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.

• Carry out remote or on-site assessments to ensure adherence to protocols and regulatory standards.

• Manage essential clinical trial documentation and guarantee readiness for audits.

• Employ a risk-based monitoring strategy to oversee investigator sites.

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

• Ensure data integrity through reviews of source documents, source data verification, and case report forms.

• Evaluate investigational products through physical inventory checks and records examination.

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

• Maintain communication with investigative sites between monitoring visits and address any issues that arise.

• Engage in investigator meetings and identify potential investigators for client companies.

• Initiate clinical trial sites and provide recommendations concerning compliance.

• Conduct trial closeout procedures and retrieve trial materials.

• Ensure necessary documents are complete in accordance with ICH-GCP and relevant regulations.

• Perform on-site file evaluations.

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

• Update study management systems, such as Clinical Trial Management Systems.

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

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

• Complete administrative duties, including expense reports and timesheets.

• Assist with project publications/tools and offer suggestions to the project team.

• Contribute to process enhancement initiatives and other project activities.

⛳️ Requirements

• Bachelor’s degree in a life sciences discipline or a Registered Nursing certification, or an equivalent and relevant 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 clinical monitoring abilities.

• 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 capabilities.

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

• Excellent oral and written communication skills, including interactions with medical professionals.

• Strong customer focus, active listening skills, attention to detail, and ability to recognize underlying customer issues.

• Effective organizational and time management skills.

• Strong interpersonal skills.

• Flexibility and adaptability in various situations.

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

• Proficient in Microsoft Office and capable of learning relevant software.

• Good command of the English language, including grammar.

• Strong presentation skills.

🏝️ Benefits

• Competitive remuneration.

• Annual incentive plan bonus.

• Healthcare coverage.

• Employee benefits.

• Opportunities for career and personal development.

• An innovative, forward-thinking organization with excellent career prospects.

• A company culture that prioritizes integrity, intensity, involvement, and innovation.

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