Deepak Sharma
Ethics Coordinator; Documentation; Ethics Operations; Team Leader; Research Expert; Clinical Research; ICH-GCP Guidelines; Functioning of Ethics; Well-versed with Regulatory Guidelines for Clinical Research
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About
Experienced Ethics Committee Coordinator with 13 years of expertise in Institutional Review Board (IRB) operations and clinical research oversight. Skilled in managing research submissions, maintaining regulatory compliance, coordinating with investigators and sponsors, and ensuring ethical standards in clinical research. Proficient in clinical trial coordination and institutional governance.
Experience
Coordinator in Drug Trial Ethics Committee & Institutional Ethics Committee at Dayanand Medical College & Hospital (2009-12 – Present)
Ethics Committee (IRB) Coordinator ensuring efficient and compliant review of research submissions and maintaining regulatory records
- Having thorough knowledge of and ability to apply IRB Policies and Procedures
- Overseeing the accurate and timely processing, tracking, and filing of submissions to and actions by the IRB committee
- Effectively communicating with Investigators, Sponsors, Chairs, and IRB members
- Obtaining and distributing information required for IRB Chair or IRB review, maintaining files, preparing and distributing minutes
- Assisting the Secretary of Ethics Committee in file review, processing, and other duties as assigned
- Recording and creating meeting minutes in sufficient detail to document IRB deliberations
- Documenting communications with Sponsors, Investigators, regulatory entities, and any others involved in the conduct of submitted research
- Maintaining an accurate and comprehensive database of reviewed and approved research
- Maintaining records of expedited reviews, risk determinations, and any other activities that result in a review or action by Office of Research staff or IRB members
- Maintaining, filing and archiving systems that allow access to open and closed studies
- Issuing timely letters and notifications of IRB actions to Investigators and other appropriate person or entities
- Making Investigators aware of due dates for submission of renewal and other reports
- Ensuring that information submitted by Investigators has the necessary elements
- Answering questions and supplying information when requested, and conveying IRB actions to appropriate individuals
- Screening subject inquiries and resolving issues when possible, and conveying results of interactions with subjects to Investigators, Sponsors, and IRB members as directed
- Reviewing claims of exemption for the IRB
- Providing support to the IRB Chairperson and Secretary, in the recruitment, training, and continuing education of IRB members
- Appraising the Chairperson of IRB membership status and advising when additional or new regular or alternate members are required
- Responsible for the IRB / DTEC monthly Meetings to decided date, time and venue of the meetings
- Responsible for office front end and back end activity
- Instill sense of responsibility in all the categories of persons
- Stock Holder of Department's Inventory
Customer Care Executive cum Computer Operator at WWIL (Wire & Wireless India Private Ltd) in Zee Networks (2009-01 – 2009-12)
Customer care and data management role in telecommunications company
- Tele Calling
- Listening to Clients Problems and solving queries of Clients
- Data Entry in MS Office
- Working on Internet (receiving & sending data through internet to all branches of company)
- All duties assigned by the seniors time to time
Customer Care Executive cum Computer Operator at Fastway Transmission Private Limited (2009-06 – 2009-12)
Customer care and data management role in transmission company
- Tele Calling
- Listening to Clients Problems and solving queries of Clients
- Data Entry in MS Office
- Working on Internet (receiving & sending data through internet to all branches of company)
- All duties assigned by the seniors time to time
Education
10+2 in Commerce – Punjab School Education Board (2005 – 2007)
B.Sc in Information Technology – Punjab Technical University (2007 – 2011)
MCA in Master of Computer Applications – Punjab Technical University (2012 – 2014)
