The India TB Research Consortium (ITRC) has been formed to fast-track and align efforts in TB research. ITRC aims to achieve this goal through an interdisciplinary collaborative approach by harnessing national and international expertise to advance technology as well as product development by delivering effective diagnostics, shorter drug regimens, efficacious vaccines alongwith newer interventions for TB control. A secratariat of the India TB Research Consortium has been set up at the Indian Council of Medical Research, New Delhi for initiating activities around the identified thematic areas and constituting of Working Groups for translating R&D leads to various products and interventions.
Following posts are to be filled purely on contractual basis for working under its various projects under India TB Research consortium (ITRC), under Division of Epidemiology and Communicable Diseases (ECD) ICMR Hqrs, New Delhi.
Project Scientist Support-V (Clinical Operations) (For ITRC) - 01 post
Essential Qualifications : 1st Class Master Degree in Biotechnology / Clinical Pharmacology / M.Pharm / life sciences or any equivalent degree from a recognized university with 4 years’ experience in CRO industry / Pharma / Biotech / Public Health / clinical research. OR
• 2nd Class M.Sc. / M.Pharm or any equivalent degree + PhD degree in Biotechnology / Pharmacology / M.Pharm Life sciences from a recognized university with 2 years’ experience in Pharma /Biotech/CRO industry / Public Health / Clinical research.
Desirable Qualifications : Ph.D. with at least 2 years post Doc experience in biomedical subject particularly in health research related areas. Working experience in scholarly publications.
ii. Knowledge of computer applications or business intelligence tools/data management/data synthesis/Report writing, data mining, writing articles/ working on databases. iii. Knowledge of New Drug and Clinical Trial Rules 2019 (Schedule Y), GCP, ICH guidelines and regulatory requirements for clinical trial conduct
Nature of duties
a. Protocol writing, Monitor the clinical trial including safety data and ensure timely completion of targets
b. Source data verification, Monitoring vaccine trial, monitoring e CRFs data entry and query resolution.
c. Review and submit SAE and update SAE document repository
d. Prepare patient tracker to ensure compliance and minimize missing visits
e. Monitor site performance for project targets, and project staff for patient compliance f. Monitor conduct of processes contributing to the performance of a clinical trial.
g. Prepare annual reports of projects and quality trending reports. h. Prepare weekly site wise and consolidated site report regarding enrollment /FU data for targets vs achievement. i. Keep upto date with all quality and compliance issues for quality levels of the staff, systems and production activities.
j. Any other job assigned by the PI or Programme officer Job requires frequent All India travel to sites for monitoring, quality assurance and quality management for at least 15 days a month.
Consolidated emoluments (per month) : Rs. 57,660/- Fixed per month
Max age limit : Upper age limit for up to 40 Years Age relaxation will be as per the Government of India/ICMR rules
Sr. Project Manager (vaccine Trial) - 01 post
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 with 10 years of research experience including demonstrated 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 7 years of post Ph.D experience with demonstrated core experience in managing / monitoring of regulatory clinical trials specially Vaccine/drug trial from reputed Institutions.
Consolidated emoluments (per month) : 1,00,000/- fixed per month
Max age limit : Upper age limit for up to 60 years Age relaxation will be as per the Government of India/ICMR rules
Consultant (Clinical Research Associate) - 02 posts
Essential Qualifications : Essential: 1st Class Master Degree in Life sciences / Biotechnology / Bio-Medical sciences / M.Pharm or any equivalent degree from a recognized university with 4 years’ experience or BAMS/BHMS/BDS/BV.Sc or any equivalent degree from a recognized university with 5 years’ experience in clinical research Or 2nd Class Master’s Degree in Life sciences/Biotechnology or any equivalent degree + PhD degree in relevant subjects from a recognized university with 4 years’ experience in clinical research. Desirable: i. Ph.D. with 2 years post- Doctoral experience in biomedical subject particularly in health research related areas. Working experience in clinical trials/Quality Control/Assurance/medical writing ii. Knowledge of computer applications or business intelligence tools/data management/data synthesis/Report writing, data mining, working on databases. Thorough knowledge of GCP, ICH guidelines and regulatory requirements for clinical trial conduct.
Consolidated emoluments (per month) : 60,000/- Fixed Per month
Max age limit : Upper age limit for up to 55 years Age relaxation will be as per the Government of India/ICMR rules
Part Time consultant (QA and GCP Expert) - 01 post
Essential Qualifications : 1st Class Masters in Biochemistry with certified GCP certificates with 10-15 yrs. experience in clinical research including Quality Assurance with experience in national and international audit of clinical research/clinical trials/vaccine trials and medical devices and experience of GLP animal toxicity
Desirable Qualifications : i. Experience of heading the QA projects, establishing SOPs at sites/lab. Experience of QA at domestic or international CRO
ii. Knowledge of computers,
iii. Knowledge of New Drug and Clinical Trial Rules 2019 (Schedule Y), GCP, ICH guidelines and regulatory requirements for clinical trial conduct
Nature of duties
a. Assist and provide mentorship in set up and assess compliance of Quality Management Systems framework at ITRC for the planned clinical trials as necessary for clinical research (a prerequisite for conducting regulated clinical trials to meet and exceed national & international standards).: Sponsors obligation
b. Review of Standard Operating Procedures (SOPs) for various functions of ITRC (vaccines and therapeutics) and associated documentation,
c. Assist in identifying necessary training programs for the sponsor and site team as required by ICH GCP to enhance/ensure competence.
d. Provide inputs in development of CT documents essentially regulatory writing such as trial protocol, case record forms, informed consent. Provide guidance on newer projects with relation to GCP framework.
e. Assist in assessing (remotely) the readiness of the clinical safety lab and immunogenicity labs for the planned trials through document reviews: GCP and GCLP mentorship.
f. Provide inputs to QA resource in developing ‘Risk based auditing plan for the trials
g. Analyse trends of the observations at current trial sites to assist in developing strategy for capacity building.
h. Review of other essential documents and Trial Master File (TMF)
i. Represent ITRC for any QA related matter as an advisor.
k. Promote the culture of quality through mentoring and coaching while advocating the GCP & GCLP compliance to meet trial and organizational objectives.
k. Will be required to visit ICMR Hq. for discussion, mentoring, examining trial related documents as and when required or minimum once a week. Rest of the days devoted 1-2 hours per day with the team and the work can be discussed and monitored virtually.
