills.

🏝️ Benefits

• Annual incentive plan bonus.

• Healthcare benefits.

• Employee benefits.

• Opportunities for career growth and development.

• An innovative and forward-thinking company culture.

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