Ruby Dubey

About Ruby Dubey

A dedicated Homoeopathic Physician and Clinical Research Professional with strong…

Experience

1. Clinical Research Coordinator & Cra

   Target Institute Of Medical Education & Research Timer

   Jun 2015 — Present · Pune, IN

   Developing and writing trial protocols (outlining the purpose and methodology of a trial);• Designing data collection forms, known as case report forms (CRFs);• Coordinating with the ethics committee, which safeguards the rights, safety and well being of all trial subjects;• Managing regulatory authority applications and approvals that oversee the research and marketing of new and existing drugs;• Identifying and assessing the suitability of facilities to be used as the clinical trial site;• Identifying/selecting an investigator who will be responsible for the conduct of the trial at the trial site;• Setting up the trial sites, which includes ensuring each center has the trial materials, including the trial drug often known as the investigational medicinal product. • Verifying that data entered on to the CRFs is consistent with patient clinical notes, known as source data/document verification (SDV);• Writing visit reports and filing and collating trial documentation and reports;• Discussing results with a medical statistician, who usually writes technical trial reports;• Archiving study documentation and correspondence;• Review final reports and occasionally manuscripts for publication.Creating and writing trial protocols, and presenting these to the steering committee.Identifying, evaluating, and establishing trial sites, and closing sites down on completion of the trial.Training site staff on therapeutic areas, protocol requirements, proper source documentation, and case report form completion.Ordering, tracking, and managing IP and trial materials.Overseeing and documenting IP dispensing inventory, and reconciliation.Protecting subjects’ confidentiality, updating their information, and verifying IP have been dispensed and administered according to protocol.Implementing action plans for sites not meeting expectations.Ensuring compliance with SOPs and local regulations, and ICH and GCP guidelines-Physical and Remote Monitoring

Education

• VLCC

  CC Diet & Nutrition, A

  2015 — 2015

• Indian Institute of Counselling Psycology

  Diploma in Counselling Psycology, Psycology Counselling

  2017 — 2018

• BHMS

  Bachelor's Degree, BHMS ( Bachelor of Homoeopathic Medicien & Surgery)

  2006 — 2011

• PGDCRM

  PGDC Clinical Research & Data Management

  2014 — 2014

Skills

• Homoeopathic Consultant
• Life Sciences
• Clinical Trials
• Clinical Data Management
• Clinical Research
• Physicians
• Pharmacovigilance