Profiles

Neha Vora

Administrative Assistant, Research Coordinator

TRAININGS & QUALIFICATIONS

  • GCP CITI: current certificate holder since 2016
  • IATA: computer training; current certificate holder since 2016
  • CPR: BLS certificate since 2016
  • EDC: sponsor training; Perspective MyTrials computer training since 2016
  • IXRS: sponsor training; Bracket since 2016
  • Centrifuge training: by site including cup size, RPMs, and calibrations since 2016
  • EDC Experience: sponsor training; includes Medidata Rave, DataLabs, InForm, Oracle, and Perspective MyTrials since 2016
  • Questionnaires: sponsor/national training; includes PAC-QOL, PAC-SYM, Disease Severity, Disease QOL, Global Symptom Relief, Global Pain Relief, MIDAS, PHQ-9, HIS-Q, IPSS since 2016
  • EKG Acquisitions: site training per cardiologist; lead placement per sponsor recommendations since 2016
  • Electronic Diaries: sponsor- and vendor-provided training since 2016
  • EKG Transmission: per sponsor and vendor training; both computer/phone line since 2016
  • CSSR-S: Sponsor and national training; certificate may be available since 2016
  • Vitals: include temp, wt, ht, BP, HR; site training; manual/automatic BP; oral, temporal, auricle temp since 2016
  • IXRS: sponsor training; Bracket, Perspective MyTrials since 2016
  • Centrifuge training: by site including cup size, RPMs, and calibrations since 2016
  • Lab Sample Processing: sponsor, central lab specific, local lab and site training since 2016
  • ERT Site Pad: training per sponsor/vendor since 2016
  • Rapid result Labs: include drug screening, nicotine, pregnancy, urine dip stick since 2016
  • Consenting patients since 2016
  • inclusion/Exclusion review since 2016
  • Patient Recruitment since 2016
  • Patient retention since 2016
  • Obtain Medical Records for PI review since 2016
  • Maintain study supplies since 2016
  • Watch over Rights and Welfare of the Patients since 2016
  • PK Ice baths: Preparing samples since 2016
  • Resolving queries since 2016
  • Protocol adherence since 2016
  • Creating and Completing source documentation since 2016
  • Drawing and Processing of Labs since 2016
  • Infusion Pump Settings since 2016
  • Blinded/Unblinded Pharmacists since 2016
  • PHT experience since 2016
  • Transmission of ultrasound, x-ray, CT scan, nuclear medicine, echo and DXA via Dicom since 2016
  • Assist in Audits (sponsor and/or FDA) since 2016
  • Attends Investigator Meetings since 2016
  • Monitor/Maintain temperature logs since 2016
  • Maintain Drug Logs since 2016
  • Dispense IP since 2016
  • Assist the PI in delegated duties since 2016
  • Administering questionnaires per protocol since 2016
  • Entering Data in to eCRF since 2016

CLINICAL RESEARCH

  • Prove – A 52 Week, open-label evaluation of the effects of sacubitril/valsartan (LCZ696) therapy on biomarkers, myocardial remodeling and patient – reported outcomes in heart failures with reduced left ventricular ejection fraction.
  • R-Pharm (CL04041025-CREDO 3): A randomized, Double-blind, parallel-group, placebo-controlled, multicenter Phase III Study of the Efficacy and Safety of Olokizumab in Subjects with Moderately to Severely Active Rheumatoid Athritis inadequately controlled by tumor necrosis factor alpha (TNF-a) Inhibitor Therapy
  • R-Pharm (CL04041023 – CREDO 2): A randomized, double-blind, parallel-group, placebo and active controlled, multicenter phase III study to the efficacy and safety of Olokizumab in subjects with moderately to severely active rheumatoid arthritis inadequately controlled by methotrexate therapy.
  • R-Pharm (CL04041024 – CREDO 4); A Mulit-center, open-label, Phase III study to the efficacy and safety of Olokizumab in subjects with moderately to severely active rheumatoid arthritis.
  • CoLucid COL-MIG 305 (Gladiator): An open-label, long-term, safety study of Lasmiditan (100mg and 200mg) in the acute treatment of Migraine.
  • CoLucid COL-MIG 302 (Spartan): A Study of three doses of Lasmiditan (50mg, 100mg and 200mg) compared to placebo in the acute treatment of Migraine.  A randomized, dounle-blind, placebo-controlled parallel group study.
  • Braintree BL 400-303: An open lable study of Chronic use of BLI400 Laxative in constipated adults.
  • ZOLL (90D0109): Heart Failure Optimization Study