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Clinical Research Associate Resume Sample, Experience : 7 years

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Name of the Candidate:[Private]
Name of the Post Applied:Clinical Research Associate
Job related skills / software:To communicate with different sections at CPB department with project related activities & Check Timelines.Compilation, review, preparation and submission of final study report in eCTD format which includes Bookmarking, Hypertext linking, and Creating TOC to PDF’s.
Sub Category:Clinical Research
Years of Experience:7 years
Salary Expected per Month(Rs):40,000 to 50,000
Highest Qualification attained:M.Sc. / MSC : Master of Science
Major / Specialization:Bio Technology
Email Id:[Private]
Are you looking for job now?:Yes
Can the recruiter contact you?:Yes
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Resume Format / CV Sample Template / Example / Model :


Niranjan N. Nikam
M.Sc. (Biotech.)
P.G. Diploma in Clinical Research & Regulatory Affairs

E-mail : niranjan.nikam02 AT gmail.com
Mobile No : 09975764804

Seeking a position to utilize my skills and abilities in the organization that offers knowledge growth while being resourceful, innovative, and flexible, to be proactive and develop creativity and initiative in a work, and to give best performance to the organization.

To prepare Final Study Reportin eCTD formatfor the FDA, EMEA & HEALTH CANADA submission as per ICH GCP, E3 Guidelines & Regulatory requirement the job responsibility mainly includes preparation & review of :

** Clinical Study Report Preparation (Pivotal and Pilot) & Compilation.
** Bio analytical Report Preparation (Pivotal and Pilot) & Compilation
** Statistical Report Preparation & (Pivotal and Pilot) Compilation.
** Method Validation and Addendum.
** BE Summary Report Preparation.
** SOP Preparation.

Wockhardt Limited, R & D (CPB Dept.) Aurangabad.
January 2012 to presentas SeniorOfficer.

Job profile :-
** Responsible of overall planning for the preparation, compilation and review of Final Study Report in eCTD format (Clinical, Bioanalytical, Statistical, BE Summary and MV/ Addendum report) as per ICH E3 guidelines, In-house SOPs and relevant regulatory requirements
** Data Uploading (Demographics, Clinical Laboratory Values, Vital Signs, Meal Distribution & Deviation of Sample Time Point)
** To check completeness & receive “Study Raw Data” from the Clinical Department & Preparation of relevant Clinical appendices, Reports and formats as per projects.
** To communicate with different sections at CPB department with project related activities & Check Timelines.
** Compilation, review, preparation and submission of final study report in eCTD format which includes Bookmarking, Hypertext linking, and Creating TOC to PDF’s.
** Quality control and quality assurance compliances.
** Dispatch of compiled final report to DRA & Resolving queries from DRA / Regulatory.
** Preparation of BE summary tables.
** Preparation and periodic review of SOP & Training to staff of Data Management Cell.

Strength :
** Excellent skills in e-CTD (both new and paper to e-CTD).
** Knowledge of USFDA, EMEA and Health Canada regulations.
** Willingness to be a continuous learner.

Caliber Point Business Solutions Ltd. Mumbai.
June 2010 to December 2011 as Service Delivery Executive

Job profile :-
** Verifying documents.
** Data uploading(Demographic details, Vital signs, Lab values etc.)
** Verifying patient treatment.
** Checking of raw data.
** Prescription Analysis.
** Discrepancy Management

Worked with Care Worldwide.
June 2009 to May 2010 asAssistant Clinical Research Associate

Job profile :-
** ICF Presentation and Obtaining ICF.
** Check-in and check-out of subjects into clinical facility.
** Supervision of blood sample collection during project.
** Dosing of Investigational product.
** Supervision of dosing of investigational product.
** Transfer of subjects samples from clinical research to the bioanalytical research.
** Preparation of SOPs.
** Preparation of clinical report.

** At CPB Dept, Wockhardt Ltd US-FDA audit (2013), (2016-Data Integrity), (2016)
** At CPB Dept, Wockhardt Ltd : DCGI (2013), (2014), (2016)
** At CPB Dept, Wockhardt Ltd : UK MHRA (2013)

** Post Graduate Diploma in Clinical Research & Regulatory Affairs 70.10% Year 2009 Nexus CRO.

** Master of Science {Specialization in Biotechnology} 58.50% Year 2008
** NACS Collage Wardha. Nagpur University Maharashtra.
** Bachelors of Science 73.10% Year 2006 Y.C. Collage of Science, Karad Shivaji University, Kolhapur, Maharashtra

** “Isolation, Extraction and purification LPS (Lipopolysaccharides) from S. typhi. And It’s use in Development of ELISA for Diagnosis of Typhoid Fever” in 2007-08.
** “Food values in some edible fresh water fishes from Krishna River” in 2005-2006.
** “Physicochemical and Microbiological aspects of Bread & Biscuits samples from Karad City” in 2004-2005.

** MS Office (MS- Word, MS- Power point, MS-Excel)
** MS CIT (Maharashtra State Certificate in Information Technology).
** Operating Systems : WINDOWS 98, 2000-03-10, XP and VISTA.
** Proper Knowledge of Internet Surfing & Downloading.

** Member of Corporate Cricket Team Mumbai for Pharma-CUP, Actively Participated & Organized in WPL 2012 & HFK-2012, 2013, 2014 , 2015 (As Captain), 2016 (As Captain).
** Actively Participated & Organized in Cultural Events (EUPHORIA), Painting Competition & Greeting Making Competition.
** International Conference On “Toxic Exposure Related Biomarker : Genomes and Health Effect”- In NEERI, Nagpur- 2007-08.
** Workshop on Solid Waste Management and its treatment. In Sevadal Lokmahavidyalay, Nagpur-2007-08.
** National Seminar on Biotechnology Approaches in Cleaner Environmental In Sevadal Lokmahavidyalay, Nagpur-2007-08.
** Certificate course in Laboratory Management and Food Analysis with ‘A’ Grade in 2004-2005.
** Completed Six months training in Medical Microbiology at Dr. Joshis Central Clinical Microbiology Lab. Navi Mumbai, 2009.
** Actively participate in National Service Scheme in 2005-2006. Worked as a Volunteer in NSS for 10 days camp at Banvadi (Karad)

Date of Birth : 02nd January 1986.
Marital Status : Married
Language known : English, Hindi, Marathi

I hereby declare that the above-mentioned information is correct up to my knowledge and I bear the responsibility for the correctness of the above-mentioned particulars.

Date :
Place : Aurangabad

Yours Sincerely,
Niranjan N. Nikam


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