Clinical Research Associate - Site Monitoring (CRA 1 & CRA 2)

About the role

iQVIA is looking for a Clinical Research Associate (CRA) to perform site monitoring and site management work in Lima, Peru. The role ensures that study sites carry out their studies and report study data as required by the protocol, regulations, guidelines and sponsor requirements.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) following 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 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, ICH and local requirements.
• 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, subject recruitment plan and site financial management and invoice retrieval where applicable.

Required profile

• Bachelor's degree in a scientific discipline or health care preferred.
• 6 months to 2 years of on-site monitoring experience, including monitoring visits and monitoring reports.
• Availability to travel and living in Lima, Peru.
• Good written and verbal communication skills, including English.
• Organizational, problem-solving, time and financial management skills, and ability to build working relationships.

Required skills

• Basic knowledge of GCP and ICH guidelines.
• Proficiency in Microsoft Word, Excel and PowerPoint, and use of a laptop, iPhone and iPad where applicable.