vijaya goud
Clinical Research Coordinator at KiMs A/S- Claim this Profile
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Bio
Experience
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KiMs A/S
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Denmark
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Manufacturing
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1 - 100 Employee
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Clinical Research Coordinator
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Sep 2010 - Present
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Study Coordinator
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Aug 2010 - Present
Assist Investigator during Informed Consent Process Attend Investigator Meetings Involve in end to end process of Clinical research study Coordinate with monitor in Site Selection, Site Initiation and Site termination Submission of study related documents to IRB/IEC for review and approval Communication with IRB/IEC for the study related queries Capturing and Recording AE's and SAE's Reporting SAE's for IEC notification Enrolling subject's, tracking subject's for the visits and follow up of subject's after the study including contact of IVRS/IWRS Maintain and update Investigator Site File (ISF) Retain source documents, complete CRF's (RDC & EDC) and solve Data Clarification Forms (DCF) Instruction and supervision of Trial Drug Administration Drug accountability and Storage of Trial medication Conducting clinical trials according to study protocol, ICH-GCP Guidelines & SOP's Trials Handling:
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Education
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2005 - 2008
wale high school
B.Sc biotech, PG diploma in clinical research, life sciences n human research -
CLINI
Post Graduate diploma, Clinical Research, Clinical Data Management and Pharmacovigilance -
Shahu College (NANDED University
BSC, Biotechnology -
Vivekanand Institute (Maharashtra) - 2005STDXII from Jaikranthi Jr College (State Board of Maharashtra)
Diploma, Lab Technician
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