Senior CRA 1

IQVIA; United Kingdom; On-site; GBP 60,000 - GBP 80,000; Full time

Job summary

A global healthcare provider is seeking an experienced Senior Clinical Research Associate in Reading, UK. The role involves performing site monitoring visits, managing the progress of clinical studies, and ensuring adherence to regulatory standards. The ideal candidate will have a Bachelor's Degree, at least 2 years of on-site monitoring experience, and strong communication and organizational skills. Join the mission to improve patient outcomes through innovative healthcare solutions.

Qualifications

• Requires at least 2 years of on-site monitoring experience.
• Good knowledge of clinical research regulatory requirements.
• Proficiency in Microsoft Office tools.

Responsibilities

• Perform site monitoring visits according to project requirements.
• Manage the progress of studies by tracking submissions and approvals.
• Create and maintain documentation for site management.

Skills

On-site monitoring experience

Knowledge of GCP and ICH guidelines

Written and verbal communication skills

Organizational skills

Problem-solving skills

Time management skills

Education

Bachelor's Degree in scientific discipline or healthcare

Tools

Microsoft Word

Microsoft Excel

PowerPoint

Job description

Sr. CRA 1 - Single Sponsor Dedicated page is loaded## Sr. CRA 1 - Single Sponsor Dedicatedlocations: Reading, Berkshire, United Kingdomtime type: Full timeposted on: Posted Todayjob 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 atIQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence to the life sciences and healthcare industries. We create connections that accelerate the development and commercialization of innovative medical treatments. Everything we do is part of a journey to improve patient outcomes and population health worldwide.To get there, we seek out diverse talent with curious minds and a relentless commitment to innovation and impact. No matter your role, everyone at IQVIA contributes to our shared goal of helping customers improve the lives of patients everywhere. Thank you for your interest in growing your career with us.