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.

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

• Oversee necessary clinical trial documentation and procedures.

• Ensure trials adhere to approved protocols, ICH-GCP guidelines, applicable regulations, and SOPs.

• Monitor investigator sites utilizing a risk-based monitoring methodology.

• Utilize root cause analysis, critical thinking, and problem-solving skills to identify issues and implement corrective/preventive measures.

• Ensure data integrity through SDR, SDV, and CRF review during both on-site and remote monitoring activities.

• Evaluate the inventory and records of investigational products.

• Record observations in reports and letters, escalating deficiencies to clinical management as necessary.

• Maintain communication with investigative sites between monitoring visits and oversee issue resolution.

• Participate in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and provide recommendations as needed.

• Conduct trial closeout activities and retrieve trial materials.

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

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

• Update study systems, including Clinical Trial Management Systems.

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

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

• Complete administrative tasks such as expense reports and timesheets.

• Assist with project publications/tools and share ideas with the project team.

• Contribute to initiatives for process improvement and other project-related work.

⛳️ Requirements

• Bachelor's degree in a life sciences field, Registered Nursing certification, or an equivalent relevant formal 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.

• Established clinical monitoring skills.

• Familiarity with medical/therapeutic areas and medical terminology.

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

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

• Capability to manage Risk Based Monitoring concepts and processes.

• Effective oral and written communication skills.

• Strong organizational and time management capabilities.

• Excellent interpersonal skills and attention to detail.

• Adaptability and flexibility.

• Ability to work independently as well as collaboratively within a team.

• Proficient in Microsoft Office and a willingness to learn relevant software.

• Proficient English language and grammar skills.

• Strong presentation skills.

🏝️ Benefits

• Annual incentive plan bonus.

• Healthcare benefits.

• Employee benefits package.

• Opportunities for career development and advancement.

• Accessibility services/accommodations for job seekers with disabilities during the application process.