Clinical Research Associate, 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.

• Evaluate the qualifications of potential investigative sites.

• Launch clinical trials at investigative sites and guide site personnel on proper trial procedures.

• Conclude clinical trials at investigative sites.

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

• Provide consistent updates on site status to team members and trial management.

• Refresh trial management tools and relevant tracking systems as needed.

• Complete monitoring activity documentation as required by Standard Operating Procedures (SOPs) or contractual agreements.

• Collaborate with clinical team members to address trial and clinical challenges.

• Escalate site and trial-related issues until they are resolved or addressed.

• Conduct essential document site file reconciliation.

• Perform source document verification and resolve queries.

• Evaluate investigational product accountability, distribution, and compliance.

• Confirm Serious Adverse Event (SAE) reporting in accordance with trial specifications and ICH Good Clinical Practice (GCP) guidelines.

• Communicate effectively with investigative sites.

• Ensure that necessary training is completed and documented properly.

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

• Facilitate audits and address audit findings.

• Undertake related tasks such as submitting protocol amendments and negotiating Investigator site budgets.

• Mentor junior-level Clinical Research Associates (CRAs) and serve as a resource for new staff members.

• Execute additional clinical operations responsibilities and advanced negotiation tasks as assigned.

• Collaborate with other functional areas to resolve site issues and support trial timelines.

⛳️ Requirements

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

• Experience suitable for mentoring junior-level CRAs and acting as a resource for new employees.

• Competence in monitoring clinical trials, site qualification, initiation, instruction, closure, and data review both on-site and remotely.

• Proficiency in source document verification, query resolution, essential document reconciliation, and investigational product accountability.

• Capability to validate SAE reporting in line with trial specifications and ICH GCP guidelines.

• Ability to facilitate audits and resolve audit-related issues.

• Skill in negotiating Investigator site budgets when necessary.

• Ability to complete all required training and maintain documentation.

• Strong communication skills for interacting with investigative sites and collaborating with clinical team members.

• Proficiency in utilizing relevant clinical trial tracking and management systems.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Opportunities for professional development and career advancement.

• Flexible work schedules and remote work options.

• Competitive salary and performance-based incentives.

• Supportive team environment that values collaboration and innovation.