Note : Any site audits/vendor visits/trial related auditing shall be additional as per separate service agreement or payment terms.)
Consolidated emoluments (per month) : Rs. 50000/- per month
Max age limit : Upper age limit for up to 60 Years Age relaxation will be as per the Government of India/ICMR rules
General Terms and conditions
1. Number of positions may vary.
2. These positions are meant for temporary projects and co-terminus with the project.
3. Engagement of the above advertised Project Human Resource Positions will depend upon availability of funds, functional requirements and approval of the Competent Authority. Therefore, we are not committed to fill up all the advertised Project Human Resource Positions and the process is liable to be withdrawn / cancelled / modified at any time. 4. The rates of emoluments/stipend shown in this advertisement are project specific and may vary according to sanction of the funding agency of the Project. 5. Cut-off date for age limit will be as on the date of last date for submission of applications.
6. Age relaxation will be as per the guidelines of ICMR.
7. Reserved category candidates must produce their latest Caste Validity Certificate. OBC candidates must possess a latest valid non-creamy layer certificate. PWD candidates shall produce latest disability certificate issued by a Medical board of Government hospital with not less than 40% disability.
8. Separate application should be submitted for each position. Allotment of project to the successful candidates will be decided by the competent authority at its discretion. 9. Qualification & experience should be in relevant discipline/field and from an Institution of repute. Experience should have been gained after acquiring the minimum essential qualification. 10. Mere fulfilling the essential qualification does not guarantee the selection.
11. Persons already in regular time scale service under any Government Department / Organizations are not eligible to apply.
12. No TA/DA will be paid to attend interview / personal discussion and candidates have to arrange transport/accommodation themselves.
13. ICMR reserves rights to consider or reject any application/candidature.
14. Submission of wrong or false information during the process of selection shall disqualify the candidature at any stage.
15. The persons engaged on Project Human Resource Positions cannot be permitted to register for Ph.D., due to time constraints.
16. The persons engaged on Project Human Resource Positions will normally be posted at the study site; however, they can be posted to any other sites in the interest of research work. They are liable to serve in any part of the country.
17. The persons engaged on Project Human Resource Positions shall not have any claim on a regular post in ICMR or in any of its Institutes/Centers or in any Department of Government of India and their project term with breaks or without breaks in any or multiple projects will not confer any right for further assignment or transfer to any other project or appointment/absorption/regularization of service in funding agency or in ICMR. Benefits of Provident Fund, Pension Scheme, Leave Travel Concession, Medical claim, Staff Quarters . and other facilities applicable to the regular staff of ICMR etc. are not admissible to the project human resource positions.
18. Successful candidates will normally be engaged on Project Human Resource Position initially for a period of one year or less, depending upon the tenure of the Project and functional requirements. Continuation / Extension to engagement of Project Human Resource Positions will be depending upon evaluation of performance, tenure of the project, availability of funds, functional requirements and approval of Competent Authority. The maximum term of any Project Human Resource Position in any or multiple projects, with breaks or without breaks shall be five years only. The concerned Project Investigator, Division Head and Head of the host Institute shall personally be responsible and accountable for the continuation / extension given if any without prior concurrence of the Director General, ICMR to any project human resource position beyond five years either with or without breaks in any or multiple projects.
19. ICMR reserves the right to terminate the project human resource position even during the agreed contract period or extended contract period without assigning any reason.
20. Leave shall be as per the ICMR’s policy for project human resource positions.
21. Candidate must submit his/her duly filled in application form in the prescribed format with a recent passport size color photograph along with a detailed bio-data/C.V. and all relevant documents; duly self-attested; in proof of his/her educational qualifications [all certificates and mark-sheets from 10th Std. onwards], working experience, age, caste and photo id [Aadhar Card/Indian Passport/PAN Card/Driving License] etc., within the schedule date and time for submission of application, failing which his/her candidature will not be considered. Late/Delayed/Incomplete/Unsigned applications will not be considered at all and no correspondence will be entertained in this regard.
22. ICMR reserves the right to cancel/modify the process at any time, at its discretion. 23. The decision of the Competent Authority will be final and binding.
24. Canvassing in any form will be a disqualification.
25. Corrigendum/addendum/further information; if any; in respect of this advertisement, will be published on our website only. Hence, the candidates are advised to see the website of ICMR regularly for further updates related to this advertisement.
All the Deserving candidates who wish to appear for the interview should report on 16/11/2022 along with 5 copies of their Bio-data. The candidates must reach on 16/11/2022 at 8.30 AM till 10:30 AM for registration in ICMR-HQ. The verification of the documents of the candidate will start from 8:30 AM onwards and eligible candidates after verification would be interviewed 10:30 AM onwards.
Candidates applying for more than one post should indicate the names of the post clearly on application form. Applicants coming after 11.00 AM on 16th November 2022 will not be entertained
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