CRA2 (Freelancer)

About the role

IQVIA is looking for a freelance CRA2 to perform monitoring and site management work so that study sites carry out their studies correctly and report study data as required by the protocol, regulations, guidelines and sponsor requirements. The role is based in Illkirch-Graffenstaden.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and regulatory requirements such as 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 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 according to GCP and local regulations.
• Create and maintain documentation on site management, monitoring visit findings and action plans through visit reports, follow-up letters and other study documents.
• Liaise with study team members; may also support the 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; 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 provided by company training.
• Written and verbal communication skills with a 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, and iPhone and iPad where applicable.