Sr. CRA 1 - Single Sponsor Dedicated

IQVIA LLC; Reading; Hybrid; GBP 45,000 - 60,000; Full time

Job summary

IQVIA is seeking a Senior Clinical Research Associate (cFSP sponsor-dedicated) in Reading to monitor sites and manage study data per protocol and GCP. You will coordinate monitoring visits, support recruitment plans, and ensure regulatory compliance across assigned sites.

The role requires at least 2 years of on-site monitoring, strong English communication, and solid organizational skills to oversee data quality, site collaboration, and documentation across trials.

Qualifications

• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of GCP/ICH guidelines.
• Excellent written and verbal English communication.
• Strong organizational and problem-solving abilities.
• Demonstrated time and financial management skills.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out visits) per scope of work and GCP.
• Drive site recruitment plans and track progress to improve predictability.
• Administer protocol training and maintain communication with sites.
• Evaluate site practices for protocol adherence and regulatory compliance.
• Track regulatory submissions, recruitment, CRF completion, data queries; support TMF activities.
• Create documentation and visit reports, follow-up letters, and study documents.

Skills

English communication

Organizational skills

Problem-solving

Time management

Relationship building

Education

Bachelor's degree in scientific discipline or health care

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Laptop

iPhone

iPad

Job description

## Sr. CRA 1 - Single Sponsor DedicatedApplylocations: Reading, Berkshire, United Kingdomtime type: Full timeposted on: Posted 8 Days Agojob requisition id: R1524547Join Us on Our Mission to Drive Healthcare ForwardIQVIA cFSP (sponsor-dedicated) are seeking experienced Senior 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.**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.comIQVIA 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.