Clinical Research, Project Coordinator

Babita

H.No.:-**, AaliVihar, H-Block

Krishna Gali, N.D-110076

Mobile; 991*******

Email :- ******.****@*****.***

Objective

• To work in a challenging environment in field of Research & Health, where I can contribute my

knowledge and experience in yourOrganization.

Area Of Interest

• CTA, CRC,CRA, Research assistant, Research Associate etc

Working Experience

Currently working at CCDC on Project of PHFI as Field Interviewer.

1 Year Trainee Clinical Research Coordinator,

Apollo Hospitals Educational and Research foundation, New Delhi

Clinical Trials Studies

A phase III multicentric study on Metastatic Breast Cancer (Blinded Investigational

Product Coordinator) .

Working in ICMR project on NAFLD.

Working with pharmacovigilance committee in Indraprastha Apollo Hospitals.

Working in PHFI project on CARRS.

Working in PHFI Sub Study on PCOS.

Key Responibilities

Maintain protocol requirements for schedules patient visit, test procedures, and drug

accountability requirements

Interact with clinical research associate to facilitating monitoring and database clean-up

process

Performing, IWRS to randomize the subjects, and allocation of Investigational Product

Assisting informed Consent Process(ICF) and proper documentation of the process

Receipt & shipment of IP, Lab kits, along with processing and packing of the samples

Creating Source document, CRF and e-CRF filling and resolving queries generated

Maintain study files on an ongoing basis to ensure that the files are complete.

Preparation and Notification of AE and SAE occurred at the site and other sites to Ethics

Committee (EC)

Preparation of synopsis for EC submission, submitting all the trial related documents

to EC for their approval

Conduct interviews of eligible subjects on Standardized questionaries at baseline and

then on early basis.

Perform anthropometric & clinical measurements & prepare weekly progress report.

Maintain record of all individuals, ensure their timely follow-up.

Provide support in data management & related task

Counsel enrolled individuals on giving biological specimens & facilitate its collection

process.

Follow-up of defaulter cases.

Workshop and Seminars

Attended GCP Workshop by Quintiles Ltd. held at Apollo Hospitals, New Delhi.

Attended International Pharmacovigilance seminar held at Indraprastha Apollo

Hospital New Delhi. November 2010

Educational Qualifications

DEGREE NAME OF INSTITUTE TOTAL MARKS

Post Graduate Certificate ApolloHospital Educational & 70%

in Clinical Research Research Foundation, New Delhi

B.Sc. Biotechnology PIPRAMS affiliated to 64%

C.C.S.University

12th As a private candidate 46%

10th G.G.S.S.School 58%

Computer Skills

Basic knowledge about: MS word, MS Power point, MS Excel.

Key Skills

Sound knowledge on Schedule-Y, ICH-GCP (E6) guidelines,

Personal Details

Father’s Name :- Mr. R.K.Chauhan

Marital Status :- Single

Gender :- Female

Language :- Hindi and English

Hobbies :- Listening music, watching movies

References

Prof. V.S Mathur, Chief Coordinator Dr. VibhaDhingra, Associate

Coordinator

Clinical Research Course Clinical Research Course

Apollo Hospital Educational and Research Apollo Hospitals Educational and

Research

Foundation Foundation

Indraprastha Apollo Hospitals, SaritaVihar, Indraprastha Apollo Hospitals, SaritaVihar,

New Delhi – 110076 New Delhi - 110076

Mobile :+91-981******* Mobile :+91-981*******

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

Babita

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