CRA 2 - Single Sponsor Dedicated

IQVIA LLC; Manchester; On-site; GBP 35,000 - 55,000; Full time

Job summary

IQVIA LLC is seeking experienced Clinical Research Associates in the UK to monitor study sites and manage site activities in line with the protocol and regulatory requirements.

Responsibilities include site visits, regulatory tracking, and maintaining essential study documentation. Collaboration with the study team and escalation of quality issues are expected. Reading and Manchester locations imply field-based work with potential travel across the UK.

Qualifications

• Bachelor's Degree in scientific discipline or health care preferred.
• At least 1 year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• Good knowledge of regulatory requirements (GCP and ICH).
• Good therapeutic and protocol knowledge as provided in company training.
• Computer skills including Word, Excel and PowerPoint; use of laptop and mobile devices.
• Strong written and verbal communication in English.
• Strong organizational and problem-solving skills.
• Effective time and financial management skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope of work and GCP.
• Track regulatory submissions, recruitment, CRF completion and data queries; support start-up phase as needed.
• Maintain TMF and ISF with instruction and generate visit reports and follow-up letters.
• Collaborate with study team to support project execution and site management.
• Establish and sustain communication with sites; escalate quality issues when needed.
• May be accountable for site financial management under a trial agreement.

Skills

Written and verbal communication

Organizational skills

Problem solving

Time management

Financial management

Education

Bachelor's degree in scientific discipline or healthcare

Equivalent combination of education, training and experience

Tools

Microsoft Word

Microsoft Excel

Microsoft PowerPoint

Laptop

iPhone

iPad

Job description

Join Us on Our Mission to Drive Healthcare Forward

IQVIA cFSP (sponsor-dedicated) are seeking experienced Clinical Research Associates in the UK.

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.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Please note - this role is not eligible for UK visa sponsorshipIQVIA 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. 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.

Qualifications

• Bachelor's Degree Degree in scientific discipline or health care preferred.
• Requires at least 1 of year of on-site monitoring experience.
• Equivalent combination of education, training and experience may be accepted in lieu of degree.
• 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.

Summary

Location: Reading, Berkshire, United Kingdom; Manchester, United Kingdom; Livingston, West Lothian, United Kingdom; London, United Kingdom

Type: Full time