US trained Board Eligible Neurologist, 10 years experience as a CRA

CURRICULUM VITAE

NAME Jagdeep Bhuta, M. D., MBA

DEPARTMENT Clinical Research Monitoring

LOCATION Round Rock, TX, USA

Home: 512-***-****

Cell: 512-***-****

e-mail: ********@*****.***

EDUCATION

2000 Masters of Business Administration

University of St. Thomas

1992 Neurology –Board Eligible in USA, completed one year Internship, three years of Neurology residency and one year of fellowship in Clinical Neurophysiology (EEG, EMG) at University of Minnesota in Minneapolis, MN.

!982 ECFMG examination passed in Jan 1982. ECFMG certificate issued Jan 1985

1982 M.B. B. S., (Bachelor of Medicine and Bachelor of Surgery)

University of Mumbai

Mumbai, India

PROFESSIONAL EXPERIENCE

9/2011 to Present Nexus Oncology

Senior Clinical Research Associate

• To conduct feasibility surveys and prescreened telephone surveys of clinical sites.

• To conduct Pre-study, Initiation, interim monitoring, and close-out visits,

• To attend Investigator meeting

• Monitor CRFs, and source documents, ensuring accuracy of data and that 100% of CRF data are substantiated by available source documents for the subject.

• To ensure that integrity of study and safety of subjects remained uncompromised during study.

• To ensure that sites are strictly adhering to protocol and conducting the study in accordance with the protocol as well as ICH/GCP guideline.

• To ensure that sites submit SAEs in a timely manner.

• To conduct the drug accountability, accounting for returned IP, and returns IP to sponsor.

• To review regulatory binder and Investigator’s file. Generates listings, ensuring that queries are resolved

• To ensure that sites submit and obtain approval for any amendments to the protocol, ICFs or Investigator Brochure

• To generates listings, ensuring that queries are resolved and promptly returned to sponsor. Ensures that sites submit and obtain approval for any amendments to the protocol, ICFs or Investigator Brochure.

3/2008 to 5/2011 Senior Clinical Research Associate

i3 Research

Cary, NC, USA

• Act as a Liaison between the site and the SAE coordinator

• Perform routine site visits, including pre-study, initiation, interim, and closeout visits. Visits to include monitoring of proper informed consent procedures, compliance with protocol, GCP/ICH Guidelines and other applicable regulatory requirements and assurance of good site performance. This is accomplished by detailed review of subject records, essential documents, investigational product disposition and accountability, site personnel and procedures.

• Manage assigned sites by regular contacts to ensure site compliance, adequate enrollment, and understanding of study requirements.

• Report to i3 Research project team, client, and site personnel any findings noted at monitoring visits. This is accomplished by completion of monitoring reports and follow-up letters within the project-

specific timelines. Significant issues noted must be reported to appropriate personnel immediately.

• Maintain eClinical or alternative project tracking system of subject and site information.

• Serve as back up for Regional Manager, Regional Clinical Monitoring Group when required.

• Provide training for colleagues on clinical, regulatory, administrative, and company procedures and processes.

• Participate in feasibility studies.

• Assist with company’s quality control initiative.

• Present study materials at Investigator/study launch meetings when required.

• Support project management team with assessment of workload and site assignments within the project team.

• Assist project management team with review of monitoring reports and study documents when required.

• Participate in the interview process of potential candidates when required.

• Participate in company-required training programs.

• Perform necessary administrative functions (e.g., tracking of expense reports, time and attendance).

• Maintain home office (e.g., procurement of office supplies, submission of documents).

• Perform other duties as assigned.

2006 to 2008 Senior Clinical Research Associate Kendle International Inc

Cincinnati, OH, USA

• Conducted feasibility surveys and prescreened telephone surveys of clinical sites.

• Conducted Pre-study, Initiation, interim monitoring, and close-out visits,

• Attended Investigator meeting

• Monitored CRFs, and source documents, ensuring accuracy of data and that 100% of CRF data are substantiated by available source documents for the subject.

• Ensured that integrity of study and safety of subjects remained uncompromised during study.

• Ensured that sites are strictly adhering to protocol and conducting the study in accordance with the protocol as well as ICH/GCP guideline.

