Clinical Research Training

KAUSHALENDRA KUMAR

Nidhi Hospital, Shreekunj,

Stadium Commerce College Road,

Navrangpura, Ahmedabad (Gujarat) - 380009

**************@*****.***

Cell+91-830*******; +91-972*******

CarEer Objective

To achieve challenging and meaningful position to utilize my skills as

clinical research professional for the development of organization as

well as to explore my theoretical & practical knowledge.

WORKING EXPERIENCE

. November 2011- Till Date

. Name of the Organization : I5 Clinical Research Pvt. Ltd.

. Position Held : Clinical Research Coordinator

. Department : Clinical Operation.

. Role :

. Identify new sites, PIs and conduct the detailed protocol specific

feasibility.

. IRB Submission & Approval

. Regulatory document collection.

. Site Master File (SMF) set up.

. Conduct study according to International Conference of Harmonization

(ICH) E6 and Indian Good Clinical Practice (GCP) regulations.

. Assisting Principal Investigator in administering the Informed Consent

Form process.

. Preparation for Pre site selection visit (PSSV), Site Selection Visit

(SSV), and Site Initiation Visit.

. Ensure protocol adherence and compliance.

. Pre-screening, screening, enrolling & recruiting patients.

. Creating and Preparing Source Documents and their templates.

. Coordinate and schedule subject's regular follow-up visits and

procedures, preventing lost to follow-up & missed visits. Maintaining

regular contact with patients telephonically.

. Manage Clinical Trial Materials (CTM), accountability, distribution &

logistics at site.

. Co-ordinate all site specific queries-medical, administrative and

others.

. Maintain and update Site Master File, site binders and relevant files.

. Filling the CRF & eCRF and resolving all data queries in time on Data

Clarification Forms (DCFs).

. Reporting and coordinating all Adverse Events & SAE according to their

timelines.

. Filling up and maintaining trial related logs like source documentation,

drug dispensing logs, subject logs, Investigational Product Logs,

temperature logs. Maintaining Calibration records.

. Preparing Site for Monitoring & Audit visits, Coordinate close out visit

& Archival at site.

. Accurate and complete documentation of relevant EC documents.

. Communicating all protocol-related issues problems to the appropriate

management staff.

. To document protocol deviations as appropriate and communicate any

impacting subject safety to the Ethics Committee.

. Coordinate Central Lab logistics & sample flow, Review Lab data &

Communicate abnormal values to the primary care provider (if appropriate)

& Investigator.

. Co-ordinate Subject reimbursements.

. Performing all the above activities in strict adherence to the ICH-GCP

guidelines, Schedule Y & regulatory requirements.

. Participating in business development efforts to assist I 5 Clinical

Research Pvt. Ltd. identify business that entails the implementation of

clinical trials in India.

. Screening Patient Database.

. Coordinate and collection of lab reports according to GCLP.

. Assisted for Regulatory & Ethics Committee Submissions.

. Communication with the Ethics Committee and Sponsor/CRO on behalf of

Investigator.

. Safety reporting to Sponsor and Ethics Committee.

. September 2012- Mar 2013

. Name of the Organization : SAMA NGO.

. Position Held : Consultant

. Role :

. To take Interviews of those patients who once enrolled in the Clinical

Research as a Participants.

Training EXPERIENCE

. February 2011- September 2011

. Name of the Organization : Ranbaxy (Clinical Pharmacology Unit,

Delhi)

. Position Held : Clinical Research Coordinator.

. Department : Clinical Pharmacology Unit.

. Role :

. Presented IB, Protocol and ICF to the IRB before the Study Initiation.

. Subject Recruitment, Prescreening, Screening, Consent process as per the

protocol.

. Maintaining Source documents and Trial Master File.

. Data entry into the CRF and Query resolution.

. March 2010 - May 2010

. Name of the Organization : Max HealthCare Hospital (Saket,

Delhi)

. Worked as Trainee CRC in Cardiovascular Trial.

. May 2010 - June 2010

. Name of the Organization : Max Neeman International

(Delhi)

. Worked as a Trainee CTA.

