TRAININGS & QUALIFICATIONS SINCE 2011
- Electronic Diaries: sponsor- and vendor-provided training
- Using Icebaths: in-house training, sponsor, and lab training
- Centrifuge Training: by site, including cup size, RPMS, and calibrations
- EKG Acquisitions: site training per cardiologist; lead placement per sponsor recommendations; conducting
- EKG Transmission: per sponsor and vendor training; both computer/phone line
- Vitals: temperature, weight, height, BP and HR-all completed per protocol
- IATA: computer training; current certificate holder
- GCP CITI: current certificate holder
- Minimental Training: sponsor, national training
- EDC Experience: sponsor training of Medidata Rave
- IXRS: sponsor training; Perspective MyTrials, PPDI
- Lab Sample Processing: sponsor, central lab specific, local lab and site training
- Consenting patients
- Inclusion/Exclusion review
- Patient Recruitment
- Patient Retention
- Obtain Medical Records for PI review
- Maintain study supplies
- Watch over Rights and Welfare of the Patients
- Maintain required training per sponsor/protocol
- Assist in Audits (sponsor and/or FDA)
- Attends Investigator Meetings
- Maintain Drug Logs
- Dispense IP
- Assist the PI in delegated duties
- Administering questionnaires per protocol
- Entering Data into eCRF
- Resolving queries
- Protocol adherence
- Creating and Completing source documentation
- Drawing and Processing of labs
CLINICAL RESEARCH
2011 – 2015
• Randomized, Double-blind, Vehicle-controlled 2-Arm Trial of Topical PluroGel N for the Treatment of Patients with Mildly Infected Diabetic Foot Ulcer. PGN-1300
• Safety and Efficacy Evaluation of Topical AL 60371 Otic Suspension, 0.3% in the Treatment of Acute Otitis Externa. Alcon
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of CB-5945 for the Treatment of Opioid Therapy for Chronic Non-Cancer Pain. Cubist 02
• A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Long-Term Safety and Tolerability of CB-5945 for the Treatment of Opioid Induced Constipation in Adults Taking Opioid Therapy for Chronic Non-Cancer Pain. Cubist 05
• A Randomized, Double-Blind Study Comparing Oseltamivir versus Placebo for the Treatment of Influenza in Low Risk Adults.
• A Randomized, Double-Blind, Phase 2 Study Comparing the Efficacy, Safety and Tolerability of Combination Antivirals (Amantadine, Ribavirin, Oseltamivir) versus Oseltamivir for the Treatment of Influenza in Adults at Risk for Complications.
• A 24-Week, Double-Blind, Active- Controlled, Parallel Group, trial to assess the superiority of Oral Linagliptin and Metformin Compared to Linagliptin Monotherapy in Newly Diagnosed, Treatment- Naïve, Uncontrolled Type 2 Diabetes Mellitus Patients.