CRA I/II

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, management, and close-out visits, either on-site or remotely.

• Ensure adherence to regulatory standards, ICH-GCP/GPP, protocol guidelines, and company SOPs/processes.

• Assess the performance of sites and site staff, providing recommendations and actionable plans.

• Verify informed consent, maintain subject/patient confidentiality, ensure safety, uphold protocol compliance, and safeguard clinical data integrity.

• Evaluate site processes and perform source document reviews.

• Validate clinical data in case report forms and address queries within agreed timeframes.

• Assist in the review, capture, and compliance of electronic clinical study data.

• Oversee investigational product inventory, including reconciliation, storage, dispensing, administration, labeling, and return as necessary.

• Review and reconcile Investigator Site Files with Trial Master Files, ensuring proper archiving of essential documents.

• Document monitoring activities through letters, trip reports, communication logs, and project documentation.

• Aid in subject/patient recruitment, retention, and awareness initiatives.

• Monitor observations, site status, action items, deliverables, budgets, and timelines.

• Coordinate with study site personnel to ensure training and compliance among site/project teams.

• Participate in investigator, sponsor, global monitoring, and clinical training meetings.

• Support audit readiness, preparation, and subsequent follow-up actions.

• For Real World Late Phase: assist sites throughout the study lifecycle, collaborate with sponsor affiliates, medical science liaisons, and local country staff, train junior staff, identify out-of-scope activities, and recommend potential sites.

⛳️ Requirements

• Bachelor's degree or RN in a relevant field, or a comparable combination of education, training, and experience.

• Familiarity with Good Clinical Practice/ICH Guidelines and other relevant regulatory requirements.

• Proficient computer skills and a willingness to adopt new technologies.

• Exceptional communication, presentation, and interpersonal abilities.

• Capacity to manage travel requirements of up to 75% regularly.

• Working knowledge of ICH/GCP Guidelines, applicable guidance, relevant regulations, and company SOPs/processes.

• Ability to carry out clinical monitoring and site management tasks on-site or remotely.

• For Real World Late Phase: understanding of local requirements for real world late phase study designs.

• For Real World Late Phase: skills in chart abstraction and data collection.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Training in technical and therapeutic areas.

• Recognition from peers.

• Comprehensive total rewards program.

• An inclusive workplace culture.

• Collaboration with colleagues worldwide.

• Remote work options (subject to pre-approval).