Clinical Research Management
Resume:
Amruta Rajaram Nalawade.
******.********@*****.**
***********@*****.***
KEY SKILLS:
Knowledge of the clinical research and chemistry. Excellent organization, planning and problem solving abilities. Negotiation and time management skills.
OBJECTIVES:
• To utilize my skills and abilities in impacting the success and growth of company as a leader in the clinical research industry. To obtain a position in Clinical Research field where I will get a chance to utilize my knowledge. I seek to enhance my education through practical exposure to work environment of a profession and be an asset for the same.
WORK EXPERIENCE:
Study coordinator (CRC): Working as a clinical research co-coordinator with an Investigator.
Investigator : Dr. Sanjiv Shah (Diabetologist and Endocrinologist).
Duration : October 2010 to November 2011.
Therapeutic Areas : Diabetes & Endocrinology.
RESPONSIBLITIES:
Site Coordination and management
• On–site Coordination of the overall conduct of the study to ensure compliance with protocol, GCP and regulatory requirement.
• Explain patient in brief about project or clinical study.
• Coordinating patient visit and visit specific assessments.
• Assisting Informed Consent Form (ICF) administration to Investigator.
• Preparing, updating source documents and eCRF on real time basis, resolving data queries.
• Doing Interactive voice response system (IVRS) or Interactive web response system (IWRS) and dispensed medicine to the patient.
• Communicating with EC on regular interval for the study related submissions, approvals and study status reports.
• Identify and reporting SAE to sponsors and Ethics Committee within given timeline.
• Communicating with other venders involved in the trail coordination like Central pharmacy, Central Lab, and Couriers for effective and smooth process.
• Assists in patient recruitment and retention for long term follow up in the study.
• Responsible for the filling, maintenance and updating Trail Master File (TMF).
• Help CRA in monitoring visits.
• Record daily temperature and see availability of blood collection kits.
• Check expiry of investigational product and updating all logs daily.
• Guide lab staff for blood collection tubes and taking vital sign.
• Participate in team meetings and activities related to the study.
ACADEMICS:
Qualification Institute University Year of Passing
Post Graduate Diploma in Advance Clinical Research (PGDACR)
Institute of Clinical Research (ICRI)
Mumbai April –2011
B.Sc (Chemistry) Bhavan’s College University of Mumbai
April-2010
H.S.C Bhavan’s College Maharashtra State Board
Feb.-2007
S.S.C Dnynsagar vidyalaya Maharashtra State Board March-2005
SPECILLISATION:
Diploma in clinical research from ICRI (Andheri East).
Chemistry.
THESIS:
Techniques available and resent advances in management of Type 2 Diabetes Mellitus.
PROJECTS/PRESENTATIO:
Prepared presentation on- History of Clinical Research,
Lung Cancer,
Viral Disease,
Respiratory System.
Study Report:
Prepared study report on – Vioxx.
SEMINAR ATTENDED:
“Brand success: Highlights on safety aspects” on 27th November 2010, at Bharti vidyapeeth’s College of Pharmacy, Navi Mumbai.
OTHER QUALIFICATION:
I.T skill:
From Keerti Computer Institute done Keerti Professional course specialization in Windows-XP, Ms-Office 2003, Tally 9, D.T.P., Flash, HTML, DHTML, Java Script Dreamweaver, Fireworks, Gif Animator and Internet.
STRENTHS:
• Great team player.
• Managing time according to work.
• Hard worker.
PERSONAL DETAILS:-
ADDRESS: 153, ‘H’wing,
SBI staff colony, Raheja town ship,
Malad (E), Mumbai- 400 097.
CONTACT DETAILS: 987*******.
DATE OF BIRTH: 9th Dec 1989.
NATIONALITY: Indian.
MARITAL STATUS: Single.
LANGUAGE KNOWN: English, Marathi, Hindi.
REFERENCES:
1) Dr. Sanjiv Shah. (M.D. Endocrinologist).
2) Mr. Shovan Baidya. (Professor of ICRI).
3) Ms. Ankita Saraswat. (Professor of ICRI).
4) Ms. Aditi Sawardekar. (Professor of ICRI).
DECLARATION:
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.
Place: Mumbai
Date: AMRUTA NALAWADE.
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