Devan Irvin, Mph Email & Phone Number

Hendersonville, Tn, Us

Birmingham, Alabama, United States

Coordinates and performs a variety of research and administrative activities required in the management of clinical trials research. Duties include:Assisting principal investigators and/or other members of the research team in the development of protocols, budgets, and plans for clinical research studiesInterpreting and applying regulatory and policy requirements to protocols and proceduresProvides support in recruiting, enrolling scheduling and follow up visits of clinical trial subjects. Helps to ensure adherence to Food and Drug Administration (FDA) and protocol guidelinesIdentifies potential problems and/or inconsistencies and informs supervisors as neededWorks with sponsors and grant/contract administrators to complete negotiation of clinical trials agreements. Responsible for working with the Clinical Trials OnCore team to enter patient visits into Oncore; ensure OnCore data quality related to patient status and patient visit calendar, patient registrations and assist patients with billing inquiries.

Birmingham, Alabama, United States

Processing financial disclosure forms (routing for signatures, scanning/saving, submitting to the sponsor)Submitting CVs, MLs, Good Clinical Practice training documentation, local laboratory certifications and protocol specific normal values to sponsorsRouting protocol and investigators brochure signatures pages for signatures (scanning/saving, submitting to sponsor)Processing and routing protocol specific delegation of authority logs for entries from core research team members (protocol specific)Submit interim monitoring visit follow-up letters to UAB IRBProcess and submit protocol amendments to PRC (if study is open to accrual), and respective IRBsPrepare/maintain regulatory binders for interim monitoring visits o Assist w/ addressing regulatory action items noted during interim monitoring visitProcess and submit continuing review reports to respective IRBsRevise consent forms and submit to sponsor for approval prior to submission to respective IRBs

Master Of Public Health - Mph, Epidemiology

Bachelor Of Science - Bs, Public Health