Smitha Bobby Thomas Email & Phone Number

Austin, Tx, Us

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.• Instructing patients their medication changes after the procedure and conducting the follow up as per the protocol.• Medical record abstraction for research data, and EDC data entry as primary coordinator for the study• Preparing for monitoring visits• Promote communication and supportive interaction between healthcare providers• Communicate with other health care providers and relay all pertinent patient information to the physician so that he/she is kept abreast of the patient’s status• Making sure the research patient information and study data are properly stored and shredded as required.

• 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• Identifying contacts and gathering information for business development team

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 investigators at site. Up to date with all clinical trial unit SOP’s and other study related documents Study Monitoring: Planning and conducting monitoring visits  Ensure protocol compliance at Site and CRO  Monitor and track patient enrolment, and study progress  Quality data generation: eCRF review, query generation, evaluation of clarification provided, closing/routing the discrepancies Submit follow up report and monitoring reports to sites and sponsor respectively Ensure reporting of AE’s and SAE’s as per the time line to sponsor and ethics committee. Study Closeout: Ensure complete collection and review of data  Ensure all study documents are complete and properly filed Review of ISF, SMF and TMF for completeness at Site and CRO  Investigator fees and other financial clearance for participating sites  Submission of complete project expense to business developmentProject Management: Serve as primary contact for the sponsor, and communication to the sponsor on timelines and the project progress Communication and correspondence with site, data management, statisticians and other vendors Investigational product accountability tracking at all the sites and ensure availability of the same Provide/arrange project related trainings for team members Primarily responsible for responding to the project audit findings Performing quality control checks for study related documents during and after the completion of the study Conduct the end of phase meetings to review lessons learned Project status update to Business Development/Management.

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 statistics department for the preparation of final Clinical study report, Mentoring junior CRA’s/CRC's for the study.

 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 department in Protocol writing/ICD preparation  Proof reading/ Quality check of documents prepared by the medical writing department(Note: Lotus Clinical Research was merged to Norwich Clinical Services, a subsidiary of Alvogen Pharmaceuticals Inc on November 2011)

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Advanced Post Graduate Diploma In Clinical Research

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