WORK o Duties involved: · Executing and supervising 10-12

WORK EXPERIENCE

 

Ø  Clinical Translational Research Coordinator-II, Department of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, TN

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o   Dec 2016- present

o   Duties involved:

·         Executing and supervising 10-12 clinical research studies at a time, from recruitment of subjects to end of study

·         Recruiting and maintaining randomized patients for each clinical trial, exceeding the enrollment goals, registering as high enrolling site. Oversee adherence to study protocol for clinical patient evaluations, treatment administration, and collection, processing, and shipping of biological specimens

·         Coordinate and conduct patient care visits and assure all procedures are conducted in compliance with the protocol  

·         Meet with study sponsors and CRO representatives for site qualification visits, including tour of various areas of the facility

·         Maintaining recruitment database and ensuring accuracy of patient charts and protocol documentation through IRB Regulatory,  Electronic Data Capture (EDC) and Interactive Web Response System (IVRS/IWRS)

·         Responsible for formation and completion of all study documentation forms, including source documentation, case report forms and other study specific document

·         Complete CDAs, site feasibility questionnaires, schedule site visits; complete regulatory submissions for trials, ongoing submissions

·         Complete study trial visits (i.e. screening visits, treatment visits, follow up visits, unscheduled visits, etc.)  

·         Understand thoroughly all assigned studies through reading protocols, attending investigator meetings and start-up meetings, and coordinating with Principal Investigator and other staff as appropriate 

·         First point of contact for data query generation and resolutions

·         Performing various procedures on patients such as EKG, EEG, assisting phlebotomy blood sampling, urinalysis, biomarker samples, and assisting IV placement. Coordinating schedules of patients, therapists, monitors and doctors while adhering to strict protocol guidelines 

·         Distributing, maintaining, and logging investigational product for treatment of patients. 

·         Inputting, quality control, and certifying all source data are placed in sponsor’s various electronic databases 

·         Responsible for assuring, arranging and providing appropriate services such as either on-site facility or by contracting with compatible external vendors who could provide their services for protocol specific diagnostic lab tests, diagnostic imaging after reviewing clinical trial requirements for the clinical studies

·         Oversight strictly as a coordinator for all the studies. Determine subjects as per protocol meet all of the inclusion criteria and none of the exclusionary criteria. Flag any erroneous randomization or other protocol violations to be reported immediately to sponsor and IRB. Review informed consents and assure if they are done as per site SOP and no violation of patients right occurred, collect and review clinical trials data, conduct & train staff any protocol specific assessments, assuring all data is entered into the EDC as well as necessary in the practice’s electronic medical records system

·         Act as a primary liaison between Principal Investigator, Sub-Investigator, Pharmaceutical/CRO/Sponsor pharmaceutical companies to regulate, coordinate clinical research protocols and resolving any pertaining queries

·         Serve as the lead Clinical Research Coordinator in conducting clinical research trials for multiple medical specialties while strictly following the ICH/GCP/FDA guidelines. 

·         Reviews and discuss study progress with study staff for clinical studies and address any challenges or barriers staff may have or experiencing in execution of clinical trials or in any day to day clinical operations.

·          Develops and executes plan for installing and validating new and or any upgraded data entry, Electronic Medical record software(s).

·         Effectively met deadlines and consistently exceeded expectation for timely data collection and submission.

·         Assist in creating study budgets and lab supplies

·         Complete all IRB submissions including applications, consent documents, ancillary applications, amendments, serious adverse event submissions, continuing reviews, and close-outs.

·         Create and maintain regulatory binders and maintain GCP for the site

·         Train the study staff and new coordinators on studies

·         Screened subjects from the daily clinic schedule and confirm eligibility of potential study subjects and randomize via IVRS or IWRS

·         Work with study monitors to ensure data quality and regulatory document compliance from study initialization to closeout

·         Assist in entering patient data in PortCF

 

Ø  Clinical Translational Research Coordinator-I, Department of Nephrology and Hypertension

Vanderbilt University Medical Center, Nashville, TN

o   July 2015- Dec 2016

o   Duties involved:

·         Initiate, manage and monitor various clinical research projects and provide projects specific administrative support

·         Assisted in performing various vascular studies: Pulse wave velocity, Flow Mediated Diameter

·         Actively participated in clamp studies

·         Organized and maintained all study documentation including source documentation, case report form, study and regulatory binders and patient binders

·         Scheduled study visits and necessary testing including procuring blood and urine samples

·         Prepared and processed all documentation through the Institutional Review Board (IRB), including submissions, continuing reviews, amendments and adverse event reporting

·         Enrolled approximately 50 study participants from start study visit till completion of all research activities

·         Provided constant research and administrative support to research department

·         Engaged actively in research meeting and discussion about various research projects

·         Provide training to new staff and associates

 

Ø  Clinical Pharmacist Intern, Department of General Medicine, Psychiatry, Ob/Gyn, and Pediatrics

KIMS Hospital and Research Center

Bangalore, INDIA

o   November 2010 to October 2011

o   Duties involved:

§  Drug therapy monitoring (medication chart review, clinical review, pharmacist interventions) on inpatient service with active participation on morning team rounds.

§  Adverse drug reaction management.

§  Patient counseling on discharge medications.

§  Drug utilization evaluation (DUE) and review (DUR)

 

Ø  Team member, Department of Tablet and Capsule formation

SYMCOM Healthcare Limited

Uttar Pradesh, INDIA

o   2007

o   Duties involved:

·         Evaluation of raw materials and helped with development and processing of medication tablet and capsules.

 

EDUCATION

 

                Graduate School              Doctor of Pharmacy (Pharm. D)                                                 November 2011

                                                                Distinction (GPA 4.0)

                                                                Rajiv Gandhi University of Health Sciences

                                                                Bangalore, India

 

                                                                Biotechnology Technician (Industrial Microbiology)       December 2013

                                                                Centennial College (School of Engineering)

                                                                Toronto, ON (Canada)

 

                Undergraduate                 Bachelor of Pharmacy (B. Pharm)                                             November 2007

                                                                Distinction (GPA 3.86)

                                                                Rajiv Gandhi University of Health Sciences

                                                                Bangalore, India

 

Ø  Credentials were evaluated by Educational Credential Evaluators (ECE) and confer U. S. equivalency of Bachelor’s degree and Doctor of Pharmacy degree (Pharm. D).

 

                                                                                                                                         

CERTIFICATIONS

 

·         Human Research Group: Biomedical Research Investigators and Key Personnel

Issued by the Collaborative Institution Training Initiative (CITI)

·         Medidata RAVE Certified Clinical Research Coordinator

·         CF Overview for Researchers Certification

·         Good Clinical Practices (GCP) Issued by NIDA Clinical Coordinating Center

·         Centralized Spirometry Certified

·         Sweat Test Certified

·         IATA Certified

 

TRAININGS

 

·         GCP and Investigator Responsibilities

·         Global Safety SAE Reporting

·         CF Medical Coding

·         Bracket IWRS System Overview

 

 

Educational Conferences/ Meeting

·         Attended TDN Spring meeting, Nashville 2017

·         Vertex US and ROW Investigator Meeting for Protocol VX16-659-101, Boston 2017

·         Attended NACFC, Indianapolis 2017

·         Vertex NextGen Phase III Investigator Meeting, Dallas 2018

·         TDN Spring Meeting, Philadelphia 2018

 

 

AWARD

     Recipient of NEPHRON Award, 2016; Nephrology and Hypertension Division, Vanderbilt University Medical Center, Nashville, TN.

 

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