Clinical Research Associate Level 1/2 Senior - KunTuo

About the role

iQVIA is looking for a Clinical Research Associate (Level 1/2 Senior) for its KunTuo site in Shanghai. The role performs monitoring and site management so that sites run studies according to the protocol, applicable regulations and guidelines, and report data as required.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) following the contracted scope of work and GCP and ICH requirements.
• Work with sites to adapt, drive and track the subject recruitment plan to improve predictability.
• Administer protocol and study training, keep regular contact with sites and escalate quality issues.
• Track regulatory submissions and approvals, recruitment and enrollment, CRF completion and submission, 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, ICH and local requirements.
• Document monitoring visits, findings and action plans through visit reports, follow-up letters and other study documentation.
• Liaise with the study team; may support the start-up phase, site recruitment planning and site financial management and invoice retrieval.

Required profile

• Bachelor's degree in a scientific discipline or health care preferred; equivalent education, training and experience may be accepted.
• Some organizations require completion of a CRA training program or prior monitoring experience.
• Good therapeutic and protocol knowledge provided through company training.
• Written and verbal communication skills with a good command of English.

Required skills

• Basic knowledge of GCP and ICH guidelines and ability to apply them.
• 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.