Experienced Clinical Research Professional

PRANEETH KUMAR CHOWDARY CHEBROLU

*** ***, *** * ******* Avenue, Chicago, IL, 60607.

Cell: 331-***-****

Email: *****************@*****.***

EDUCATION

Master of Science Clinical Research. Sep 2015 – May 2017

Rush University, Chicago, IL

Master’s Thesis Student at Rush graduate college in the clinical research program, with a good understanding of the following.

Clinical research methods

Clinical Trials

Biostatistics

Bio-Informatics

Ethics in Research

Epidemiology

GCP, ICH, and IRB policies

Clinical research literature

Data Management

Mentored Thesis – Rush Alzheimer’s Disease Center.

Doctor of Medicine M.D Sep 2005 – Mar 2011

Dr. NTR University of Health Sciences, Vijayawada, India

Extensive knowledge in Basic and Clinical medicine

Basic Medicine – Anatomy. Physiology, Pharmacology, Pathology, Microbiology

Clinical Medicine – Internal Medicine, Pediatrics, General Surgery, Obstetrics and Gynecology.

Internship- one year hands on clinical experience.

WORK EXPERIENCE

Oncology Clinical Research Associate Nov 2016 – May 2017

Robert H Lurie Comprehensive Cancer Center

Northwestern University, Chicago, Illinois.

Coordinate and drive clinical research studies and serve as research expert for Hematological based clinical trials

Collaborate with Clinicians, Regulatory, Data Management, Finance, Investigational Pharmacy and Research Lab to ensure proper trial management using CTMS.

Establishing and maintaining the TMF/ISF.

Prepared, handled, distributed, filed, and archived clinical documentation like General Correspondence, Protocol and Amendments, Ethics, Research and Development, Regulatory, Research team training, Patient documentation, Case report forms, SAEs and SUSARs, Monitoring and Audits, Lab certifications and training, Pharmacy and IMP documentation for TMF's

Prepare regulatory documents & reports, study budgets and assure compliance with all relevant IRB, HIPAA, DSMC and other regulatory agencies.

Randomizations of subjects, register study visits, maintain drug inventory and study supplies through IWRS.

Maintain program timeline for various components of the projects.

Evaluate and write research protocols and ICF in collaboration with the scientific review committee, medical writer and study investigator.

Collect, analyze, and validate research data through EDC systems like Medidata Rave.

Report program data and progress to study investigators and sponsors.

Initiate study startup activities and collaborate with process improvement and quality control committees.

Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes to ensure compliant clinical operation of studies.

Research budget analysis and subject reimbursements.

Performing Site Initiation and Close out visits. Assisting the CRA’s in monitoring visits.

Pharmacovigilance: Serious Adverse Event and SUSAR reporting and follow up in a timely manner.

Clinical projects:

Celgene - AG 221 AML trial -

Celgene - CC 90009

Astella - ASP 2215 - Phase 2a/2b trial

Cellerent CLT 008 Trial

Boehringer Ingelheim BI 1315 Trial

Clinical Research Associate Jun 2016 – Nov 2016

Apex Medical Research Inc.

Screening subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.

Randomizations of subjects, register study visits, maintain drug inventory and study supplies through IWRS.

Collects data as required by the protocol. Assures timely completion of Case Report Forms using EDC- OCRDC.

Establish and maintain the TMF/ISF.

Prepared, handled, distributed, filed, and archived clinical documentation like General Correspondence, Protocol and Amendments, Ethics, Research and Development, Regulatory, Research team training, Patient documentation, Case report forms, SAEs and SUSARs, Monitoring and Audits, Lab certifications and training, Pharmacy and IMP documentation for TMF's

Maintains effective and ongoing communication with sponsor, research participants and PI during the study.

Assists PI in preparation of any modifications to the scientific protocol in accordance with Federal regulations.

Performing Site Initiation and Close out visits. Assisting the CRA’s in monitoring visits.

Research projects: Phase III multicenter Pfizer O.A - Tanezumab Studies.

Junior Resident Doctor and Research Assistant May 2011 – Aug 2015

Kamineni Hospitals, Hyderabad, India.

Junior Resident in the departments of Nephrology and Emergency Medicine.

Clinical and diagnostic work up of Acute Cardio, Neuro, Nephrology patients

Preliminary medical and surgical treatment.

Patient Care : Hemodialysis and Kidney Transplantation

Research project: India's First ABO Incompatible Kidney Transplantation.

SKILLS

Clinical Trials, GCP, ICH, HIPPA, IRB Policies, Protocol Development, Clinical Literature Review, Bio Statistics, Bio Informatics, SPSS, Electronic Data Capture, Clinical Data Management, MS Office, Phlebotomy (4 Years), Clinical Research Database.

LANGUAGE SKILLS

Proficient in English, Hindi, Telugu.

VOLUNTEER EXPERIENCE

Department of Preventive Medicine,

Chalmeda Anand Rao Institute of Medical Sciences, Karimnagar, India.

Pulse polio Immunization program, crucial in eradication of polio from India.

Cervical cancer screening and health education in rural districts of Telangana.

Founder - Student blood bank and blood donation awareness camps.

Contact this candidate