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 responsibilities are fulfilled in accordance with local regulatory standards and ICH GCP guidelines.

• Evaluate the qualifications of potential investigative sites and initiate, instruct, monitor, and conclude clinical trials at those sites.

• Review and confirm the accuracy of clinical trial data collected either on-site or remotely.

• Provide consistent updates on site status to team members and trial management, while also updating trial management tools.

• Complete monitoring activity documentation in line with SOPs and contractual obligations.

• Collaborate with clinical team members to swiftly address trial and clinical issues.

• Escalate site and trial challenges per SOPs until they are resolved or closed.

• Reconcile essential document site files.

• Conduct source document verification and resolve queries.

• Evaluate investigational product accountability, dispensation, and compliance.

• Confirm SAE reporting in line with trial specifications and ICH GCP guidelines.

• Maintain communication with investigative sites and update tracking systems accordingly.

• Ensure that necessary training is completed and appropriately documented.

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

• Facilitate audits and assist in audit resolution.

• Perform related duties such as submitting protocol amendments and negotiating investigator site budgets.

• Mentor junior-level CRAs and serve as a resource for newly hired employees.

• Support site performance responsibilities and undertake additional clinical operations tasks.

• Engage with other functional areas to resolve site issues and facilitate trial timelines.

• Carry out clinical tasks that require advanced negotiation skills.

⛳️ Requirements

• Proven experience in clinical trial monitoring and management.

• In-depth knowledge of ICH GCP guidelines and local regulatory requirements.

• Strong analytical skills and attention to detail.

• Excellent communication and interpersonal abilities.

• Capability to mentor and provide guidance to junior staff.

• Proficiency in clinical trial management software and tracking systems.

• Strong problem-solving skills and the ability to work under pressure.

• Advanced negotiation skills for clinical tasks.

🏝️ Benefits

• Competitive salary and performance-based incentives.

• Comprehensive health and wellness benefits.

• Opportunities for professional development and career advancement.

• Collaborative and supportive work environment.