FSP CRA, Level II

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

📋 Description

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

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

• Organize necessary documentation and ensure readiness for audits.

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

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

• Ensure the accuracy of data through thorough source data reviews, source data verification, and case report form (CRF) assessments.

• Evaluate investigational products by reviewing physical inventory and associated records.

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

• Maintain communication with investigative sites in between monitoring visits.

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

• Engage in investigator payment processes and address any project team issues or findings.

• Take part in investigator meetings and identify potential investigators.

• Initiate clinical trial sites and provide recommendations for compliance.

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

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

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

• Update study systems, including Clinical Trial Management Systems.

• Facilitate 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 accurately.

• Assist with project publications/tools and contribute to initiatives aimed at process enhancements.

⛳️ 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 skills in clinical monitoring.

• 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.

• Capability to manage Risk-Based Monitoring concepts and processes.

• Excellent oral and written communication skills.

• Ability to effectively communicate with medical personnel.

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

• Strong organizational and time management abilities.

• Effective interpersonal skills.

• Adaptability and flexibility in various situations.

• Ability to work collaboratively in a team setting or independently.

• Proficient in digital literacy and solid knowledge of Microsoft Office applications.

• Proficient in English language skills and grammar.

• Strong presentation skills.

🏝️ Benefits

• Competitive salary package.

• Annual incentive plan bonuses.

• Comprehensive healthcare benefits.

• Employee perks and benefits.

• Opportunities for career advancement and development.

• Innovative and forward-thinking company culture.

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