Senior/Clinical Research Associate

About the role

iQVIA is looking for a Senior/Clinical Research Associate to perform monitoring and site management work across Beijing, Shanghai, Guangzhou and other cities. The role ensures that sites carry out studies and report study data as required by the protocol, applicable regulations and guidelines, and sponsor requirements.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and GCP and ICH guidelines
• Work with sites to adapt, drive and track the subject recruitment plan so that project needs are met
• Administer protocol and study training to assigned sites and keep regular contact to manage project expectations and issues
• Evaluate the quality and integrity of site practices, escalate quality issues as appropriate and track regulatory submissions, recruitment, CRF completion and data queries
• Ensure site documents are available for the Trial Master File and that the Investigator's Site File is kept in line with GCP and local regulations
• Create and maintain documentation such as visit reports, follow-up letters and action plans
• Liaise with study team members; may also support site recruitment plans and site financial management and invoice retrieval where applicable

Required profile

• Bachelor's degree in a scientific discipline or health care preferred; equivalent education, training and experience may be accepted
• At least 1 year of on-site monitoring experience
• Good knowledge of GCP and ICH guidelines and good therapeutic and protocol knowledge
• Written and verbal communication skills, including good command of English
• Organizational, problem-solving, time and financial management skills, and ability to build working relationships with coworkers, managers and clients

Required skills

• Proficiency in Microsoft Word, Excel and PowerPoint
• Use of a laptop computer and iPhone and iPad where applicable