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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Consultant (Scientific) Clinical Coordinator

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 conducting Vaccine/drug trial/clinical research/Biomedical Research.
• Experience in managing and maintaining databases for quality systems..
• Able to prepare SOPs, project management plan and study monitoring plan for trial conduct.
• 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
• Co-ordinate the activities of the India TB Research consortium
• Ensure that all processes contributing to the performance of a clinical trial are conductedproperlyas per the ITRC SOPs and consolidate the information pertaining to all the projects and activities undertaken or proposed to be undertaken under ITRC and would be responsible for finishing the assigned tasks on time.
• Troubleshoot clinical trials and multi-centric projects.
• Prepare and assist in preparing annual reports and quality trending reports.
• Report the status of the quality levels of the staff, systems and production activities.
• To organize meetings, take care of logistics and administrative and financial approvals, draft letters for sending to various organizations and prepare the draft minutes of the meeting
• Keep upto date with all quality and compliance issues.
• Process matters for sanction of the projects as recommended by expert groups of ITRC, take follow-up actions till release of budget.
• To obtain the updated progress reports from sites and also consolidated reports from the project co-ordinators and regularly submit to ITRC Program officer
• To work in team and undertake and share the responsibilities as and when required with other ITRC staff.
• The job may require frequent All India travel to sites for monitoring, quality assurance and quality management.
• 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

Consultant (Scientific) Clinical Development

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 conducting clinical research/Biomedical Research.
• Experience in managing and maintaining databases for quality systems..
• Have medical writing skills for writing protocols/ clinical study reports/ prepare CRFs, proforma etc
• Able to prepare SOPs, project management plan and study monitoring plan for trial conduct.
• 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
• Work as per the ITRC SOPs and undertake new project clinical trial development plan.
• Prepare the SOPs for the project/clinical trial under ITRC and ensuring the compliance with activity and the project targets.
• Prepare clinical trial plan with the new leads/molecules and submit to the team lead with details in a time bound manner.
• Co-ordinate the activities of the India TB Research consortium
• Ensure that all processes contributing to the performance of aclinical trial are conducted properly.
• Prepare monthly status update report of the performance with targets set and achieved and submit to PO monthly.
• Prepare minutes of meetings and take follow-up actions
• Report the status of the quality levels of the staff, systems and production activities.
• Keep upto date with all quality and compliance issues.
• The job may require frequent All India travel to sites for monitoring, quality.
• 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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For Project Management Unit for 'TB Vaccine Trial'

Consultant (Senior Project Manager)

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 conducting clinical research/Biomedical Research.
• Experience in establishing clinical trial sites, management 8c 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
• Establish and ensure that all processes for conduct of vaccine trials, CRFs, data management etc. are in place for ensuring expected performance.
• Prepare detailed project management plan and safety management plan and ensure execution as per plan.
• Prepare data management plan with data manager and ensure preparation of statistical analysis plan with help of statistician.
• Communicate with sites for ensuring smooth conduct and support as and when required.
• Co-ordinate with monitoring team for study compliance and management/monitoring and obtain weekly updated reports team.
• Submit updated site specific and consolidated progress report to Team leader/ Programme officer every week Troubleshoot with all sites for smooth conduct of vaccine trial, Prepare SAE management plan and Prepare and assist in preparing adverse event / serious adverse event narratives, safety reports, progress reports and quality trending reports.
• Will be responsible for site initiation and site management, monitoring timely reports of adverse event / serious adverse event by site Pls and communication with regulators.
• Report the status of the quality levels of the staff, systems and production activities.
• Keep upto date with all quality and compliance issues.
• Prepare interim and final Clinical report as per guidelines.
• Prepare relevant documents (note to files, protocol deviations etc.) and ensure timely submission to sponsor, IECs and Regulators.
• The job requires frequent All India travel to sites for monitoring, quality assurance and quality management.
• Ensuring operational approach of the vaccine trial arc in place
• Any other duty assigned by the PI or Programme officer.

Consolidated Emoluments : Maximum Rs. 1,00,000/- per month depending upon experience and knowledge.

Tenure : Initial for one year and may continue upto three Years

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

Place of work : ICMR/DHR, New Delhi

Consultant (Scientific) Clinical Service - Two posts

Essential Qualifications :
Post Graduate Degree (MD/MS/DNB/Ph.D) after MBBS with one year of demonstrated experience in Vaccinc/drug trial/clinical research/Clinical management from reputed Institutions.
OR
MBBS or equivalent with four year of clinical experience in Government Institution of which 2 years should be demonstrated experience in regulatory Vaccinc/drug trial/clinical research from reputed Institutions

Desirable
• Experience in conducting Vaccinc/drug trial/clinical research/Clinical Management.
• Able to prepare safety reports and ensure the timely management and reporting of AEs an SAEs by sites by supporting them
• Experience in managing and maintaining databases for qualitysystems.
• Able to prepare SOPs for trial conduct and write safety reports and SAP' narratives.
• Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct.
• Good communication skills

