CRA I

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

📋 Description

• Conduct site qualification, initiation, interim monitoring, management activities, and close-out visits.

• Ensure adherence to regulatory standards, ICH-GCP/GPP, protocols, and site compliance.

• Assess site and site staff performance while effectively communicating or escalating critical issues.

• Confirm informed consent processes, maintain subject/patient confidentiality, and uphold safety and clinical data integrity.

• Perform source document reviews and validate clinical data in case report forms.

• Address queries both remotely and on-site while guiding site staff.

• Oversee the management of investigational product inventory, including reconciliation, storage, dispensing, and returns.

• Review Investigator Site Files and ensure they are consistent with Trial Master Files.

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

• Assist in strategies for subject/patient recruitment, retention, and awareness.

• Track observations, statuses, and action items until resolution.

• Manage activities at the site level, including communications, project deliverables, budgets, and timelines.

• Collaborate with study site personnel to ensure site teams are trained and compliant.

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

• Facilitate audit readiness and follow-up actions post-audit.

• In real-world late-phase studies, provide support to sites throughout the study lifecycle, perform chart abstraction and data collection, collaborate with sponsor affiliates and local staff, train junior staff, and identify potential sites.

⛳️ Requirements

• Bachelor’s degree or RN in a related 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.

• Outstanding communication, presentation, and interpersonal abilities.

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

• Solid understanding of pertinent regulations and company SOPs/processes.

• Proficient in performing clinical monitoring and site management activities either on-site or remotely.

🏝️ Benefits

• Opportunities for career development and advancement.

• Supportive and engaged line management.

• Comprehensive technical and therapeutic area training.

• Recognition from peers.

• Total rewards program.

• An inclusive workplace culture.