1. Vimaljeet Kaur
House no.360,
W-3, Vaishali
First floor, sec-1,
GHAZIABAD-201012
 +91-8860839921/9643170465
Email ID: kaurvimal2@gmail.com
RESUME TITLE
A result oriented professional with 2 years 7months experience in Clinical Research
field
as a CRA and Regulatory Affairs in a pharmaceutical company.
Total nearly 155 monitoring experience includes ( 50 Site Initiation Visits,60 Interim
monitoring visits ,45 close out visits).
Career Objective: To gain the knowledge while working in a professional environment
and achieve my goals with combination of honesty, sincerity and hard work to pursue a
challenging career and be a part of a progressive organization that gives scope to
enhance my knowledge and skills.
Additional Excellence in: Good communication skills, Presentation, Team Management,
Professional Approach in Work, Disciplined
Computer Proficiency -
 Basic Knowledge: MS-Office, Windows – 98, 2000, 2003, XP and Windows Vista .
Operational proficiency -
 Well aware of the regulations of all countries: US FDA, MHRA, CDSCO, ICH-GCP,
SCHEDULE Y, Y-1.
Academic Qualification -
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2.  Diploma in Clinical Research Management from Indian Clinical Research Institute
(ICRI) Delhi.
 PGDACR (Post Graduate Diploma in Advance Clinical Research) from ICRI.
 BSc. In Biotechnology from Chaudhary Charan Singh University , Meerut.
 12th
from Holy Child School from CBSC Board.
 10th
from Nancy Convent School Nainital CBSC Board.
Major projects completed -
 Phase III, Multicentric Clinical Trial of Rabies Vaccine to evaluate Safety and
Immunogenicity (Sure RabTM
with Vero RabTM
).
 Phase I unicentric Trial of typhoid vaccine Vi polysaccharide with Vi conjugate
tetanus.
 Phase I, Open ,Unicentric Clinical Trial for evaluation of safety of Varicella
Vaccine ,Live (I.P) (OKA Strain) in adults .
 Multicentric , Phase II/III Clinical Trial for evaluation of safety and
immunogenicity of Live Varicella Vaccine ,(OKA Strain) versus reference vaccine
in Indian Children.
 At present working on Phase IV of Polio Tri-valent Vaccine.
 One paper published on chickenpox
Area of Interest
 Monitoring of the trials.
 Preparation of documents for conducting Clinical Trial according to GCP &
Schedule Y guidelines (CRF, Investigator Broucher, Subject Diary etc).
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3.  Ethical Committee and CTRI approval & registration.
 Presentation of protocol at IEC and NDAC.
 Writing the Protocols ,manuals ,Paper’s for publication.
Work experience-
 Working as a Clinical Research Associate in Bio-Med (P) Ltd. Vaccine
manufacturing Pharmaceutical Industry (working from Oct.2012 to till now).
WORK DONE –
 Two years 7 months experience in Monitoring of the trials, in Regulatory Affairs
with Writing .
 Monitoring of all the trials going on in our Clinical Centers MAMC ,ICH Kolkata,
GTB Hospital ,Ganga ram hospital.
 Handle all the regulatory work of the trials.
 Preparation and Maintenance of Clinical Trial Master File and Site Master File.
 Participate in Preparation and review of departmental SOPs.
 QC/QA audits of Phase I and Phase III Trials.
 Writing the material for publication.
 Audit of pre-exposure trial of Rabies Vaccine.
 Done the BE/BA Study.
 Prepare the Post Marketing Surveillance Protocol of Polio Vaccine.
 Prepare the reports of PMS studies.
 Given the presentation to DCGI office for the approval of the trial.
 Faced the DCGI Inspection.
 Amendments done according to new guidelines or suggested by EC of the clinical
center.
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4.  Assist medical monitor in preparation of Protocol ,Investigator Brochure,Diary
cards,CRF,Audio-Vedio and normal Inform Consent Documents,Clinical Study
Report.
 Regular basis meeting with the PIs and Co-investigators in all the sites.
 Well aware of CTRI approval and registration.
 At a time Handles 3, 4, clinical centers in which trials are going on.
 Performed Site Evaluation, Initiation, Monitoring and close out activities.
 At present working on Phase IV of Polio Tri-valent Vaccine.
 Writing Experience –
 Writing the material for publication and Paper published are:
1. Paper on Chickenpox for Phase I,II and III.
2. Paper on Rabies for Pre and Post exposure.
 Write the following protocols which are Approved by DCGI(Drug Controller
General of India) and study is completed:
 1. Protocol of Peda Typhoid (conjugate vaccine) .
2. Protocol of Chicken pox Trial.
3. Protocol of Rabies Trial.
4. Protocol of PMS Study of Polio Trivalent (study is going on).
 Writing the SOPs related to the trial.
 Preparing the Advertisements for the trials in local newspapers.
 Writing or Preparing the Reports for DCGI submission.
 Regulatory Affairs Experience –
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5.  Work done for the new product registration /endorsement of the product.
 Implemented QA systems and generated SOPs.
 Respond to the Queries received from the Competent Authorities.
 Deal with the Quality related questions and complaints.
 Liaising with the Regulatory Authorities.
 Maintained the database with regulatory submission and approval dates.
 Technical discussion with Regulatory Authority.
 Preparation of Form -10 (i.e.import Lic) and Form -40 (Product Reg. Application)
for the new products and renewals.
 Filling Serious Adverse Events notifications, Clinical Trial Application and
responses & reminder /follow up letters to govt. authorities.
 Participation in Subject Expert Committee (SEC) meetings.
 Responsible for updating new regulations implemented by govt.authorities.
 Responsible for technical discussion at Airport Authority for releasing the
consignments.
Personal Appraisal-
 Efficient Analytical skills-A Quick learner.
 Knowledge of self correspondence.
 Determination to complete the task on time and willingness to accept the
challenges.
 Ability to adopt different situations, peoples and environment.
 Ability to simplify complex task.
Achievements / Fellowships-
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6.  Qualified IIT entrance Masters Program in biotech.
 Merit position in Graduation.
 Qualified IAS Pre and Mains Exam 2013.
 Participated in International Conference on “Access to Healthcare” in ASSOCHAM
New Delhi.
Personal Information
Father’s Name : Miss.Vimaljeet kaur
Marital Status : Unmarried
Date of Birth : 30th
October, 1988
Nationality : Indian
Hobbies : Watching movies, writing short stories & reading
books.
Linguistic competencies : Hindi , English and Punjabi.
I hereby declare that the above mentioned information is true to the best of my
knowledge and belief.
(Vimaljeet kaur)
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7.  Qualified IIT entrance Masters Program in biotech.
 Merit position in Graduation.
 Qualified IAS Pre and Mains Exam 2013.
 Participated in International Conference on “Access to Healthcare” in ASSOCHAM
New Delhi.
Personal Information
Father’s Name : Miss.Vimaljeet kaur
Marital Status : Unmarried
Date of Birth : 30th
October, 1988
Nationality : Indian
Hobbies : Watching movies, writing short stories & reading
books.
Linguistic competencies : Hindi , English and Punjabi.
I hereby declare that the above mentioned information is true to the best of my
knowledge and belief.
(Vimaljeet kaur)
– Colour of knowledge empowers me to deliver –
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