Clinical Research Associate

IQVIA LLC; Manchester; Hybrid; GBP 42,000 - 54,000; Full time

Job summary

IQVIA is seeking a Clinical Research Associate to support Oncology studies across the UK. You will perform on-site monitoring visits, ensure protocol training, and maintain open lines of communication with sites to manage expectations and issues.

Responsibilities include tracking regulatory submissions, recruitment progress, CRF completion, and TMF/ISF filing while upholding GCP and ICH standards. Travel to sites will be required as needed.

Qualifications

• Experience of independent on-site monitoring of Oncology trials (unblinded studies).
• In-depth knowledge of GCP and ICH guidelines for clinical research.
• Life science degree or equivalent industry experience.

Responsibilities

• Perform site monitoring visits (selection, initiation, monitoring and close-out) per scope and GCP.
• Collaborate with sites to support recruitment, training and ongoing project expectations.
• Manage site documentation, TMF ISF, and ensure regulatory filings are up to date.
• Evaluate site practices, identify quality issues, and escalate as needed.
• Track study progress: regulatory submissions, recruitment, CRF completion, and data queries.

Skills

On-site monitoring (Oncology)

GCP & ICH knowledge

Travel flexibility

Education

Life science degree or equivalent

Job description

IQVIA's Site Management (multi-sponsor) team are seeking a Clinical Research Associate to join us on our mission to help create a healthier world.The Clinical Research Associate will support Oncology studies and cover sites across the UKApply today and forge a career with greater purpose, make an impact and never stop learning!**Responsibilities*** 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.**Requirements*** Experience of independent on-site monitoring of Oncology therapeutic area for unblinded studies.* In depth knowledge of Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines* Life science degree educated or equivalent industry experience* Flexibility to travel to sites as required**\*Please note - this role is not eligible for 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 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.IQVIA 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.