Malathesha Ganachari, PhD

**** ******* ***** *** ***

Houston Texas 77030

832-***-****

email:acwc6m@r.postjobfree.com

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

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