Senior Clinical Research Associate 1 (CRA)

About the role

IQVIA is hiring a Senior Clinical Research Associate 1 in Durham. The role performs monitoring and site management work so that study sites carry out the study correctly and report data as required by the protocol, regulations, guidelines and sponsor requirements. Experience in oncology, cardiovascular, renal, metabolic, CNS, obesity (GLP-1), diabetes, GI, MASH/NASH, dermatology or respiratory is sought.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) under the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan to improve predictability.
• Deliver 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.
• Produce visit reports, follow-up letters and other site management documentation.
• Liaise with the study team and, where applicable, support site recruitment plans 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.
• At least 2 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements and of GCP and ICH guidelines.

What we offer

• Base pay range of $90,200 to $190,000 depending on qualifications, location and schedule.
• Possible incentive plans, bonuses and other benefits depending on the position.