Jessica Neumann
Clinical Research Associate cFSP model
- Role
- Clinical Research Associate at IQVIA
- Location
- Milwaukee, WI, US
- LinkedIn followers
- 500 followers
About Jessica Neumann
I have my Bachelors of Science in Nursing from the University of Minnesota where I…
Experience
Clinical Research Associate
Dec 2023 — Present
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. • 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 / 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.
Education
University of Minnesota School of Nursing
Bachelor's of Science, Registered Nursing/Registered Nurse
2015 — 2019
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