Resume CV : Clinical Research Associate CRA

[meghasfotedar]

Megha Fotedar

Objective :
To gain experience and provide best service and productivity by hard work and teamwork in a clinical research industry rendering competitive environment and challenging tasks so that I can excel in the field of clinical research and work for the betterment of my organisation.

Academic Qualification :
Qualification School/College Board/University Percentage Year of passing :
M.SC in clinical research Institute of Clinical research Cranfield University I Class 2009
PGDCRM Institute of Clinical research ICRI (India) I class 2008
Bsc inMicrobiology Karmaveer Bhau RaoPatil College. Mumbai University II Class 2007
H.S.C V.H.S J&k State Board I Class 2004
10th Army Public School CBSE I Class 2002

Experience :
- 10 months of experience in Clinical Research

1. worked as a Clinical research coordinator at Asian Heart Institute for 5 months.
Process : -
· Completing regulatory documents
· Developing study process , documents
· Retrospective studies of patients who have undergone :
· Bypass surgery
· Angioplasty
· Redo CABG
· Patients with low ejection fraction
· Patients with Atrial fibrillation
· Conducting an Institutional Review Board Meeting for reviewing and approving the documents regarding clinical trials.
· Completion of the case record Forms and recruiting patients for clinical trial.
· Conducting all research trials according to the ICH GCP guideline.
· Having great proficiency in e-crf and data analysis.
· Reporting any Serious Adverse Event to the sponsor, the Principal Investigator and the Institutional review board.

2. Working as a Clinical Research Associate in Wockhardt Ltd since 4 months
Process :
· Identifying the Investigators and preparing investigators database
· Conducting Site feasibilities.
· Site Initiation Visits
· Conducting monitoring visits.
· Site close-out visits
· Reviewing Case study reports
· Preparing Informed consent documents.
· Reviewing Protocol.
· Attending the Investigators Meeting

Conferences/Seminars/certificates :
· Conference on “Global trends in Clinical Research : India 2008” at Hotel Intercontinental The Grand, Mumbai on March 14-15, 2008.
· National Seminar on “Recent Trends in Industrial Biotechnology” held at modern College on 9th February 2005.
· Seminar on “From Natural Ecology to Industrial Ecology” held at Modern College on 11th July 2005.
· GCP certificate for clinical research training from Pharma X.
· Advanced Data Entry Training from National Institute Of Health
· Training in Protecting Human Research Participants by National Institute of Health (U.S.A)

Poster presentation :
Secured second prize in poster presentation in National Seminar held on 9th February 2005.

Strengths :
· Confident
· Adaptable
· Focused
· Determined
· Dedicated

Achievements :
- Awarded by Help-Age India for creating awareness and raising funds for the care of elderly.

Extra curricular activities :
§ Stood first in Music competition in 1994.
§ Stood third in rangoli competition in 1998.
§ Stood first in inter-house English group song in 2000.
§ Stood fourth in inter-house Hindi quiz competition in 2000.
§ Participated in All-India Camel Colour Contest in 1998 organized by Camlin Ltd.
§ Stood first in Flower arrangement competition organized by Women forum in 2006.

Personal Details :
Date of Birth : 4th August 1986
Age : 23
Sex : Female
Marital Status : Unmarried
Languages Known : English, Hindi, and Kashmiri.

[Guest]

PRAJJUALMAKHAIK
Email : prajjvalkotgarh777 AT gmail.com

PROFILE :
I am a motivated, adaptable professional with First class degree in Bachelor in Pharmacy and Pg Diploma in Clinical Trials Research & Administration seeking an opportunity in this field. I enjoy working on my own initiative or as part of a team and see myself as a reliable, trustworthy, hardworking and enthusiastic person. In short I have a genuine interest in working in Pharmacy co-vigilance & Clinical research.

PRACTICAL SKILLS :
- Comprehensive knowledge of Adverse Events narration (AE) and guideline associated with narration of Adverse Events.
- Plan, organize, and manage daily work to meet service level timelines and deliverable.
- Skills to perform daily responsibilities in accordance to all applicable Standard Operating Procedures (SOPs).
- Sound knowledge of Drug safety process.
- Knowledge of handling submission of ICSR’s (Individual Case Safety Reports) and other reports for various regulatory authorities across the globe.
- Knowledge of Single Case Processing (both Serious & Non serious cases).
- Initial data entry of case reports into safety database / tracking system.
- Prioritize the cases.
- Knowledge of processing the adverse events received in SAE, CIOMS, and MED WATCH forms.
- MEDRA coding for the events and the case narrative.
- Knowledge of and ability to interpret and apply global safety regulations.
- Comprehensive knowledge of Good Pharmacovigilance practices, GMP, GLP and GCP guidelines.
- Proficient in using Microsoft Windows XP, Microsoft Office XP Professional.
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EDUCATION & QUALIFICATIONS :
Diploma in advanced Clinical Trials Research & Administration studies from BII, Noida in the year 2012.
GCP Certificate from Biopharma Institute in the year 2012.
Bpharma from Himachal Pradesh University scored 78% in the year 2012.

SKILLS :
- Application of modern biological procedures to applied and fundamental research.
- Team working skills.
- Information handling and literature searching.
- Oral and written communication skills.