I have over 20 years of real world medical field experience. I have a strong passion for team building and hard work. I strive to be a constant professional and leader, with special attention to customers, patients and the public in general. I understand very well the concept of team work and leadership as I look for the most compatible, hard working and goal oriented individuals to surround myself with and promote an atmosphere of teamwork, reliability, and a mindset of solutions. I have have extensive experience in hiring, managing and training individuals who work with me or in my field. I additionally promote accountability and problem solving skills in all who work with me. Logistics, accountability, coordinating, deadlines and inventory are fields that I have mastered in my career. I'm looking forward to the next stage and evolution in my career and I'm extremely excited to put my efforts and skills and partner with Amazon.
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
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