CRA , ACE CRA Programme, United Kingdom

Job Description


Position: CRA 1, ACE CRA Programme, United Kingdom
ACE CRA Programme - United Kingdom IQVIA is a leading global provider of contract research services, advanced analytics and technology solutions to the life sciences industry formed through the merger of IMS Health and Quintiles.

Our ACE (Accelerated Clinical Excellence) program is a great way to kickstart your career within the clinical monitoring universeas it features a bespoke training and development plan to provide you with the best start to your career as a CRA in IQVIA, including Good Clinical Practice (GCP) and appropriate therapeutic, protocol and clinical research training which will help you perform at your best.

In addition to the training and development plan, we offer a mentor scheme for all our "graduates". By participating, you will receive guidance and support from a mentor within the business as your career progresses. Our focused approach to performance and career management also means that you will have regular meetings with your line manager throughout the year to keep your goals and career aspirations in clear view.

You'd be offered a permanent contract with car allowance, performance-based bonus, merit increases and IT equipment (iPhone and laptop included). You'd be home-based and you'd be traveling to sites at regional (sometimes national) level supporting major pharmaceutical companies whom are truly making a difference in patients' lives!

Essential Functions
Perform site monitoring visits (selection, initiation, monitoring and close-out visits) in accordance with contracted scope of work and regulatory requirements, i.e., Good Clinical Practice (GCP) and International Conference on Harmonization (ICH) guidelines.
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) verify that the Investigator's Site File (ISF) is maintained in accordance with GCP / ICH 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.

Bachelor's Degree or Master's Degree in scientific discipline or health care preferred.
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).
Experience with in CRO, hospital or nursing setting would be beneficial
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.
Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
Right to work in the United Kingdom and a valid driving license#CRASDAJD #BRAVEMINDSWANTED #JOBS.


COM/CRAAt IQVIA, we believe in pushing the boundaries of human science and data science to make the biggest impact possible to help our customers create a healthier world. The advanced analytics, technology solutions and contract research services we provide to the life sciences industry are made possible by our 70,000+ employees around the world who apply their insight, curiosity and intellectual courage every step of the way.

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