Sr. CRA 1 - Site Management

IQVIA LLC; Reading; On-site; GBP 42,000 - 56,000; Full time

Job summary

IQVIA LLC is seeking an on-site Clinical Site Monitor to ensure study sites conduct the protocol per regulatory standards. You will manage monitoring visits, data queries, and site documentation to support project milestones.

Ideal candidates have a bachelor’s in a scientific field or healthcare and at least 2 years of monitoring experience, with strong English communication and IT skills. This full-time role is based in the Reading/ Manchester area and involves regular site travel.

Qualifications

• Bachelor's degree in a scientific discipline or health care preferred.
• At least 2 years of on-site monitoring experience.
• Knowledge of GCP/ICH guidelines and clinical trial regulations.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per GCP and study protocol.
• Track regulatory submissions, recruitment/enrollment, CRF completion, and data query resolution; support start-up as needed.
• Maintain trial master file (TMF) and Investigator's Site File (ISF) and generate visit reports and follow-up letters.

Skills

English

Communication

Coordination

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

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. Requires at least 2 years of on-site monitoring experience. 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.

SummaryLocation: Manchester, United Kingdom; Reading, Berkshire, United Kingdom; London, United KingdomType: Full time