RESUME

Chandrakant K Jadhav

Add: LIG-*st, Sector-3, Room no-L-8, Kalamboli.

Navi Mumbai; Tal-Panvel, Dist-Raigad-410218.

Maharashtra; Country: India.

Contact No: 970-***-**** / C/O-982*******.

Email: adc2up@r.postjobfree.com.

CAREER OBJECTIVE

A motivated, results-focused Clinical Research professional, seeking an opportunity to utilize career experience, skills, and education to contribute to employer objectives, profitability, and success with a company offering potential for challenge and growth.

ACADEMIC QUALIFICATIONS:-

CREDENTIALS

INSTITUTION

YEAR OF COMPLETION

CLASS

LLB

(Mumbai University)

2018

Second

MBA- Clinical Research

(Deemed University)

2012

Second

BSC (Chemistry)

(Mumbai University)

2009

Second

DMLT

ICPME Paramedical Institute.

2006

First

CMLT

(Maharashtra Board)

2005

First

HSC

(Maharashtra Board)

2004

First

SSC

SES School

2002

First

COMPUTER PROFICIENCY: -

MS-CIT Examination of Maharashtra Technical Board, First Class, 2002

PROFESSIONAL EXPERIENCE: Total Clinical Experience: 7+ yrs.

1)Lambda Therapeutic Research Ltd. Mumbai, India

Designation : Senior Clinical Research Associate.

Work Period : (24 August 2014 to till date)

Key Responsibilities – Clinical-QC (Quality and compliance)

Working on electronic data capture system e-CRF for review process.

Working on electronic system e-TMF for review process.

Online study activity check (Dosing, Posture criteria, sample collection, Meal, sample separation, Vital, Check-in-Check-out activity, subject eligibility criteria, AE reporting and documentation) to whether this activities conduct in compliance with protocol, Sop and applicable regulatory guideline.

To conduct retrospective audit of the data generated such as case report form, ICF, MSR etc. to check that the data is accurate, complete and verifiable.

To conduct QC system audit of clinical facility. Check logbook and calibration of instrument, vendor agreement etc.

Review study related documents, clinical updates, accountability of study controlled forms TMF, ICF and MSR.

Actively participate in Project activity (maintenance of posture and water restriction, meal verification, High fat break-fast and meal distribution, supervision.)

Handle inter departmental project related communication through proper channels.

Check and Submission project documents to QA department within time frame.

Resolving the queries and doubts of QA after QA audits.

Archiving and retrieving study related documents.

Any other responsibility as designated from time to time by the HOD/ Designate.

2) Company : Macleads Pharmaceutical Ltd, Mumbai.

Designation : Clinical Research Associate (CRA)

Work Period : May 2013 to Aug-2014.

Key Responsibilities:

Responsible for Maintenance of Project Master File & work as a Project co-coordinator

& responsible for accountability of study related documents

Recruitment, enrollment, screening, check in & check out procedure & handling

Volunteer database & online vol.information software (OVIS) activity.

Subject monitoring during study & Documentation, follow-up & post study activity of subject & Handling AE & its reporting to the PI.

Preparation of SOP, Protocol & ICF, and CRF, Clinical study Reports, Clinical summary report of study,

Pre dosing preparation & Dosing activity & Plasma Separation & storage.

Submission study related doc.to to IEC & take approval from IEC

Detailed review of CRF, ICF & Study related documents

Participate in company-required training programs, Coordinate with QA/QC, Organize

Inter dept. Meeting, SOP training to staff & liaise with pathology & X-ray dept for reporting Status of Volunteer & Subject.

Ensure standardize meals are provided to subject during project & record in CRF.

To assist during Audits, maintaining record of training file of dept. Compilation of data,

Archival documents, study file & clear QA/QC study related audit reports.

To organize sample dispatch to bio-analytical department / Sponsor.

3) Company : Drug monitoring research institute (DMRI) Rabale —Navi Mumbai.

