Senior CRA 1 - Site Management

About the role

IQVIA UK's Site Management team is growing and is hiring two Senior CRAs in Manchester. The role covers monitoring and site management so that sites carry out their studies and report study data as required by the protocol, regulations, guidelines and sponsor requirements.

Key responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) in line with the contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive and track the subject recruitment plan to improve predictability.
• 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 and maintain documentation such as visit reports, follow-up letters and action plans.
• Liaise with study team members; may also support site recruitment planning 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, including 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 work with coworkers, managers and clients.
• UK visa sponsorship is not available.

Required skills

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