Brian Mcelrath Email & Phone Number

Apex, North Carolina, United States

North Carolina, United States

Performs remote site qualification, site initiation, site monitoring calls, and close-out visits ensuring regulatory, ICH-GCP and protocol compliance•Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans•Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes•May require knowledge of Good Pharmacoepidemiology Practices (GPP) and Good Epidemiologic Practices (GEP) guidelines for NIS and to adhere to a schedule of data collection from HCPs and patients for NIS, effectively employing technology for tracking•Assesses the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate•Demonstrates diligence in protecting the confidentiality of each subject/patient•Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues•Applies query resolution techniques remotely and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines•Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture•Assesses site compliance with electronic data capture requirements•May perform Remote Aggregated Data Review (RADaR) utilizing the appropriate tools to identify, respond and manage issues in line with the associated Work Instructions (WI), RADaR guideline and Clinical Monitoring Plan (CMP)/Site Management Plan (SMP) for assigned sites/project•Ability to identify trends within and across sites, escalating issues and trends to develop corrective actions / preventative actions

Austin, Texas, United States

Performs remote site qualification, site initiation, site monitoring calls, and close-out visits ensuring regulatory, ICH-GCP and protocol compliance•Uses judgment and experience to evaluate overall performance of site and site staff and to provide recommendations regarding site-specific actions; immediately communicates/escalates serious issues to the project team and develops action plans•Maintains a working knowledge of ICH/GCP Guidelines or other applicable guidance, relevant regulations, and company SOPs/processes•May require knowledge of Good Pharmacoepidemiology Practices (GPP) and Good Epidemiologic Practices (GEP) guidelines for NIS and to adhere to a schedule of data collection from HCPs and patients for NIS, effectively employing technology for tracking•Assesses the process of obtaining informed consent has been adequately performed and documented for each subject/patient as required/appropriate•Demonstrates diligence in protecting the confidentiality of each subject/patient•Assesses factors that might affect subject/patient’s safety and clinical data integrity at an investigator/physician site such as protocol deviation/violations and pharmacovigilance issues•Applies query resolution techniques remotely and provides guidance to site staff as necessary, driving query resolution to closure within agreed timelines•Utilizes available hardware and software to support the effective conduct of the clinical study data review and capture•Assesses site compliance with electronic data capture requirements•May perform Remote Aggregated Data Review (RADaR) utilizing the appropriate tools to identify, respond and manage issues in line with the associated Work Instructions (WI), RADaR guideline and Clinical Monitoring Plan (CMP)/Site Management Plan (SMP) for assigned sites/project•Ability to identify trends within and across sites, escalating issues and trends to develop corrective actions / preventative actions

Austin, Texas, United States

• Perform all aspects of in-house site management in accordance with good clinical practices • Conduct regularly scheduled site management calls with study sites to support the sites’ execution of their study responsibilities • Document and help follow to resolution, issues noted during site management contacts • Escalate to management any observed deficiencies or issues in a timely manner and in accordance with study communication and monitoring plan guidelines • Serve as the primary study contact for sites • Respond to ad hoc site requests for assistance • Assist sites with the resolution of outstanding data queries • Provide ongoing site training • Ensure study systems are updated per agreed study conventions (e.g., Clinical Trial Management System – CTMS) to ensure adequate communication to project team and sponsor • Play an active role within the clinical team to help reach project goals, achieve deliverables, and meet project timelines

Austin, Texas, United States

Austin, Texas, United States

Austin, Texas, United States