BRIC - Translational Health Science and Technology Institute (THSTI) is an autonomous Institute of the 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.
Quality Manager (01 Position)
Name of the Study : DTRC
Age : 45 years
Emoluments : Rs 80,000/-
Duration : 03 Months (June 2024) (can be extended further)
Essential qualification and work experience :
• Master’s Degree or PG Diploma in Life Sciences or Biomedical Sciences or Pharmacy or Public Health or Clinical Research.
• At least 4 years of demonstrated experience in clinical trial monitoring or clinical site management experience.
• GCP Certification.
Desirable :
• GCLP Certification or experience of monitoring of laboratory-based activities/ research.
• Two years of work experience in the area of Quality Control and Quality Assurance in clinical 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, provide 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 that 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 the Clinical Portfolio Management department and other internal departments on their requirements as and when required.
• Work with data management and other key departments (laboratory, etc.) to track the process, and progress, and to ascertain the foreseen challenges proactively
Skills :
• Good understanding of needs for projects 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, delegate, 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 all stakeholders.
• Ability to assess non-compliance situations and recognize the potential or real wider strategic risk to the project, escalate when needed.
• Ability to identify systematic causes of complex quality problems and recommend long-term solutions.
• Create fair and ethical culture that fosters high standards of ethics.
• Basic business computer skills (MS Word, Excel, e-mail).
Interested candidates fulfilling the criteria as mentioned for Quality Manager Post may walk-in for a written test/skill test/interview on 04th April @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)
Clinical Research Associate (01)
Name of the Project : DTRC
Emoluments : Rs. 55,000/-
Age : 35 Years
Duration : 03 Months (June 2024) (can be extended further)
Minimum Educational Qualification and Experience :
• Bachelor in Life Sciences with a minimum of three (3) years of relevant clinical trial monitoring or clinical site coordinator experience. OR
• Master’s degree/ PG diploma, life sciences, pharmacy, public health, healthcare, or other related disciplines with a minimum of two (2) years of relevant clinical trial monitoring or clinical site coordinator experience.
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred (Experience as above
Skills
• Basic knowledge and ability to apply GCP and applicable regulatory guidelines.
• Computer skills including proficiency in the use of Microsoft Office applications.
• 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 conducts 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 the contracted scope of work.
• Performs quality functions and executes 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 in the study.
• 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 into the CRFs is consistent with participant clinical notes (source data/ document verification)
• Writing monitoring visit reports.
• Filing and collating trial documentation and reports.
• Archiving trial documentation and correspondence.
• Evaluate 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 the Clinical Portfolio Management department on other projects as directed and with other internal departments on their requirements as and when required.
Interested candidates fulfilling the criteria as mentioned For Clinical Research Associate. May walk-in for written test/skill test/interview on 04th April 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.
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
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