• Ensured that sites submit SAEs in a timely manner.

• Conducted drug accountability, accounting for returned IP, and returns IP to sponsor.

• Audited regulatory binder and Investigator’s file. Generates listings, ensuring that queries are resolved and promptly returned to sponsor.

• Ensured that sites submit and obtain approval for any amendments to the protocol, ICFs or Investigator Brochure.

• Generates listings, ensuring that queries are resolved and promptly returned to sponsor. Ensures that sites submit and obtain approval for any amendments to the protocol, ICFs or Investigator Brochure

2001 to 2006 Senior Clinical Research Associate

PPD Austin, TX, USA

• Conducted feasibility surveys and prescreened telephone surveys of clinical sites.

• Conducted Pre-study, Initiation, interim monitoring, and close-out visits,

• Attended Investigator meeting

• Monitored CRFs, and source documents, ensuring accuracy of data and that 100% of CRF data are substantiated by available source documents for the subject.

• Ensured that integrity of study and safety of subjects remained uncompromised during study.

• Ensured that sites are strictly adhering to protocol and conducting the study in accordance with the protocol as well as ICH/GCP guideline.

• Ensured that sites submit SAEs in a timely manner.

• Conducted drug accountability, accounting for returned IP, and returns IP to sponsor.

• Audited regulatory binder and Investigator’s file. Generates listings, ensuring that queries are resolved

• Ensured that sites submit and obtain approval for any amendments to the protocol, ICFs or Investigator Brochure

• Generates listings, ensuring that queries are resolved and promptly returned to sponsor. Ensures that sites submit and obtain approval for any amendments to the protocol, ICFs or Investigator Brochure.

1998 to 2001 Senior Clinical Research Coordinator

Regions Hospital, Department of Neurology

St. Paul, MN

• Negotiated and finalized the budget and

Contract with the sponsor

• Attend the Investigators’ meeting with the PI

• Submitted the initial application to IRB to get

• the approval of the Protocol, Investigator

• Brochure, ICF

• Submitted the essential regulatory documents

• to the IRB

• Identified the potential subjects and

• Prescreened the subjects

• Scheduled the appointments for the subjects

• Pursued the execution of the Informed Consent

• (ICF)

• Conduct the procedures for screening and

enrollment and completed the source documents

• Collected, processed , stored or shipped the

Biological Samples

• Received, transferred, mixed, dispensed and

stored the Investigational Products (IP)

• Maintained the accountability of the IP

• Entered the data in CRFs (paper or electronic)

form the source documents

• Resolved the deficiencies, discrepancies or

any other issues identified by a monitor during

the monitoring visit

• Identified the Serious Adverse Events (SAEs)

and promptly reported it to the sponsor and

IRB in timely manner

• Resolved the queries generated by central lab

or data management center for the sponsor or

monitor or queries generated by Electronic

Data Capture system (EDC)

• Tracked the payment form the sponsor and

maintained the financial accounting

• Obtained the approval of the advertisements

(Brochures, Pamphlets, Scripts for the radio or

T. V. ads, and Dear Dr. letters etc.) from the sponsor and IRB

ADVANCED TRAINING AND CERTIFICATIONS

1991 to 1992 A fellowship in Clinical Neuro-electrophysiology (Nerve Conduction Velocity & Electromyograms, Nerve Action Potentials and Electroencephalogram) at University of Minnesota hospitals, Minneapolis, MN, USA

1987 to 1991 Internship and Residency in Neurology at University of Minnesota affiliated hospitals

Minneapolis, MN, USA

PROFESSIONAL MEMBERSHIPS

1999 Association of Clinical Research Professionals &

1987- 1989 Member of American Medical Association

FOREIGN LANGUAGES

Gujrati Speak and Read

Hindi Speak and Read

Marathi Speak and Read

SUMMARY OF THERAPEUTIC EXPERIENCE

Diabetes, Neurology, Oncology & Psychiatry

SUMMARY OF PHASE EXPERIENCE

Phase II Number of studies: 10

Phase III Number of studies: 12

Phase IV Number of studies: 10

AUTHENTICATION

The information in this document is accurate and complete to the best of my knowledge.

Signature Date

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