Recruitment for M.Pharm as Consultant in Clinical Operation at ICMR - Salary Rs 60,000/- per month

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The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. As early as in 1911, the Government of India set up the Indian Research Fund Association (IRFA) with the specific objective of sponsoring and coordinating medical research in the country. After independence, several important changes were made in the organisation and the activities of the IRFA. It was redesignated in 1949 as the Indian Council of Medical Research (ICMR) with considerably expanded scope of functions.

Post : Consultant (Scientific) Clinical Operation

For Project India TB research Consortium under 'Tata Trusts'

Essential Qualifications :
Post Graduate Degree (MD/MS/DNB) after MBBS with one year of 1 demonstrated experience in clinical research/trial from reputed t institutions.
MBBS or equivalent with four year of demonstrated experience in clinical research /trial from reputed Institutions.
1st class Masters in M.Pharma or M.Sc in Pharmacology/Medical Microbiology/ Biochemistry/Biotechnology/ Clinical Research with 4years of demonstrated experience of clinical research/trial
OR .
2ndclass Masters in M.Pharma , M.Sc in Pharmacology/Medical Microbiology/ Biochemistry/Biotechnology/ Clinical Research with ph.D with 2 years post Ph.D demonstrated experience of clinical research/trial.

• Experience in implementing / conducting and all aspects of regulatory Vaccine/drug trial/clinical research.
• Experience in establishing clinical trial sites, management & implementation of trials and managing and maintaining databases for quality systems.
• Able to write& review SOPs and logs relevant requirement for trial sites.
• Able to prepare project management plan, study monitoring pan for regulatory clinical trials
• Thorough knowledge of Schedule Y, new clinical trial guidelines. GCP, GCLP, ICH guidelines and regulatory requirements am new clinical trial rules for conduct of clinical trial.
• Good communication skills

Age Limited as on date : up to 70 years

Nature of duties
• To develop the project management and site monitoring plan from site) selection till execution of the clinical studics/clinical trials under ITRC
• Designing and completing feasibility questionnaire and checklists for site) evaluation
• Prepare plans/Check list for site preparation, site assessment i initiation,! study documentation at site. Responsible for the project planning, project) preparation, review of the study documentation.
• Schedule and conduct onsite visits for preparedness including compilation tracking quality issues, assessing criticality, execution.
• To prepare study monitoring plans for each study/clinical trial and participate in site monitoring visits as appropriate and oversee clinical monitoring activities ensuring compliance with Good Clinical Practices (GCP) and applicable regulations.
• management of Individual Case Safety Reports (lCSRs), Case Report] forms (CRF)
• Regulator relevance determination, initiation/registration of lCSRs into the safely database. Quality review
• Prepare and assist in preparing annual reports and qualilvtrending reports
•  work in team and undertake and share the responsibilities as and when required with other ITRC staff.
•  The job may require frequent travel to sites for monitoring, quality assurance and qualitymanagement.

Consolidated Emoluments : Rs 60,000/- per month consolidated depending upon experience and knowledge

Tenure : One year

Syllabus for written examination : Degree level related to project work, if written test Conducted

Place of work : ICMR/DHR, New Delhi

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