Clinical Research Training
Resume:
Curriculum Vitae
Lenin.P
NO: **, Pandiyarajan st, MGR nagar, Selaiyur, Agaram main road, Chennai: 600073Tamilnadu, India. E-mail:*****.*****@*****.***, Mobile: +91-994*******
Academic Background
Periyar University (Distance education)|2010-2012
Master of microbiology (pursuing)
Selam-636011
Vel’s College of science (University Of Madras) |2005-2008
Bachelor of Science in microbiology
Pallavaram, Chennai-600073
Jaigopal Garodia national higher secondary school |2003-2005
Biology
Tambar am Sanatorium, Chennai- 600059
Additional Educational
Qualification Consortium Clinical Research Organization |2008
Post Graduate Diploma Clinical trail management and regulatory affairs.
Kovaiputhur, Coimbatore-
Work Experience
Micro Therapeutics Research Labs Pvt ltd |2010- till date
Clinical Research Associate
Chennai
Consortium Clinical Research Pvt. Ltd, |jan 2009-june2010
Clinical Research Associate
Kovaiputhur. Coimbatore
Clinical Research
Experience Consortium Clinical Research Pvt. Ltd. Delhi| Jan 2009 to Aug 2009
Completed study in Nutritional supplement product (Community based periodic study)
Dr.Reddy’s laboratories |August 2009 to February 2010
On behalf of Consortium Clinical Research Pvt. Ltd.
Reditux PMS study at 3 sites in Chennai.
Worked as a CRA
Dr.Reddy’s laboratories | August 2009 to February 2010
On behalf of Consortium Clinical Research Pvt. Ltd.
Grafeel PMS study at Chennai
Worked as a CRA
Consortium Clinical Research Pvt. Ltd. |2010
Pre-study preparatory works for a BA/BE and a Phase I trials and conducting protocol training sessions for the subordinates.
Micro Therapeutics Research Labs |2010 – till date
Worked on above 120 BA/BE studies as a Study monitor for.
Responsibilities
Investigator Identification and Selection
Ethics Committee Submissions and follow-up
Completion of CRF, LOGS, and study specific documents
Preparation for Investigator Meeting
Preparation for In-House and Site Audit
Investigational Product Handling
Serious Adverse Event Reporting
Protocol, IB and ICF review,
Coordination with Vendors e.g. Translators, Courier Services.
Underwent Training
Consortium Clinical Research Pvt. Ltd Coimbatore |Aug 2008.
Protocol Details, SAE reporting and Timelines for reporting, Pharmacovigilance, Schedule Y, ICH guidelines and Good Clinical Practice sessions
BA/BE Study protocol, Study logs and Specific documentation training.
PMS study of Liposomal Doxorubicin HCL study protocol, study logs and Specific documentation training.
PMS study of Albumin Bound Palitaxel study Protocol, Study logs and Specific documentation training.
PMS study of Erlotinib study Protocol, Study logs and Specific documentation training.
Dr.Reddy’s at Hyderabad H.O. | Aug 2009.
PMS study of Reditux study protocol and study Specific documentation training
Dr.Reddy’s at Hyderabad H.O. |Aug 2009PMS study of Grafeel study protocol and study Specific documentation training.
Oncology study Protocol and Specific documentation training.
Neutraceutical Seeding program/User trial, study protocol and study specific documentation training.
Software Knowledge
Proficient in Windows XP Operating Systems
Good Knowledge on MS Word, Excel, PowerPoint & Internet Explore
Personal Information Date of Birth: 5 July 1989
Place of Birth: Chennai, Tamil Nadu
Civil status: Single
Citizenship: Indian
Declaration
All information provided in this resume is true to the best of my knowledge and authentic.
Place: Chennai Yours truly
Date: (LENIN.P)
Contact this candidate