Designation : Clinical Research Associate (CRA)

Work Period : March 2012 to April 2013

Key Responsibilities:

Responsible for Maintenance of Project Master File & work as a Project co-coordinator

& responsible for accountability of study related documents

Recruitment, enrollment, screening, check in & check out procedure & handling

VMS & OVI software for registration activity.

Subject monitoring during study, follow-up, Subject, & Handling AE & its reporting to the PI, IEC & Sponsor

Preparation of SOP, Protocol & ICD, and CRF, Clinical study Reports, Clinical summary report of study, Dosing activity & Plasma Separation & storage.

Submission study related doc. to IEC & take approval from IEC

Detailed review of CRF,ICF & Study related documents

Participate in company-required training programs, Coordinate with QA/QC, Organize

Inter dept.meeting, SOP training to staff & liaise with pathology & X-ray dept for reporting updates of Volunteer

Ensure standardize meals are provided to subject during project & record meals records in CRF.

To assist during Audits, maintaining record of training file of dept., compilation of data.

Archival documents & study file & clear QA study related audit reports.

To organize sample dispatch to bio-analytical department / Sponsor.

4) Company : Niramaya Hospital, Kharghar Navi Mumbai

Designation : Lab Executive.

Work Period : May 2009 to June 2010

Key Responsibilities:

Arranging appointments with doctors may include pre-arranged appointments.

Detail records of all contacts & Records (Marketing purpose)

Responsible for promoting & marketing services to GP & Nursing home, other hospitals, medical Centers (e.g. Lab investigation, x-ray, medical & hospital services) giving presentation to them about Niramaya services & what benefit to them.

EXTRA — CURRICULAR ACTIVITIES :( WORKSHOP):

Attended a workshop on Pharmacovigillance by Prof. Almas Sayyed (ICH-GCP certified trainer).

Attended a workshop on GCP by Dr.Shedbalkar (Pharma edge center Pvt. Ltd.) at DMRI. Also attended Seminar on ICH-GCP by Dr.Issac john (NHS foundation trust UK) & Dr.Charusheila (Director Connoisseur clinical research Ltd, India) at DMRI, Rabale.

Attended a workshop on clinical research monitoring by APAP association at Bharti Vidyapeeth.

Attended Training of Volunteer database management system software by Riyaz khan (Smart Identification).

Attended a workshop on GCP and GDP by Dr. Kiran Marthak Sir at Mumbai Lambda.

TRAINING PROGRAM:

SUMMER SCHOOL (UK): Attended one month summer training program at Middlesex Business School, of Middlesex University at London: -The Power of Marketing. This program provided an insight on social marketing, branding, health marketing and entrepreneurship.

EXTRA — CURRICULAR ACTIVITIES :( WORKSHOP):

Attended a workshop on Pharmacovigillance by Prof. Almas Sayyed (ICH-GCP certified trainer).

Attended a workshop on GCP by Dr.Shedbalkar (Pharma edge center Pvt. Ltd.) at DMRI.

Attended training on ICH-GCP by Dr.Issac john (NHS foundation trust UK) & Dr.Charusheila

(Director Connoisseur clinical research Ltd, India) at DMRI, Rabale.

Attended a workshop on clinical research monitoring by APAP association at Bharti Vidyapeeth.

Attended Training of Volunteer database management system software by Riyaz khan (Smart Identification)

AREA OF INTERESTS:

Cricket, Driving, Listening music.

PERSONAL MEMORANDA:

DATE OF BIRTH : - 08th May 1987.

NATIONALITY : - Indian.

LANGUAGES KNOWN : - English, Marathi and Hindi

MARRITAL STATUS : - Married

CURRENT SALARY : - 5.77 /Annual

Declaration

I hereby declare that the above written particulars are true to the best of my knowledge and belief.

Date :-

(CHANDRAKANT K JADHAV)

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