FSP CRA, Level II

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

📋 Description

• Execute and coordinate clinical monitoring along with site management tasks.

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

• Oversee necessary documentation to ensure readiness for audits.

• Utilize a risk-based monitoring strategy to supervise investigator sites.

• Implement root cause analysis, critical thinking, and problem-solving techniques to identify failures in site processes and develop corrective/preventive measures.

• Ensure data integrity through Source Data Review (SDR), Source Data Verification (SDV), and Case Report Form (CRF) reviews during both remote and on-site monitoring.

• Evaluate investigational product inventory and maintain accurate records.

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

• Maintain communication with investigative sites between monitoring visits and follow up on unresolved issues.

• Carry out supervisory duties as per the approved monitoring plan.

• Engage in investigator payment processes and assist in resolving issues.

• Take part in investigator meetings and identify potential candidates for investigations.

• Initiate clinical trial sites and provide recommendations as necessary.

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

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

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

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

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

• Address requirements from the company, clients, and regulatory bodies, including audits and inspections.

• Complete expense reports and timesheets efficiently.

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

• Participate in initiatives for process improvement.

⛳️ 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 approximately 1 year as a clinical research monitor, or successful completion of the PPD Drug Development Fellowship.

• Possession of a valid driver's license where applicable.

• Demonstrated clinical monitoring capabilities.

• 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 abilities.

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

• Proficient oral and written communication skills.

• Ability to effectively communicate with medical professionals.

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

• Strong organizational and time management skills.

• Effective interpersonal abilities.

• Adaptability and flexibility in various situations.

• Capability to work both independently and as part of a team.

• Solid understanding of Microsoft Office and the ability to learn relevant software applications.

• Proficient English language and grammar skills.

• Strong presentation skills.

🏝️ Benefits

• Competitive salary package.

• Annual bonus through an incentive plan.

• Comprehensive healthcare benefits.

• A variety of employee perks.

• Opportunities for career advancement and development.

• A dynamic, innovative organization with a progressive company culture.