Job openings for M.Pharm, M.Sc to work as CRA at Clinical Development Services Agency | Emoluments upto Rs 45,000/- pm
Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an extramural unit of Translational Health Science & Technology Institute (THSTI). It was created to facilitate development of affordable healthcare products for public health diseases. Registered as a not-for profit research organization, it aims to develop an eco-system for training and learning and work with public sector institutions, and small and medium enterprises (SME) to translate innovative technologies into medical products for public good.
Post : Clinical Research Associate (iKMC Study)
Age Limit : Upto 40 Years
Emoluments/ Duration : Upto Rs. 45,000/- per month consolidated, 24 Months
Location : Safdarjung Hospital, Delhi
Overall responsibilities are to ensure that the study is conducted in accordance with study protocol, standard operating procedures, good clinical practices, and applicable guidelines.
• Performs site monitoring activities in accordance with contracted scope of work
• Completes induction program including appropriate therapeutic, protocol and clinical research trainings to perform job duties.
• Acts as communication channel while facilitating effective communication among investigators, CDSA and key stakeholders
• Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Verifying that data entered on to the CRFs is consistent with patient clinical notes (source data/ document verification)
• Conduct process monitoring of the assigned study
• Manages the progress of assigned studies by tracking EC submissions and approvals, subject enrolment, protocol compliance, clinical data collection including CRF completion, and data query generation and resolution.
• Archiving study documentation and correspondence
• Ensure that study is conducted, recorded and reported as per protocol, guidelines and applicable regulations & help ensure quality and integrity of clinical data.
• Escalates quality issues to the project coordinator /senior management and work with study team for implementation of action plan for resolution of issues.
• Work closely with Clinical Portfolio Management department and/or other internal departments as and when required
Qualifications and Experience
Medical /Allied bachelor’s degree or Master’s degree in life sciences/pharmacy/healthcare or other related discipline or diploma/ post graduate degree in Clinical Research
2-3 years of clinical operations /monitoring /site coordination experience in clinical trials / research projects
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