Description
Syneos Health is seeking a CRA II to join their Clinical Solutions team in Kunming or Chengdu. As a CRA II, you will conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices.
Job Responsibilities:
- Conduct on-site and remote monitoring of clinical research studies to ensure compliance with widely accepted clinical practices, including reviewing study protocols, informed consent forms, and case report forms
- Develop and implement tools, procedures, and processes to ensure quality monitoring, such as creating monitoring plans, checklists, and templates
- Contribute to the design, implementation, and delivery of processes, programs, and policies, including participating in the development of standard operating procedures (SOPs) and training materials
- Manage defined components of projects or processes within the area of responsibility, such as coordinating site visits, tracking study progress, and resolving issues
- Ensure accurate and timely documentation of monitoring activities and findings, including writing monitoring reports, follow-up letters, and action plans
- Collaborate with cross-functional teams to support clinical trial operations, including working with investigators, site staff, and other stakeholders to ensure smooth study conduct
Qualifications:
- Bachelor's degree in a related field or equivalent experience
- Minimum of 2-4 years of experience in clinical research monitoring
- Strong knowledge of Good Clinical Practice (GCP) guidelines and regulatory requirements
- Excellent communication and interpersonal skills
- Ability to work independently and manage multiple priorities
- Proficiency in using clinical trial management systems and other relevant software
Certifications:
- Certified Clinical Research Associate (CCRA) or equivalent certification preferred
Necessary Skills:
- Attention to detail and strong analytical skills
- Problem-solving abilities and critical thinking
- Ability to work effectively in a team environment
- Strong organizational and time management skills
- Proficiency in Microsoft Office Suite