Sr. CRA 1 - Site Management

IQVIA; Reading; On-site; GBP 45,000 - 60,000; Full time

Job summary

IQVIA UK is expanding its Site Management team and seeking two Senior CRAs to monitor sites and manage study data in line with protocol, regulations and sponsor requirements. You will perform visits, support recruitment plans, provide protocol training, and ensure TMF/ISF documentation is maintained.

The role requires monitoring experience, GCP/ICH knowledge, and strong communication. This is an on-site position in the UK, with emphasis on collaboration with study teams and sites to achieve

Qualifications

• Bachelor's degree in scientific discipline or health care.
• Good knowledge of, and skill in applying, regulatory requirements (GCP/ICH).
• Requires at least 2 years of on-site monitoring experience.
• Strong written and verbal English communication skills.
• Proficient in MS Word, Excel and PowerPoint; comfortable with laptop, iPhone/iPad.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per SOP and GCP.
• Collaborate with sites to drive and track subject recruitment plans.
• Administer protocol training and maintain communication with sites to manage expectations.
• Evaluate site quality and adherence to regulations; escalate issues as needed.
• Track regulatory submissions, recruitment, CRF completion, data queries and resolution; support start-up phase.

Skills

Attention to detail

Communication skills

Time and financial management

Relationship building

Education

Bachelor's Degree in scientific discipline or health care

Tools

MS Word

MS Excel

PowerPoint

iPhone/iPad usage

Job description

Join Us on Our Mission to Drive Healthcare Forward

IQVIA UK’s Site Management team is growing, and we’re hiring two Senior CRAs. Join us to build a meaningful career, drive real impact, and continue your professional growth.

Job Overview

Perform monitoring and site management work to ensure that sites are conducting the study(ies) and reporting study data as required by the study protocol, applicable regulations and guidelines, and sponsor requirements.

Essential Functions

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and Good Clinical Practice.
• Work with sites to adapt, drive, and track subject recruitment plan in line with project needs to enhance predictability.
• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.
• Evaluate the quality and integrity of study 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 https://jobs.iqvia.com

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.