Sr. CRA 1 - Site Management

IQVIA LLC; Leeds; On-site; GBP 32,000 - 54,000; Full time

Job summary

IQVIA LLC is seeking a site-based Clinical Research Associate to manage monitoring activities and ensure regulatory compliance across trials in Leeds. You will track submissions, site recruitment, data queries and documentation, while maintaining TMF/ISF and liaising with the study team.

The role requires at least 2 years of on-site monitoring experience, solid knowledge of GCP/ICH, and excellent English communication.

Qualifications

• Minimum 2 years of on-site monitoring experience.
• Good knowledge of GCP/ICH guidelines and regulatory requirements.
• Proficient in MS Word, Excel and PowerPoint; comfortable with laptops and mobile devices.
• Written and verbal English communication skills; strong organizational abilities.

Responsibilities

• Manage progress of studies by tracking regulatory submissions, recruitment, CRF completion and data queries.
• Maintain TMF and ISF in compliance with GCP and local requirements; prepare visit reports and follow-up letters.
• Collaborate with study team; support site recruitment plans and financial aspects where applicable.
• Establish strong working relationships with coworkers, managers, and clients.

Skills

On-site monitoring experience

GCP/ICH knowledge

MS Word/Excel/PowerPoint

English language proficiency

Organizational & problem-solving

Time and financial management

Education

Bachelor's Degree in science or health care

Job description

site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues as appropriate.

• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. May support start-up phase. Ensure copies/originals (as required) site documents are available for filing in the Trial Master File (TMF) and verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and local regulatory requirements. Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. Collaborate and liaise with study team members for project execution support as appropriate. If applicable, may be accountable for supporting development of
  project subject recruitment plan on a per site basis. If applicable, may be accountable for site financial management according to executed clinical trial agreement and retrieve invoices according to local requirement. Qualifications Bachelor's Degree Degree in scientific discipline or health care preferred. Req Requires at least 2 years of on-site monitoring experience. Req Good knowledge of, and skill in applying, applicable clinical research regulatory requirements. i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines. Good therapeutic and protocol knowledge as provided in company training. Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint and use of a laptop computer and iPhone and iPad (where applicable). Written and verbal communication skills including good command of English language. Organizational and problem-solving skills. Effective time and financial

management skills.

• Ability to establish and maintain effective working relationships with coworkers, managers, and clients. Please note - this role is not eligible for UK visa sponsorship IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create intelligent connections to accelerate the development and commercialization of innovative medical treatments to help improve patient outcomes and population health worldwide. Learn more at IQVIA is committed to integrity in our hiring process and maintains a zero tolerance policy for candidate fraud. All information and credentials submitted in your application must be truthful and complete. Any false statements, misrepresentations, or material omissions during the recruitment process will result in immediate disqualification of your application, or termination of employment if discovered later, in accordance with applicable law. We appreciate your honesty and professionalism.