Indication of Trial Clinical Phase of Role in Trial Year in which

Trial (I-IV) trial was

conducted

Chronic Kidney Phase III Clinical Research 2012- Till Date

Disease Coordinator

Hepatitis C Phase III Clinical Research 2012- Till Date

Coordinator

Influenza Phase II Clinical Research 2011-2012

Coordinator

Cervical Cancer Observational Clinical Research 2012-2012

Study Coordinator

Rheumatoid Arthritis Phase III Clinical Research 2011-2012

Coordinator

Antihypertensive BA/BE Trainee CRC 2010-2011

Previous Participation in Clinical Trial

PROJECTS UNDERTAKEN

. Successfully Completed Project in Ranbaxy, Project Title: Evaluation of

Percentage of Screening Failure with respect to area subjects belong to

(From March 2011 to August 2011 at Ranbaxy CPU Majeedia, Delhi).

. Bioavailability/Bioequivalence Protocol Designing On Candesartan Drug

during Training in Ranbaxy Research Laboratories.

. Coordination Report And IRB Report Writing during Training In Ranbaxy

Research Laboratories.

TRAININGS ATTENDED

. Ranbaxy Research Laboratories in Clinical Pharmacology Unit (8 weeks).

. MAX Healthcare (Saket, New Delhi) in Regulatory Affairs And Clinical

Operations (8 Weeks).

. MAX Neeman CRO. In Regulatory Affairs, Clinical Operations and Data

Management (15 Days).

. Attended Institutional Review Board Meetings at Max HealthCare Saket

(New Delhi).

. Attended Institutional Review Board Meetings at Jamia Hamdard

Institutional Review Board.

SUMMARY OF SKILLS

. Self-motivated, hard working & goal-oriented, with a high degree of

flexibility, creativity, commitment & optimism, determined to carve a

successful and satisfying career in Clinical Research.

. Enriched with the ability to learn new concepts & technology within a

short span of time.

. Good communication skills, verbal as well as written coupled with good

presentation skills.

ACADEMIC PROFILE

Academic Qualification University/Board Percentage

M.Sc. (Clinical Research) Jamia Hamdard (Delhi) 70%

B.Sc. (Biotech) CCSU (Meerut, U.P.) 66%

I.Sc. B.I.E.C. (Bihar) 61%

Matriculation B.S.E.B 47

ADDITIONAL SKILLS.

. Detailed Understanding of ICH GCP, Indian-GCP, Schedule Y, ICH CSR (E3)

and ICH (M4)

. Knowledge of BA/BE guidelines- CDSCO, EMEA, FDA, ANVISA.

. Languages Known: Hindi and English

. 5 Years Teaching Experience (Science and English) in Delhi and Surat.

. Computer Skills: MS Office and Internet Surfing.

. Successfully completed the online GCP exam of certification by Quintiles.

. Successfully completed the Inform 4.6 CRC- Modules Certification through

the online learning method administered by Oracle.

eXTRA CURRICULAR ACTIVITIES.

. Attended two Days Training Workshop on 'How to Coordinate Clinical

Trials, Practical Aspects' in Ahmedabad, from 28-29 January

2012.

. Attended two Days National Pharma Summit- 2010 in Jamia Hamdard,

Delhi.

. Attended 5th QCI Conference on Leveraging Quality for good

Governance.

. Attended XVII Annual Symposium of Ranbaxy Science Foundation.

. Participated in Various University Oriented Programme.

. Winner in District level General Knowledge Competition Examination.

PERSONAL DETAILS

. Permanent Address: P.H.E.D. Colony. Naya Bazar, Saharsa, BIHAR

. Date of Birth: 9th August 1981.

. Father's Name: SHRI BAIDYANATH JHA

. Gender: Male

. Marital status: Single

. Hobbies: Listening to Songs and Exploring New Places

. Strengths: Responsible, Honest, Keen

Learner and Team Player

Declaration

I hereby declare that above mentioned particulars are true to the best of

my knowledge and belief.

Place: Ahmedabad

(Kaushalendra)

Date:

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