vijeeta tadla

* Reconcile and maintain clinical site regulatory binders to ensure ICH GCP compliance * Lead coordinator for multiple studies (Phase II, III multi centered and pilot studies) PI and sponsor initiated * Executed pre-study visits, site initiation visits, monitoring visits and close-out visits * Data entry of electronic case report forms into sponsor data base (EDC), maintain Trial Master Files * Registration and updating the studies on ClinicalTrials.gov * Assist in financial budgeting and reporting * Regulatory report to local IRB, FDA and study sponsor as well as keep research files and regulatory binders for active studies and subjects * IRB submissions (Study start-up and closure, continuing review, A.E reporting and protocol deviations reporting) Also worked on safety reports, SAE * Compose Informed Consent Forms and extract relevant data from sponsor clinical study protocols for initial IRB submissions and study start-up

* Project manager for sponsor funded Limbal Stem cell transplant study, duties include: maintaining * lab certification through Harvard University committee on microbiological safety, regulatory * documentation and subject recruitment * Complete quarterly and yearly reporting to FDA and DOD for existing IND’s * Responsible for TMF management plan and quality and completeness of TMF for assigned * projects * Direct the activities of assigned project study staff * Ensure studies are conducted in compliance with GCP, relevant SOP’s and regulatory requirements

* Responsible for maintaining 30+ global investigator-initiated studies through all study phases across two disease states encompassing four products. * Oversee the review and approval process for all external research applications including scientific review committees, budget reviews, and contract negotiations to ensure global standards are met. * Manage and support timely delivery of investigational product and other study start-up activities globally.

* Clinical Study Coordinator at Department of Endocrinology, Boston University Medical Campus. * Perform chart review, conduct phone screens and collate information on trial eligibility of the subjects for physician investigators * Schedule and plan patient visits and maintain study documentation * Key contact for IRB preparations and submissions for current studies, respond to IRB queries, and prepare protocol amendments and submissions. Experience working with INSPIR II * Collect study participant’s medical records, organize and review medical records from EPIC (data mining)

Doctoral Thesis: “Studies on Chemo-enzymatic Synthesis of Novel Phospholipids and Their Biological Activity” Prepared and Analyzed Novel Phospholipids for Biological Activity using enzymatic approach Synthesized blood platelet activating factor and its PE analogue with varying alkyl chain lengths (tetradecyl, hexadecyl, octadecyl) using chemo-enzymatic approaches Developed novel chemical method for synthesizing PE-N-amino acid derivatives Conducted anti-bacterial and anti-fungal activity for various PE-N-amino acid derivatives Hydroxylated both egg and soy phosphatidylcholine (PC) using enzymatic approach Studied positional distribution of fatty acids and comparative study of emulsifying properties before and after incorporation of hydroxyl fatty acid (riconoleic acid) into egg and soy PC Incorporated saturated fatty acids like palmatic and stearic acid into egg and soy PC using enzymatic approach

Masters in Medicinal Chemistry

Bachelors in Chemistry with Microbiology and Botany

Relevant Coursework: Designing Clinical Research Studies, Regulatory and Compliance Issues, Seminar in Clinical Investigation, Good Clinical Practices in Clinical Research