Career for Clinical Research Associate at CDSA - Ministry of Science & Technology | Emoluments Up to Rs. 45,000 pm
Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India launched CDSA on 28 September 2009 as an autonomous organisation and 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
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
• Excellent reading comprehension and strong written as well as verbal communication skills including good command of English required
• Computer skills including proficiency in use of Microsoft Office applications
• Good knowledge and ability to apply GCP and applicable regulatory guidelines
• Good organizational behavior and problem solving skills
• Effective time management skills and ability to manage competing priorities.
• Ability to establish and maintain effective working relationships with co-workers, managers, investigators
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