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Opportunity for M.Pharm, MSc as CRA, Quality Manager at BRIC-THSTI


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Opportunity for M.Pharm, MSc as CRA, Quality Manager at BRIC-THSTI

BRIC - Translational Health Science and Technology Institute (THSTI) is an autonomous Institute ofthe 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, and is designed as a dynamic, interactive organization with the mission to conduct innovative translational research and to develop research collaborations across disciplines and professions to translate concepts into products to improve human health.

Post : Clinical Research Associate, Quality Manager

Clinical Research Associate (01)
Number of posts : DBT Neo-Sepsis
Emoluments : Rs. 60,760/-
Age : 35 Years
Duration : 01 Year
Minimum Educational Qualification and Experience :
• Bachelors in Life Sciences with minimum three years of relevant clinical trial monitoring experience. OR
• Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or other related discipline with minimum 2 years of relevant clinical trial monitoring experience.
• MBBS/ BDS/ BHMS/ BAMS/ BPT (Experience as above)
Computer skills including proficiency in 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.

Job profile
The Study Monitor/ CRA 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 executing quality programs (clinical operations, clinical laboratory) as per GCP/GCLP 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 on to the CRFs is consistent with participant clinical notes (source data/ document verification)
• Writing visit reports.
• 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.

Quality Manager (01 Position)
Name of the Study : DTRC
Age : 45 years (Flexible for exceptional Candidates)
Emoluments : Rs 80,000/-
Duration : 03 Months (June 2024) (can be extended further)
Minimum Educational Qualification and Experience : Essential qualification and work experience :
• Master’s degree in life sciences or biomedical sciences or pharmacy or Public Health or Clinical Research.
• At least 4 years of demonstrated experience in the area of Quality Control, Quality Assurance in biomedical research.
• GCP/ GCLP trained Desirable: Experience of monitoring of laboratory-based activities/ research.

Job profile
• Oversees quality management processes and provides guidance and support to project teams to meet quality standards.
• Actively lead or assist activities in the areas of Internal Quality improvements and CAPA (Corrective and Preventive Actions).
• Ensure that the assigned study is conducted in accordance with study protocols, GCP guidelines, and applicable regulatory requirements.
• Lead or assist with identifying non-conformances with requirements, provi suitable recommendations and facilitate ongoing quality improvements using a risk-based methodology.
• Proactively identify the project risks and assist in providing training to study staff in good clinical and documentation practices.
• Maintain GCP-compliant processes which control the quality of work at the study site
• Conduct source document verification and case record forms for assessing the study trends
• Develop quality monitoring plan and processes for clinical activities of data collection, laboratory-based activities of sample processing and storage, and running of the biorepository.
• Overseeing and/or performing quality functions and executing quality programs (clinical operations, clinical laboratory, data management review)
• Collaborate with clinical and project management teams to ensure compliance with quality standards, timelines, and appropriate follow-up in areas of deficiency
• Coordinate expert monitoring visits/ audits as per project requirements.
• Work with Clinical Portfolio Management and other internal departments on their requirements as and when required
• Work with data management and other key departments (Laboratory) to track the process, and progress, and to ascertain the foreseen challenges proactively.

Skills :-
• Good understanding of needs for project and job responsibilities.
• Extensive knowledge of GCP/GLP, observational studies and appropriate regulations and guidelines.
• Ability to develop and implement clinical and laboratory monitoring plans, SOPs, database concepts, and formats
• Ability to build effective project teams, ability to motivate others, delegation, drive and timely/ quality decision making
• Operational skills including focus and commitment to quality management and problem solving
• Influencing skills including negotiation and teamwork.
• Effective communication skills to provide timely and accurate information to stakeholders
• Ability to assess non-compliance situations and recognize potential or real wider strategic risk to project, escalates when needed.
• Ability to identify systematic causes of complex quality problems and recommend long-term solutions
• Fair and ethical. Creates a culture that fosters high standard of ethics.
• Basic business computer skills (MS Word, Excel, e-mail).

General Terms & Conditions
a) This is short-term positions and extension will be granted subject to satisfactory performance of the incumbents and tenure of the project for which they are selected. Those appointed to these positions will not have any claim for regularization of their employment.
b) All educational, professional and technical qualification should be from a recognized Board/University.
c) The experience requirement specified above shall be the experience acquired after obtaining the minimum educational qualifications specified for the post.
d) The age limit, qualification, experience and other requirements may be relaxed at the discretion of the competent authority, in case of candidates who are otherwise suitable. In case candidates are not found suitable for the posts notified, they can be offered lowerpost / lower emoluments on the recommendation of the Selection Committee.
e) Age and other relaxations for direct recruits and departmental candidates: 1. By five yearsfor candidates belonging to SC/ST communities. 2. By three years for candidates belonging to OBC communities. 3. For Persons with Benchmark Disabilities (PWBD) falling under the following categories: (i) UR - ten years, ii) OBC - 13 years (iii) SC/ST - 15 1. Age is relaxable for Central Government servants up to five years in accordance with the instructions or orders issued by the Central Government, from time-to-time. 5. Thereis no upper age limit for the Institute employees who are treated as departmental candidates. 6. For Ex- servicemen up to the extent of service rendered in defense forces (Army, Navy & Air force) plus 3 years provided they have put in a minimum of 6 months attested service.
f) All results will be published on our website and all future communications will be only through email.
g) In case a large number of applications are received, screening will be done to limit the number of candidates to those possessing higher/relevant qualification and experience.
h) With regard to any provisions not covered in this notification, the bye laws of THSTI / Govt. of India rules / guidelines shall prevail.
i) Canvassing in any form will be a disqualification.
j) You are requested to bring 2 passport size photograph & one set of photocopies of your education/qualification certificate/documents along with the originals at the time of interview

Interested candidates fulfilling the criteria as Clinical Research Associate for Sr. No. 1 Post may walk-in for a written test/skill test/interview on 19th March @10:30 AM for CRA at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001. (Note - The candidate must report by 09:30 AM to be interviewed otherwise the candidate will not be interviewed by the selection committee.

Interested candidates fulfilling the criteria as Quality Manager For Sr. No. 2. May walk-in for written test/skill test/interview on 19th March 2024 @02:30 PM at THSTI, NCR Biotech Science Cluster, 3rd Milestone, Faridabad-Gurugram Expressway, Faridabad – 121001. (Note - The candidate must report by 12:00 PM to be interviewed otherwise the candidate will not be interviewed by the selection committee).

Candidates can apply for both positions but they will have to appear for the interview separately
Note : Outstation candidates can send their request for an online interview through email: HR.CDSA@THSTI.RES.IN. one day prior to the interview with the updated CV/Qualification and experience certificate and name of the post. Their candidature will be subjected to the approval of the appropriate authority. The request of Delhi/NCR Candidates for online Interviews will not be entertained

Recruitment notice no.: THS-C/RN/03/2024

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