Smitha Bobby Thomas Email & Phone Number

Austin, TX, US

Morrisville, NC, US

Morrisville, NC, US

• Review medical records to screen for potential patient enrollment into clinical trials
• Obtain informed consent from research patients
• Provide patient education about an investigational trial and cardiac electrophysiology in general to the patient and family members
• Gather patient information, obtain history, vital signs, review medication regimen as needed
• Perform clinical duties for the research patient as needed, i.e. basic neurological assessment, ECG, hallwalks, QOL interviews
• Case coverage for ablation procedures, LAA Closure procedures etc in the surgical lab for the research patients.

• Identify potential grant opportunities and assess their feasibility to support the research activities of the assigned department/division
• Lead staff in researching and identifying potential funders and creating strategies
• Provides support for preparing grant proposals
• Project Management for the upcoming project activities
• Helping with Neurology Conferences
• Helping clinical trial management team in the decision making process to select the best CTMS s/w

Pre-study: Preparation/review of study documents  Conducting feasibility study, site evaluation visit and creating reports  Ethics committee (IEC/IRB) dossier submission and further correspondence with EC and clarification of their queries. Conducting Site Initiation visit as per CRO/Sponsor SOP Training Clinical research coordinators and.

Worked as main CRA for Cardiology projects with responsibilities included but not limited to Investigator Selection, Site feasibility study, Documents collection for Ethics committee/ Regulatory submission, Site initiation, Training the study team at site, Study monitoring, Study close out, Communication with the sponsor, Review of data tables from the.

 Identifies, evaluates and recruits qualified potential subjects as per Inclusion /Exclusion criteria  Explaining the study procedure and obtaining Informed consent from the subjects  Filling of patient data in eCRF and responding to the queries  Maintaining Site Master File Corresponding with subjects for follow up visits Worked with Medical writing.

Competitive Intelligence for Janssen Cillag Pharmaceuticals

Princeton, New Jersey, US

Business Intelligence for Glaxo Smithkline (GSK) nutritional products.

Advanced Post Graduate Diploma In Clinical Research

Mba In International Bussiness Management

Bachelor Of Pharmacy (B.Pharm.)