Sr. Research Study Coordinator/Unit Leader Resume Example

Coordinate and support Physician Investigators and Nurse Specialist in implementing research studies. Recruit, Screen, Consent, Enroll and daily evaluation of AIDS/HIV+ and HCV patients and their related complexes for participation into research protocols. I am responsible for comprehension of inclusion and exclusion criteria of various protocols. Obtain all base-line medical history, laboratories data for patient's assessment at initial and follow up appointments. Review patient medical records; view via CERNER Works (JHM) system. Provide AIDS/HCV patient education about related complexes as they relate to the research. Under strict supervision of PI, I am responsible for assessment of toxicity, AE/SAEs and subsequent dose reductions or termination of study drug as required per protocol.

Duties are as follows:

*Hire,Manage, train University of Miami Health Systems unit personnel.
 Travel for Sponsor's Investigator meetings; Attend Site Initiation meetings and Teleconferences
 Prepare for on Site Initiation Visit for thesponsor
 Complete study related trainings as required protocol such as:
o EDC training
o Certification for ECG Acquisition and transmission
o IVRS study Drug Management
o Pulmonary Training
o Electronic Diary Log In (LOG PAD)
 Consent and Inform patients of studies or Re-consent on any updated protocol amendments
 Work with PI and Sponsor to submit new studies, deviations and continuing reviews to IRB
 Ensure Research Pharmacy has received study drugs, Obtain study lab kits and supplies
 Dispense and do study drug accountability for Research Pharmacy; Counsel patients on study drug compliance
 Prepare patient records and Case Report Forms(CRFs) for the study monitors visits; Enter study related data Via EDC and correct outstanding queries
 Perform all close out procedures when studies have ended and store all patient's records as per sponsor and the FDA
 Prepare for any internal or FDA audits