Job Openings for Pharmacy professionals (9 posts) to work in ICMR as Consultant | Salary upto Rs 1 lakh per month

 

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.

Under Project ‘India TB Research Consortium’

Consultant (Scientific) Clinical Operation

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.
OR
MBBS or equivalent with four year of demonstrated experience in clinical research /trial from reputed Institutions.
OR
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.

Desirable
• 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 p from site selection till execution of the clinical studies/clinical trials under ITRC.    .
• Designing and completing feasibility questionnaire and checklists for site evaluation
• Prepare plans/Checklist for site preparation, site assessment initiation, study documentation at site. Responsible for the project planning, project preparation, review ol the study documentation.
• Schedule and conduct onsite visits for preparedness including compilation tracking quality issues, assessing criticality, execution of corrective and preventive action Site initiation and smooth implementation at sites.
• Ensuring preparedness of resources and initiation support to sites responding to queries (follow-up)
• SOP preparation, Coordinate study preparedness activities along with on site training of the site staff setting up plans Setting up documentation standards to ensure compliance with guidelines and regulations
• Coordinate study preparedness activities, including training on project implementation, communication and information dissemination. Shall also provide necessary guidance to the study team at all sites as and when required.
• Establish and ensure that all processes for conduct of clinical trials, performance of CRFs, data management etc. are in place for ensuring expected performance.
• To prepare and/or reviews study-related Stand aid Operating Procedures and documents.
management of Individual Case Safety Reports (ICSRs), Case Report forms (CRT)
• Regulatory relevance determination, initiation/registration of ICSRs into the safety database, Quality review y 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
• Troubleshoot for smooth execution ol clinical trials and multi-
centric projects.
• prepare and assist in preparing annual reports and qualitytrending
reports
• Keep upto date with all quality and complianeeissues.
• To provide study-specific training and leadership to clmica research staff, including CRO, CRAs, sites and other contract
• To plan, organize and conduct study-specific meetings (e.g. Study Management Meetings, investigator meetings, visor Committee).

Consolidated Emoluments : Rs 70,000/- per month consolidated.

Tenure : One year

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

Place of work : ICMR/DHR, New Delhi

 

Consultant (Scientific) Biomedical Research

Essential Qualifications :
Post Graduate Degree (MD/ MS/ DNB/ Ph.D) afters MBBS with one year of demonstrated experience in clinical research/Biomedical Research from reputed Institution.
OR
MBBS or equivalent with four year of clinical experience in Government Institution of which 2 years should be demonstrated experience in clinical research/Biomedical Research from reputed Institution.
OR
1st class Masters in M.Pharma, M.Sc in Pharmacology/Medical microbiology/ Biochemistry/ Biotechnology with 4 years of demonstrated Experience  in clinical research /Biomedical Research from reputed Institution
OR
2nd class masters in M.Pharm , M.Sc in Pharmacology/Medical Microbiology /Biochemistry/ Biotechnology / Clinical Research with  Ph.D in any of the above disciplines with 2 years’ post Ph.D demonstrated experience of clinical research/trial.

Desirable
• 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 GCP, GCLP, ICH guidelines and regulatory requirements  for conduct of clinical trial.
• Good communication skills

Age Limited as on date : up to 70 years

Nature of duties
• Complete coordination of all project activities related to ITRC and take forward the projects in all thematic areas from initiation till execution and Implementation at all sites.
• Ensure that all processes contributing to the performance of clinical trial are conducted properly.
• Troubleshoot clinical trials and multi-centric projects.
• To monitor the performance of all the other staff and ensuring the compliance by each of them
• Support the writing team in Literature review and preparation of study protocols for TB related clinical trials, ensuring the compliance and actions related to projects and trials are processed in time and action taken to rectify the related matters.
• Coordinating with Regulatory team for and preparation of study protocol to DCG1 office
• Preparing and Convening Investigators meetings for finalization of protocols and Organizing & co-coordinating protocol review meets whenever required by ITRC.
• Coordinating with other divisions of ICMR for getting inputs related to various issues like 1PR, legal. Financial, administrative etc. for their inputs.
• Preparation of various protocol related documents as per WHO, DCGI guidelines
• Preparing project management plan, Clinical data management plan, support and review CRT development and organize training of the project staff for the protocol and also for electronic data entry.
• Writing scientific papers for publications in various journals Frequent All India travel to clinical trial sites for ensuring compliance with protocol and timeline.
• Any other work assigned by the team leader/programme officer.
• Keep upto date with all quality and compliance issues.
• The job may require frequent All India travel to sites for monitoring, quality assuranceand qualitymanagcmcnt.
• Any other job assigned by the PI or Programme officer

Consolidated Emoluments : Rs 70,000/- per month consolidated.

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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