1. ABHINAV SHUKLA
Email: - abhinavshkl146@gmail.com Mobile No. +91 9532610160
LinkedIn:- https://www.linkedin.com/home
C-8 Bhagirath colony Near Chomu House Circle
Jaipur Rajasthan, 302001
SUMMARY:-
Clinical Research professional with experience of handling different indication of clinical studies of
phase-III & phase-IV. M.Pharm in Pharmacology with Good Knowledge of ICH-GCP, Indian GCP, ICMR,
Schedule-Y Guidelines.
PROFESSIONAL EXPERIENCE:-
 Working as a Clinical Research Coordinator in On Site Services Incorporation (OSSINC) from
January 2016 to December 2016, one year.
 Currently working as Clinical Research Coordinator in Excel Lifesciences Pvt. Ltd. From
December 2016 to till Date.
ROLES AND RESPONSIBILITY :-
1.Name of Organization Excel Lifesciences Pvt. Ltd.
Duration December 2016 to Till Date
Designation Clinical Research Coordinator
Job Responsibility 1. Acting as a contact person for study monitor at site for any question
about study related activities.
2. Keeping a close association with Project Team to provide timely update
of Patient Recruitment, Patient Follow Up, and protocol related
activities.
3. Maintain effective communication system and ensure information flow
between site and project team members.
4. Provide regular and timely assistance to study monitor during
monitoring visits to ensure all the study related issues closed in timely
manner.
5. Assist Principal Investigator in the ICF process, screening & enrollment
of subjects in the study.
6. Coordination with the Investigator for Ethics Committee requirements
and preparation, submission of the essential documents.
7. SUSAR notification and SAE cross Notification to EC.
8. Transcription of data from source documents to paper CRF.
9. Completion of e-CRF (Oracle) for enrolled subjects.
10. Ensure to maintain the proper accountability of IP at the site.
11. Ensure proper filing of the study documents in the TMF (Trial Master
File) in their respective section.
12. Performed at the time of subject audio video Consulting.
13. Maintain and ensure timely update of the TMF in order to keep the TMF
ready for any upcoming Audit.
14. Perform data entry into EDC within timelines specified by Resolve Data
Clarification Forms in consultation with the investigator.
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2. 15. Expertise in handling “e-systems” of clinical trials like eCRF (Inform 4.6
Version), IWRS (ClinPhone & Cenduit).
THERAPEUTIC INDICATION:-
S.No Indication Phase Responsibility Indian /Global
1 Non Small Cell Lung Cancer III Primary CRC Indian
2 Malaria III Primary CRC Indian
3 Metastatic Breast Cancer (MBC) III Primary CRC Indian
4
Methicillin-Resistant Staphylococcus Aureus
(MRSA) Infection
III Primary CRC Indian
5 Acute Bacterial skin & Skin Structure Infection III Primary CRC Indian
6 Sexual Wellness IV Primary CRC
Indian
7 Vulvar Vaginal Atrophy III Primary CRC
US FDA SUBMITTED
8 Uterine Fibroids III Secondry CRC
Indian
9 Hepatitis-C IV Secondry CRC
Indian
10 Macular Edema With Non Infectious Uveitis III Primary CRC Global
ACADEMIC CREDENTIALS:-
TRAINING IN CLINICAL RESEARCH:-
 ICH-GCP Training in Mar-2016 by Physis Learning Institute.
 EDC training in June 2016 by Lambda Therapeutic Research Ltd.
 EDC training in October 2016 by Karmic Lifesciences.
 ICH-GCP Training in October 2016 by NIDA.
 IWRS Training in September by Biz-net.
 ICH-GCP Training in December by ELS India.
SEMINARS & WORKSHOP:-
• Participated in UGC sponsored National conference on current status and challenges in
pharmacy and health care held at C.S.J.M. University, Kanpur. (2010)
• Poster presented entitled “Harmonisation of pharmaceutical education in welfare of society.” At
UGC sponsored National conference on current status and challenges in pharmacy and health
care held at C.S.J.M. University, Kanpur. (2010).
• Won first prize in Quiz competition in ACADEMIA INDUSTRY INTERACTION PROGRAMME 2013
by H.R group of institutions Ghaziabad.
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Education Board/University Year
B.Pharm UPTU
2012
M.Pharm
(Pharmacology)
UPTU 2015
NIH Web Based
Training Course
(Protecting Human
Research
Participants)
NIH 2016

3. ACADEMIC PROJECT:-
(As part of Master of Pharmacy Curriculum)
Gastro protective effect of fruits of Annona squamosa in experimental animals. From
National Botanical Research Institute Lucknow under supervision of Dr. Ch. V Rao principal
scientist department of Pharmacognosy & Enthopharmacology NBRI Lucknow.
OTHER EXPERIENCES:-
 Proficiency in Microsoft Suite (MS Word, Excel, PPT).
 Instruments Handled: langendroff (microlabs), Plethysmometer(microlabs), IR
Actophotometer, Probe Sonicator, pH meter, UV-Spectrophotometer,IR Spectrophotometer
(shimadzu), Atomic absorption spectroscopy (shimadzu), .
 Methods Performed: Screening of various classes of drugs including Anti-Parkinsonism, Anti-
Cancer, Anti-inflammatory, Anti-ulcer, wound healing studies, Anti-diabetic, Diuretic, Anti-
Alzheimer’s.
LANGUAGE KNOWN:-
 English, Hindi, Bhojpuri & Awadhi
DECLARATION
I hereby declare that the above information furnished is true to the best of my knowledge and belief.
Place : Jaipur
Date : Abhinav Shukla
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