Jonathan Doege Email & Phone Number

Dallas, Texas, United States

• Validating patient/specimen information by cross-referencing in EHR as well as following study specific processing instructions detailing spin speed, duration, temperature, aliquot instructions and more.• Complicated samples including PBMC processing.• Storage and shipment of patient specimens, scheduling courier pick-ups and ensuring sample viability in transit.• Efficient sponsor query resolution via various sponsor portals.

Dallas, Texas, United States

Correspondence with IRB, IBC, and FDA for protocol related documents, including but not limited to Protocols/ Amendments, Consents, Investigational Drug Brochures, Protocol Deviations, Serious Adverse Events/ IND Safety Reports, Patient Materials, Continuing Review Reports, and addressing applicable queries related to these items.Development and maintenance of internal study specific document/ process tools.Submission of regulatory critical documents to sponsor.Receipt of Serious Adverse Event (SAE) reports and applicable queries from designated research staff and submission to sponsor.Review all Serious Adverse Events (SAEs) and IND Safety Reports and responsible for facilitation of unanticipated problem assessment per SOPs and Institutional Review Board (IRB) requirements.Record retention of study documents, including regulatory, pharmacy, CRFs, and study start-up / education tools.Completion and correction of CRFs / data queries, including signing database queries.Participation in monitor visit conduct including management of follow-up items.Participation in preparation/conduct of MQA/FDA audits.Interface with sponsors to address overall study needs and act as liaison between Mary Crowley (central office and clinics) and sponsors / CROs for assigned trials.

Dallas, Texas, United States

Maintain study specific regulatory files for all clinical trials and prepare files for long-term storage.Schedule and prepare for Interim Monitoring Visits (IMV), including schedule visits and appointments, create agendas and Case Report Form (CRF) Status Reports, and ensure regulatory file availability during visit.Maintain PMRD spreadsheets, and create and maintain reports from CTMS.Provide administrative support for PMRD.Create and maintain a variety of clinical trial specific tools.