location_onReading, UK
watch_later Posted: Feb 26, 2024
Skills Required
Nice To Have skills
Job Description
JOB DESCRIPTION
Our Sponsor Dedicated (cFSP) team are growing, join us on our mission to drive healthcare forward!
What We Offer / USPs
- 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 organization
- 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
Responsibilities
- 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
- 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
Requirements
- You should be life science degree educated
- You have experience of independent on-site monitoring experience
- You've handled multiple protocols and sites across a variety of drug indications
- Flexibility and ability to travel
- Strong communication, written and presentation skills