Data Entry Clinical Research
Resume:
Malathesha Ganachari, PhD
Houston Texas 77030
email:**************@*****.***
OBJECTIVE
To secure employment as a Clinical Research Associate and thereby support clinical trials and the drug development process.
Job responsibilities and Work history
•Accurate and timely data entry in electronic case reports forms (eCRFs) and paper case report forms (CRFs).
•Worked closely with study sponsor monitor and resolve data queries that may be generated.
•Maintain all paper source documents and electronic medical records. Ensure they are available for monitors during the monitoring visit.
•Help study monitor schedule and conduct pre-study site visit (PSSV), site initiation visit (SIV), interim monitoring visit (IMV) and close out visit (COV).
•Preparation of regulatory IRB documents for initiation of new clinical studies, including review of protocol, ICF and submission to the local IRB.
•Maintaining Investigator Study File (ISF), Financial Disclosure, CVs and Medical Licenses and training documentation for all study personnel.
•Maintenance of regulatory paperwork and maintain regulatory binders in accordance with sponsor specification, and institutional standards.
•Preparation of continuing reviews, and safety reports to local IRB review.
•Preparation of budget for clinical studies.
•Attend Investigators meeting and sponsor calls.
•Maintenance of study binders on study correspondence and patient folders/records.
•Submission of shipment of biological specimens/samples for rapid reviews and banking.
•Maintenance of clinical samples repository.
Clinical study program coordinator I ( HIV- TB co-infection Study)
Department of Infectious Disease Research, Indian Institute of Science
Bangalore 560056 India
January 2014 to November 2015
Post doctoral Research Associate (Population based Case -Control study –TB disease)
The Methodist Hospital Research Institute, Bertner Ave Houston TX 77030, UNITED STATES
May 2007 – Oct 2013
Post-doctoral Research Associate ( Lung Cancer Research)
The University of Texas Health Science Center, Tyler Texas, UNITED STATES
Nov 2003- April 2007
EDUCATION
Doctorate, PhD (Zoology), June 2002
Bangalore University . Bangalore, India
PROTOCOL THERAPEUTIC EXPERIENCE
HIV –TB coinfection
Tuberculosis
ACCOMPLISHMENTS
Co-ordinate and help in achieving several successful data cuts.
Attentive to details
Work independently as well with minimal supervision
Excellent time management with multi-tasking skills
COMPUTER SYSTEM EXPERIENCE
MS OFFICE: Words, Excel & PowerPoint, MS-Outlook, MEDIDATA, SAS
TRAININGS
GCP training
HIPAA Training
CITI training
Credentialing to conduct research on animals and human subjects
REFERENCES
Available on Request
Contact this candidate