Senior Clinical Research Associate (Single Sponsor Dedicated)

About the role

iQVIA cFSP, a sponsor-dedicated clinical research service, is looking for experienced Senior Clinical Research Associates in the UK, based in Reading. The role covers monitoring and site management so that sites run their studies and report data as required by the protocol, regulations, guidelines and sponsor requirements. The position is not eligible for UK visa sponsorship.

Key responsibilities

• Carry out 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 in line with project needs.
• 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 study documentation; liaise with the study team.
• If applicable, support the site-level recruitment plan and site financial management and invoice retrieval.

Required profile

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements such as GCP and ICH guidelines.
• Good therapeutic and protocol knowledge, as provided through 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 colleagues, managers and clients.

Required skills

• Proficiency in Microsoft Word, Excel and PowerPoint.
• Use of a laptop, and iPhone and iPad where applicable.