Career for Clinical Research Associate at CDSA | Salary upto Rs 60,000 - Masters degree/ diploma in life sciences, pharmacy
Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
Post : Clinical Research Associate II
(An Open-label, non-randomized Two-stage, Dose Finding study of Verapamil tablet formulation in Adult TB patients in Continuation Phase)
Consolidated salary per month : Up to Rs. 60,000/-
Duration : The study duration is two years. The initial appointment will be for a period of one year to be continued subject to performance.
Age : Up to 45 years
The Study Monitor/ Clinical Research Associate conducts monitoring visits for assigned study protocol and study sites. Overall responsibilities are to oversee the progress of assigned clinical study to ensure that the study is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
Key responsibilities for CRA include following;
• Performs site preparedness / start -up, site initiation and site monitoring (throughout the trial which involves visiting the trial sites on a regular basis) and close-out visits in accordance with contracted scope of work
• Performs quality functions and execute quality programs (clinical operations, clinical laboratory) to ensure compliance with protocol, SOPs, Good Clinical Practices guidelines and applicable regulations.
• Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
• Ensures that each study site has the adequate clinical trial supplies and equipment (including the investigational product, as applicable) and ensure 100% accountability of the same.
• Administers / facilitate protocol and other related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• May provide training and assistance to junior clinical staff
• Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
• Manages the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, recruitment and enrolment, CRF completion and submission, and data query generation and resolution.
• Perform source data review and source data verification (to ensure that data entered on to the CRFs is consistent with patient clinical notes / source documents
• Writing site visit reports and follow-up letters within the timelines as per the SOPs / project requirement.
• Filing and collating trial documentation and reports.
• Archiving study documentation and correspondence
• Evaluates the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations.
• Escalates quality issues to the Quality Manager, Project Manager and/ or senior management
• Work with Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required
• Bachelor’s in medical sciences or Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred
• Minimum 3 years of relevant clinical trial/ study monitoring experience
• Computer skills including proficiency in use of Microsoft Office applications
• Basic knowledge and ability to apply GCP and applicable regulatory guidelines.
• Strong written and verbal communication skills including good command of English required.
• Excellent organizational and problem solving skills.
• Effective time management skills and ability to manage competing priorities
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