Senior Clinical Research Associate (CRA) - Beijing

About the role

IQVIA is hiring a Senior Clinical Research Associate (Sr. CRA) in Beijing. The role performs site monitoring and site management so that study sites carry out the study as required by the protocol, applicable regulations and guidelines, and report study data as required by the sponsor.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan to improve predictability.
• 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 maintained according to GCP and local regulations.
• Create and maintain documentation such as visit reports, follow-up letters and action plans.
• Liaise with study team members; may support the start-up phase, develop site-level recruitment plans and handle site financial management and invoice retrieval where applicable.

Required profile

• Bachelor's degree in a scientific discipline or healthcare preferred; equivalent education, training and experience may be accepted.
• At least 2 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements, including GCP and ICH guidelines.
• Good therapeutic and protocol knowledge provided through company training.
• Written and verbal communication skills with a good command of English.

Required skills

• Proficiency in Microsoft Word, Excel and PowerPoint, and use of a laptop, iPhone and iPad where applicable.
• Organizational, problem-solving, time and financial management skills.
• Ability to build effective working relationships with coworkers, managers and clients.