Age Limited as on date : up to 70 years

Nature of duties
• Monitor the clinical trial and Prepare strategy for site monitoring and timely completion of recruitment targets and follow -up visits
• Checking of resources and Site initiation
• Monitor vaccine trial, check all the source documents and completeness of data CRFs and ensuring timely completion of data entry in compliance with study protocol.
• Review SAE tracker and SAE document repository every 15 days
• Prepare a patient tracker and discuss with site PI to ensure compliance and minimize missing visits of subjects
• To match the tracker every week against recruitment target for each site and take necessary actions accordingly
• Discussion with Pi’s and project staff for patient compliance
• Review of Ensure that all processes contributing to the performance of aclinical trial arc conductedproperly.
• Prepare and assist in preparing annual reports and quality tr ending reports.

Consolidated Emoluments : Maximum Rs. 80,000/- per month depending upon experience and knowledge.

Tenure : Initial for one year and may continue upto three Years

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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Consultant (Project Manager) - Two posts

Essential Qualifications :
MBBS/BAMS or equivalent with 4 year of demonstrated core clinical experience of managing/monitoring of regulatory clinical trials specially Vaccine/drug trial/clinical research from reputed Institutions.
OR
1st class Masters M.Pharma or M.Sc in Life sciences with4 years of core experience in managing/monitoring of regulatory clinical trials specially Vaccine/drug trial from reputed Institutions
OR
2nd class Masters in M.Pharma/M.Sc in life sciences with Ph.D and 3 years of post Ph.D demonstrated core experience in managing/monitoring of regulatory clinical trials specially Vaccine/drug trial from reputed Institutions

Desirable
• Experience in conducting/managing and monitoringregulatory clinical research/ trials and carry out all the activities related to regulatory trials
• Experience in checking all source documents and cross check data entry in CRFs.
• Experience in managing and maintaining databases for quality systems.
• Able to prepare SOPs, logs etc. for trial conduct.
• Thorough knowledge of New clinical trial guidelines, Schedule Y, GCP, GCLP, ICH guidelines and regulatory requirements for clinical trial conduct.
• Good communication skills

Age Limited as on date : up to 70 years

Nature of duties
• Able to execute the project monitoring plan for a regulatory preventive vaccine clinical trial.
• Prepare for Site initiation and Monitor vaccine trial, check all the source documents and entry of data in CRFs and ensuring timely completion of data entry and compliance with study protocol and completion of recruitment target.
• Ensure that all processes contributing to the performance of aclinical trial are conductcd properly.
• Should be able to provide Training on study procedures, safety reporting, GCP, regulations & GDP and Dry run of activities
• Troubleshoot processes for smooth conduct of multicentric regulatory vaccine trials
• Prepare study progress reports and quality trending reports.
• Report the status of the quality levels of the staff, systems and activities and should be able to provide training in project conduct related activities of the vaccine trial.
• Keep upto date with all quality and compliance processes and issues.
• Any other job assigned by the PI or Programme officer
• The job may require frequent All India travel to sites for project management and monitoring, quality assurance and quality management and should be able to travel at least 15 days a month for study monitoring

Consolidated Emoluments : Maximum Rs. 70,000/- per month depending upon experience and knowledge.

Tenure : Initial for one year and may continue upto three Years

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

Place of work : ICMR/DHR, New Delhi

SELECTION PROCEDURE:
Interview will be conducted of the eligible candidates. However, if more number of candidates found eligible for the post advertised, Written Test/ Skill Test may also be conducted on the same day before final round of interview.

The candidates should bring 5 copies of Bio data along with all original certificates of educational qualifications (from SSC onwards), experience, Aadhaar Card, with two set of photocopies of the supportive documents duly attested (can be self-attested) along with a passport size photograph for attending the Written Test/ interview.

The appointment is purely on contractual basis. No TA/ DA will be paid for attending the Written Test/ Interview. The recruited project staff is eligible for leave as per rules and will have to give an undertaking before joining.

GENERAL CONDITIONS:
The conditions of employment will be the same as that of the project stall on contract basis. The candidates have no right to claim for any regular employment at this institute.

The appointing authority has the right to accept/ reject any application without assigning any rcason(s) and no correspondence in this matter will be entertained. Age, Qualification, experience etc., will be reckoned as on the date of walk-in-written lest interview. However the selection Committee reserves the right to reduce the experience in case of deserving candidates.

Note: No electronic device including Calculator and Mobile phones are allowed in the examination Hall.

Interested candidates for the various positions mentioned below are invited to appear tor the Walk-in-interview/Written Test along with 5 copies of their updated Bio data/ CV and supporting documents/ certificates on 24th June 2019 between 09:00 A.M to 10:00 A.M at Indian Council of Medical Research, Ansari Nagar, New Delhi-110 029. Late comers will not be entertained beyond 11:00 AM under any circumstances.