About this role
<div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Job Description</H2> </div><div><ol style="margin-top:0.0in;margin-bottom:0.0in" start="1" type="1"> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:10.0pt;line-height:115%;font-size:11.0pt;font-family:Calibri, sans-serif">Monitoring of outsourced clinical BA BE studies at external CROs as per protocol & applicable regulatory guidelines</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:10.0pt;line-height:115%;font-size:11.0pt;font-family:Calibri, sans-serif">To Coordinate with external CRO representative for technical discussion & study Update.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:10.0pt;line-height:115%;font-size:11.0pt;font-family:Calibri, sans-serif">To review TMF , screening MSR, ICD, period CRFs , dosing, sample collection, sample processing etc during monitoring visit.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:10.0pt;line-height:115%;font-size:11.0pt;font-family:Calibri, sans-serif">Planning, execution & supervision of inhouse BA BE studies as a clinical research coordinator.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:10.0pt;line-height:115%;font-size:11.0pt;font-family:Calibri, sans-serif">To Coordinate inhouse BA BE studies starting from protcol training , TMF Compilation , study planning, preparation of study updates, resolution of study queries.</li> <li style="margin-top:0.0in;margin-right:0.0in;margin-bottom:10.0pt;line-height:115%;font-size:11.0pt;font-family:Calibri, sans-serif">To ensure proper raw data documentation during the clinical study phases.</li> </ol></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Work Experience</H2> </div><div><p>3-5 years of relevant experience.</p></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Education</H2> </div><div><div>Masters in Pharmacy</div></div></div><div style="padding:10.0px 0.0px;border:1.0px solid transparent"><div style="font-size:16.0px;word-wrap:break-word"><H2 style="font-size:1.0em;margin:0.0px">Competencies</H2> </div><div></div></div></div>