Tyrah Chatman Email & Phone Number

Nashville, Tn, Us

Nashville, Tn, Us

Thousand Oaks, Ca, Us

Thousand Oaks, Ca, Us

Horizon was acquired by Amgen in October 2023

Dublin, Ireland, Ie

San Diego, Ca, Us

* Actively participates in Inspection Readiness by ensuring assigned portions of the TMF are complete and accurate.* Serves as vendor Subject Matter Expert (SME) for the IRT vendor selected for the assigned study.*Periodically drives the bi-weekly meeting with the CRO Clinical Leads.*Actively supports European sites.*Performs in-house review of CRF data for completeness and accuracy and resolves data management/query issues with study sites and vendors as needed.* Reviews clinical data to ensure timely entry and readiness for data review meetings with CRO.*Supports and monitors clinical trials to ensure sponsor and investigator obligations are met and in compliance with the currently approved .*Assists in review and approval of monitoring reports.*Works with Technical Operations and/or CTAs to Initiate investigational product shipments as needed and ensures that supplies are adequate/appropriate for assigned studies and sites.*Work with assigned CTAs and CROs to ensure study activities are documented via confirmation letters, follow-up letters, trip reports, communication logs, and other required study documents as per SOPs and the Study Monitoring Plan.

Durham, North Carolina, Us

• Clinical Site’s main point of contact for assigned sites, accountable for quality and delivery of sites during the pre-SIV / start-up phase. • Manages country specific feasibility, and site pre-qualification and qualification activities. • Configures, distributes, collects, reviews, and approves country and site specific documents and essential regulatory documents (SRP). • Prepares and submits IRB/IEC and MoH/RA (if applicable) application(s) in accordance with country/regulatory/client requirements. • Assists with forecast, development, and management of plans and strategies for site activation, patient recruitment & retention. • Supports protocol amendments throughout the life of the study as required. • Maintains a working knowledge of and ensure compliance with applicable ICH-GCP Guidelines, international and local regulations, PAREXEL SOPs, other PAREXEL / Sponsor training requirements and study specific procedures, plans and training. • Actively participates in Investigator and other external or internal meetings, audits & regulatory inspections as required.

Durham, North Carolina, Us

• Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues• Involvement, when required, in other areas of study management and staff training. • Responsible for:o issue resolution o patient enrollment management o handling protocol, ICF and contract amendments o review site payments o drug/supply management o managing/coordinating/supporting clinical monitoring activities remotely, including investigator / site selection, collecting regulatory documentation, and data collection and entry in accordance with relevant SOPs and regulations.• Anticipate, identify and resolve issues for non-clinical aspects of assigned studies• Accountable for meeting applicable project timelines in accordance with the master contract• Contribute to the research and project team by mentoring new members, assist in preparation of projects tools, and share ideas/suggestions with team members• Works with Electronic Data Capture (EDC)• Performs some vendor management duties.• Provides support to Clinical Team Manager.

Dublin, Ie

• Identify, select, initiate, and close-out appropriate investigational sites for clinical studies.• Monitor those sites in order to ensure that studies are carried out according to the study protocol, ICON SOPs/WPs, applicable regulations and the principles of ICH-GCP • Involvement, when required, in other areas of study management and staff training. • Contribute to the review of ICON systems and procedures, as appropriate• Possessed the ability to conduct investigator file reviews.• Coaching and mentoring of monitoring competence to inexperienced/less experienced colleagues• Contribute to the culture of process improvement with a focus on streamlining our processes adding value to our business and meeting client needs• Completed some visit report review for junior staff.• Recognize, exemplify and adhere to ICON’s values which center around a commitment to People, Clients and Performance. • Independently and proactively coordinate the necessary activities required to set up and monitor a study.

• Interview prospective patients and verify all pertinent data, including but not limited to, health insurance, workers compensation, patient demographics to determinate benefits eligibility• Update relevant data in VISTA.• Use all available resources in advising patients of their legal entitlement and assist with the application process.• Make initial determination about whether veterans/or non-veterans meet legal/contractual requirements for medical benefits

Msph, Public Health

Bachelor Of Science - Bs, Biology/Biological Sciences, General