THSTI Pharma CRA Consultant Vacancy – Salary Rs 60,000/- per month
Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the Department of Biotechnology, Ministry of Science and Technology, Govt. of India. The institute is an integral part of the interdisciplinary NCR Biotech Science Cluster located at Faridabad.
Job Title: Consultant CRA
Name of the Study Digoxin trial Study title:-“Digoxin in patients with rheumatic heart disease – a randomized placebo-controlled Trial”
Emoluments (Consolidated) Upto Rs. 60,000/- per month
Duration One year (To be extended as per the requirement of the Project)
Age Limit Upto 45 years
Location CDSA, Faridabad
Job profile CRA will conduct monitoring visits for assigned trial protocol and
trial sites. Overall responsibilities are to ensure that the trial is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
• Performs site monitoring throughout the trial which involves visiting the trial sites on a regular basis (site initiation to site closeout) in accordance with contracted scope of work
• Performs quality functions and executes quality programs (clinical operations, clinical laboratory) as per GCP and regulations
• Completes appropriate therapeutic, protocol and clinical research training to perform job
duties.• Setting up the trial sites such that each center has the trial materials, including the trial drug while ensuring all trial supplies are accounted for
• Administers protocol and related trial 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 trial 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.
• Verifying that data entered onto the CRFs is consistent with participant clinical notes (source data/ document verification); continuous central monitoring and ensuring the timely resolution of queries by the site team
• Writing visit reports and follow-up letters within the timeline
• Filing and collating trial documentation and reports.
• Archiving trial documentation and correspondence
• Evaluates the quality and integrity of trial 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
Qualifications and Experience
• Bachelor’s in medical sciences or Master’s degree/ diploma pharmacy, public health, MBBS, BDS, BHMS, BAMS, BPT healthcare, or other related disciplines
• At least 4-5 years of relevant clinical trial monitoring experience
Skills
• Computer skills including proficiency in the 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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