UT Health - University of Texas Health Science Center at Houston "Where Creating the Best Hope for a Healthier Future Begins"
Coordinates and manages subject recruitment, site development, enrollment of human subjects and clinical trial monitoring
Additional Summary Specific to Job
An exciting opportunity is available for you to work in the Coordinating Center for Clinical Trials on an NIH clinical trial entitled "TCD With Transfusions Changing to Hydroxyurea (TWiTCH)" that compares two treatments for prevention of primary stroke in children with sickle cell anemia.
Primary responsibilities include:
- Maintain PDF versions of forms on Source Documents page of the website.
- Maintain materials on website page for all study committees.
- Data clean-up - routine and manual; maintain and check edit summary.
- Follow-up on data requests and monitor progress.
- Image documentation, storage, and transfer.
- Maintain data book and prepare reports for clinical sites and cores.
- Supervise two graduate assistants.
- Obtain and maintain UT Internal Review Board (IRB) approval and send adverse event reports to UT IRB.
- Develop and maintain protocol and standard operating procedures for lost-to-follow-up activities.
- Maintain manual of operations; maintain self-training module; and completion guidelines for eCRFs.
- Follow up and monitor adjudications.
- Prepare agenda, materials, minutes and action items.
- Maintain web resources; track paper status, prepare and submit manuscripts to journals; update and print publications report.
- Data capture, management and query status, routine monitoring of reports and annual technical report.
- Development, approval, implementation and periodic review of SOP's.
- Plan and run staff meetings.
- Prepare documentation; provide review panel with adjudication packets; coordinate neurology review process and coordinate the neurology-neuroradiology consensus teleconference.
- Study processes training and assist with data system training.
- Monitor TCD alert reports and processes.
- Triage hot-line questions.
- Maintain MOO, protocol, consents; links; numbered memos; presentations; source documents; minutes and agendas; study directory; tools; and training modules.
Bachelor's degree with a minimum of ten years relevant experience. Depending on clinical trial, an RN registered in the state of Texas might be required. Depending on clinical trial a Human subjects training certificate might be required. Pharmaceutical or clinical research strongly preferred. Bilingual ? English/Spanish preferred. In the event that an RN degree is required, the bachelor's degree may be waived.
A master's degree preferred. Must be a quick-learning team player who works well under pressure, has good interpersonal skills and exceptional communication skills, both written and oral. Knowledge of ACCESS, Excel, Word, RefWorks, and PowerPoint is required.
Located in the prestigious Texas Medical Center, UTHealth is the most comprehensive academic health science institution in the Southwestern...