Clinical Research Associate

CURRICULUM VITAE

Deodhar Ushire

Cellular: +91-901*******

E-mail: **********@*****.***

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

Male, 28, Single, Mobile

CAREER OBJECTIVES:

To pursue a challenging and rewarding career in Clinical research where utilize my skills, abilities and can be demonstrated in an organization of high repute amidst a highly motivated and goal oriented team.

EDUCATIONAL QUALIFICATION:

Completed Professional Diploma in Clinical Research (PDCR) From Catalyst Clinical Services Pvt.Ltd. Delhi in Batch- FEBRUARY 2010.

Bachelors Degree in Pharmacy (B.Pharm) from NORTH MAHARASHTRA UNIVERSITY, Jalgaon in APRIL 2004 with HIGHER SECOND CLASS.

H.S.C from Pune board in FEBRUARY 2000 with SECOND CLASS.

S.S.C from Pune board in MARCH 1998 with FIRST CLASS.

CLINICAL RESEARCH KNOWLEDGE:

• Overview of Clinical Research & Phase of Clinical Research.

• Drug development and discovery.

• Clinical study and design phases.

• Study of documents CRF, ICF, IB and PROTOCOL.

• IRB, IEC, FDA, CRF, GMP, SOP and ICMR guidelines.

• Roles and Responsibilities of Clinical Trail Personnel.

• Clinical data management.

• CDA, Feasibility Questionnaire, SSV.

• ICH-GCP Guidelines, Schedule Y Guidelines.

• Source Data verification.

• Trial Master File.

CLINICAL TRIAL EXPERIENCE:

Working experience on following trials:

Indication Phase Role

Non Small Cell lung Cancer III CRC

Breast Cancer BE CRC

Small Cell Lung Cancer II CRC

Renal Cell Carcinoma II CRC

Relapsing Remitting Multiple Sclerosis III CRC

Benign prostate hyperplasia II CRC

PROFESSIONAL EXPERIENCE:

Currently working with XYLEM CLINICAL RESEARCH PVT.LTD. a Delhi based Site management organization, as ‘Clinical Research Coordinator’.

Roles and Responsibility:

• Maintain Confidentiality.

• Fill up CDA, Feasibility Questionnaire and IU.

• Assist Sponsors Site Selection Visit.

• Patient Recruitment and Retention.

• EC submission and Correspondence.

• IVRS and IWRS.

• Assist in process of administering Informed Consent.

• Ensure the fulfillment of all inclusion & exclusion criteria.

• Complete the CRF/eCRF within timelines.

• Follow up with site team for the completion of source documents.

• Compile and update trial master file.

• Manage the clinical trial material accountability.

• Assist in the screening & enrollment and Follow Up.

• Coordinate subject follow up visits to prevent lost to follow up & missed visits.

• Site Management as per the specific needs of Client & Protocol.

• Safety - Coordinate SAE reporting on time.

• Coordinate Monitoring & Audit visits.

• Compilation of study related documents.

• Responsible for the clinical supplies and non-clinical supplies accountability, distribution & Logistic.

• Site Management as per the specific need of Client and Protocol.

• Acting as a primary point of contact between the Principal Investigator, Site and Sponsor.

Pharmacist Responsibility:

• Dispensing of drugs to patients.

• Drug accountability and dispensing of all investigational products (IP) and concomitant medicines in clinical trials

• Receiving and checking the consignments of drugs/IMP for its appropriateness with respect to temperature during transport any breakage etc. Same should be acknowledged to sponsor via email/fax.

• Maintaining all IP related logs (dispensing log, randomization log, label log etc.).

• Storage of drugs as per temperature requirement

• Daily Temperature & Humidity recordings of Drug storage areas.

• Drug inventory maintenance.

Conference Participations:

Attended Investigator Meeting at Bangalore for BPH study (Phase III)

of MNC.

Worked as ‘Business Manager’ with Medybiz Pharma Pvt.Ltd. a group company of Reliance Health in Retail Pharma Business.

(May 2008-Apr 2011):

Roles and Responsibility:

• Branch Manager.

• Manage smoothly administrative and sales operation.

• Sales Plan and Promotion strategies.

• Liaison between Higher management and Branch.

• Managing total Branch team.

• Recruitment, Motivation and retention of team member.

• Review, monitor and analyze sales performance and competitor activities.

Worked as ‘Territory Manager’ with Cipla Ltd. In Lifecare division. ( Jan 2005- Apr 2008)

Roles and Responsibility:

• Medical Representative.

• Achieve sales Targets.

• Visiting Doctors, Institutions and Nursing Homes

• Meeting Distributors and chemist shop.

• Creative and resourceful sales and promotion strategies.

• Extensive travelling.

• Built relation and Repo with prime customers i.e. Doctors

• Review, monitor and analyze sales performance and competitor activities.

STRENGTHS:

• Able to work under optimal supervision.

• Excellent organization, Planning and problem solving abilities.

• Self confidant, hard working and enthusiastic.

• Establish interpersonal and communication skills.

REFFERENCES:

Dr. Minish Jain

Medical Oncologist

Ruby Hall clinic

Dr.Rakesh Neve

Consulting Onco-Surgeon

Nandadeep Multispeciality Hospital

Dr.Shriram Inamdar

Director Operations-

Xylem Clinical Research Pvt.Ltd Ms.Shweta Shende

Associate Operations-

Xylem Clinical Research Pvt.Ltd

Mr.Prashant Shinde

Senior Clinical Research Associate

PPD Mr.Sandeep Bhargav

Senior Clinical Research Associate

Lupin

PERSONAL INFORMATION:

Name : Deodhar Chintaman Ushire

Date of Birth : 04-04-1983

Gender : Male

Permanent Address : Siddharth Complex,flat no 5,Tapkir nagar,

Near Jagdale hospital,Kalewadi,Pimpri,Pune-411017.

Mobile : 901*******

Email ID : **********@*****.***, ***********@**********.***

Nationality : Indian

Languages known : English,Marathi,Hindi

Marital Status : Single.

Hobbies : Travelling, Reading , Swimming

And listening music.

I hereby affirm and state that the herewith-enclosed details are true to the best of my knowledge and my sincere efforts in keeping up the standards of your esteemed concern.

Date: Deodhar C Ushire.

Place: Signature:

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