Profiles

Tabitha Maden

Senior Accounting Specialist

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.