Clinical Research Associate II – FSP

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

📋 Description

• Execute and oversee clinical trials to ensure that both sponsor and investigator obligations are fulfilled in accordance with local regulations and ICH GCP standards.

• Evaluate the qualifications of investigative sites and commence, guide, monitor, and conclude clinical trials at these locations.

• Review and authenticate clinical trial data gathered either on-site or remotely.

• Provide updates on site status and maintain trial management tools and tracking systems.

• Ensure monitoring activity documentation is completed in line with SOPs and contractual commitments.

• Work in collaboration with clinical team members to address trial and clinical challenges.

• Identify and resolve site- and trial-related concerns following SOPs.

• Reconcile essential document site files.

• Conduct source document verification and address query resolutions.

• Evaluate the accountability, dispensation, and compliance of investigational products.

• Confirm SAE reporting is conducted as per trial specifications and ICH GCP guidelines.

• Maintain communication with investigative sites.

• Act as the primary observer/assessor of site activities.

• Facilitate audits and address audit findings.

• Perform related responsibilities such as protocol amendment submissions and negotiating investigator site budgets.

• Mentor junior-level CRAs and assist in the onboarding of new employees.

• Carry out additional clinical operations tasks and advanced negotiation clinical assignments as required.

• Collaborate with other functional areas to troubleshoot site issues and ensure trial timelines are met.

⛳️ Requirements

• Adherence to relevant local regulatory requirements and ICH GCP guidelines.

• Completion and proper documentation of all necessary training.

• Experience suitable for performing clinical research duties that are reasonably related.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Opportunities for professional growth and development.

• Comprehensive health and wellness benefits.

• Supportive work environment with a focus on team collaboration.