Clinical Research Medical
Resume:
D.NAGARAJ. M.Pharm., PG Diploma in Pharmacovigilance.
Professional Objective
Successful clinical research fellow in challenging world of clinical trials providing all my escalating, Intelligent and communication efforts with skills, experience and to be an eminent & Innovative researcher in clinical research and pharmaceutical sciences.
Area of interest in Clinical research
o Drug safety associate
o Drug safety specialist
o Safety processing expert
o Phase I & II clinical trials
o Clinical research associate
Academic Credentials
M.Pharmacy
KMCH College of Pharmacy, Coimbatore.
Dr.MGR Medical University,
Chennai.
Dec 2011
PG Diploma in Pharmacovigilance
Cliniminds, Delhi.
Unit of Tenet Edutech Pvt Ltd, Delhi.
May 2010
B.Pharmacy
KMCH College of Pharmacy, Coimbatore.
Dr.MGR Medical University,
Chennai.
Feb 2009
Working Experience
Designation : Clinical research coordinator (CRC)
Department : Department of cardiology
Doctor Name & Hospital Address:
Dr.Thomas Alexander. MD., DM.
Consultant & Interventional cardiologist,
Head of department of cardiology,
Kovai Medical Center and Hospital,
P.B. No: 3209, Avanashi road,
Coimbatore. Tamilnadu-641 014.
Period : Full Time; From Mar 2009 to Jun 2010
Part Time; From Jul 2010 to Dec 2011
Full Time; From Jan 2012 to Present
Role and Responsibilities
Conducting clinical trials according to the Protocol, ICH-GCP and other regulatory requirements.
Liaison between the Sponsor, CRO, SMO, Central laboratory and Institutional review board (IRB).
Identifying the patients for the trial and to check the eligibility criteria for enrollment in the study.
Evaluate the site access to the appropriate subject population, whether the required number of subjects can be enrolled within the stipulated time.
Ensuring that informed consent (ICF) documentation and all necessary requirements of protocol are maintained appropriately in the source file.
Ensure that the enrolled study subjects are informed about their schedule of visits well in advance and that they do not miss their visits.
Entering CRF, e-CRF and resolving all queries.
Maintaining site master file (SMF) or investigator site file (ISF) as appropriate.
To manage the storage of the study drug, account for study drug received from sponsor, distributed to the patient, returned from the patient and finally back to the sponsor.
Timely submission of all the safety reports and the amendments of the trial documents to the IRB.
Reporting serious adverse events (SAE) and adverse event (AE) to the sponsor and ethics committee in a timely manner.
Clinical Research Experience
1.Coronary stent system in the treatment of a diabetic population in india. Phase-III,
Max neeman international
2.Coronary artery disease (CAD) Phase-IV Lotus clinical research
3.ST segment elevation Myocardial infarction (STEMI). Phase-IV, Lotus clinical research
4.Acute coronary syndrome (ACS). Phase-III. Siro clinpharm
5.Pulmonary artery hypertension (PAH). Phase-III, Pfizer
6.Sirolimus eluting stent in myocardial infarction (MI). Phase-III, Meril life science
7.Acute coronary syndrome (ACS). Phase-III, Torrent pharma
8.Atrial fibrillation (AF). Phase-III, Sanofi aventis
9.Decompensated heart failure (DHF). Phase-III, Sanofi aventis
10. ST segment elevation Myocardial infarction (STEMI). Phase-II, Reliance life science
Audit Faced
I have faced a sponsor audit for Decompensated heart failure (DHF) study in the year of 2009, were i have been a study coordinator.
Investigator Meeting (IM)
Participated in Investigator meeting (IM) held at Delhi on 20-22 Nov 2009 organized by SIRO clinpharm pvt ltd.
GCP and Data Capture Training
Successfully completed PPD Electronic data capture training on 28th Feb 2010.
Successfully completed Pfizer OC-RDC onsite data entry training on 25th Nov 2009.
I have successfully achieved the Pfizer certificate of competence for the following lessons on 25th and 26th Nov 2009
1.GCP and Study management
2.Informed consent
3.Safety reporting
4.Safety videos
5.Protocol overview
6.Program overview
7.Conducting 6 minute walk test
Conference Organized
I have organized the event, Kovai Lumen 2nd Collaborative STEMI Workshop held at Kovai medical center and hospital, Coimbatore on 12th and 13th Mar 2011.
Present Address:
C/O Dr.Thomas Alexander,
Department of Cardiology,
Kovai Medical Center and Hospital, P.B. No:3209,
Avanashi road, Coimbatore. Tamilnadu-641 014.
Permanent Address:
S/O P.Durairaj,
78/W4, Middle Street, Kanniservaipatti (PO),
Uthamapalayam (TK),
Theni (DT).
Tamilnadu-625 515.
Email ID:
**********@**********.***
Mobile No:
Personal Details:
Date of Birth : 12 APR 1987
Age : 24
Gender : Male
Nationality : Indian
Marital Status : Single
Languages Proficiency:
English
Tamil
Reference
Dr.Thomas Alexander. MD., DM.
Consultant & Interventional cardiologist,
Head of department of cardiology,
Kovai Medical Center and Hospital,
P.B. No: 3209, Avanashi road,
Coimbatore. Tamilnadu-641 014.
Email ID: *********@*****.***
Declaration
I Nagaraj.D, declare that the above mentioned information about me are true and complete with best of my knowledge and I am sure that if you give me a chance to work in your esteemed organization, I will full fill you expectation with my extreme effort.
Your Truly,
D.NAGARAJ
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