Experienced Clinical Research Associate
3 weeks ago
Clinical Research Associate (all levels) Sponsor Dedicated, Home Based, Ireland
Join us on our exciting journey
Remote/Hybrid/Office based working options.
Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward
As Clinical Research Associate you will be responsible 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.
Job Overview:
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) 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:
You should be life science degree educated. You have experience of independent on-site monitoring. You've handled multiple protocols and sites across a variety of drug indications. Flexibility and ability to travel. Strong communication, written and presentation skills.What is in it for you?
The chance to work on cutting edge medicines at the forefront of new medicines development. IQVIA has access to significant data pools allowing better site selection and recruitment. This helps drive performance of sites making the CRA role more efficient and discussions at site more productive. Next generation clinical development We offer genuine career development opportunities for those who want to grow as part of the organisation. We invest in keeping our teams stable, so workload is consistent. We can offer flexibility regarding site locations to minimize travel. We can also consider candidates looking for a 4-day working week. As a CRA you will receive an iPad and use of key developments such as site visit app’s, site visit report app’s that allow CRA’s to do their day job more efficiently.#LI-REMOTE
IQVIA is a leading global provider of advanced analytics, technology solutions and clinical research services to the life sciences industry. 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. Learn more at
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