Jeremy Glover Email and Phone Number

•Perform and coordinate assigned aspects of the clinical monitoring process in accordance with GCPs and global SOPs to assess the safety and efficacy of investigational products.•Independently schedule and performs site selection, initiation, interim, and close out monitoring visits along with preparing required documentation study documents and tools.•Provide protocol training to Principal Investigator and site personnel; serve as the primary site resource for protocol and procedural questions.•Ensure that each investigator understands his/her obligations in regards to the FDA 1572, ICH/Good Clinical Practices, FDA regulations governing the use of investigational products, details of the protocol and the CRFs and overall objectives and expectations with respect to their participation in the clinical trial.•Ensure proper essential documents are in place prior to trial start-up and on an ongoing basis throughout the study as part of the continuous file audit review process.•Perform source document verification of subject data to CRF data to ensure data consistency and integrity and the protection and welfare of human research subjects.•Generate and resolve data queries as required according to data collection timelines.•Identify and review protocol violations with investigators and implement corrective actions to ensure compliance with the protocol and applicable regulations (FDA/GCP/ICH/IRB).•Control investigational product accountability.•Control trial supply ordering, dispatch, return and destruction.•Author visit reports and follow up letters documenting observations, findings and recommendations as a result of monitoring activities.•Develop/maintain relationships with investigators, research centers, Sponsors and vendors.•Became proficient utilizing proprietary on-line, TMFs, EDC and doc management systems.