Clinical Research Associate (CRA) - Sponsor Aligned

About the role

iQvia is looking for a Sponsor-Aligned Clinical Research Associate (CRA) in Overland Park. The role performs monitoring and site management work so that sites carry out their studies and report data as required by the protocol, regulations, guidelines and sponsor requirements.

Key responsibilities

• Carry out site monitoring visits (selection, initiation, monitoring and close-out) under the contracted scope of work and regulatory requirements, including GCP and ICH guidelines.
• Work with sites to adapt, drive and track the subject recruitment plan to make it more predictable.
• 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 and local regulations.
• Create documentation of site management, monitoring visit findings and action plans through visit reports, follow-up letters and other study documents.
• Liaise with the study team; 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 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.

The potential base pay range, annualized, is $74,500 to $175,100, depending on qualifications, location and schedule; incentives, bonuses and benefits may also apply.