THSTI Recruitment Notification 2023; Clinical Research Associate, Research scientist & more

• Research Scientist (Bioinformatics)
• Consultant Data Manager (POD) 

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 integral to the interdisciplinary NCR Biotech Science Cluster at Faridabad. It 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.

This recruitment is to fill the vacancies for project positions at Clinical Development Services Agency (CDSA) centre. CDSA is a niche center of THSTI established to facilitate the development of affordable healthcare products for public health diseases.

Research Scientist (Bioinformatics)

Sl. no: 2

Emoluments : Rs. 1,10,000/-

Age: 40 years

Duration: One Year

Minimum Educational Qualification and Experience :

Essential qualification and work experience: MD or MVSc or M.Tech with a minimum of 2 years relevant post-qualification research experience OR PhD in Life Sciences / Computational Science / Bioinformatics / Genomics from a recognized University with a minimum of 6 months relevant post-qualification research experience.

Desirable: Work experience in metagenomics and bacterial genomics.

Consultant Data Manager (POD) 

Sl. no : 3

Number of posts: One

Emoluments : Rs. 75,000/-

Age: 45 years

Duration: Dec 2023

Minimum Educational Qualification and Experience: Educated to Graduation degree level in the healthcare field, IT, Computer Applications with 4 years experience in clinical data management and data analysis OR Master’s degree in the healthcare field, IT, Computer Science, Computer Applications with 2 years experience in clinical data management and data analysis

Job profile 

• Providing data management services for the project
• Providing exploratory data analysis support as per the requirement of the group
• Providing technical support to the consortium
• Working knowledge of Query management, data cleaning, data freezing and data archival. Sound knowledge of Clinical Database Development tools, logic and techniques and GCDMP
• Working knowledge of database standard
• Providing data management services for the project
• Providing exploratory data analysis support as per the requirement of the group
• Providing technical support to the consortium.
• Working knowledge of Query management, data cleaning, data freezing and data archival. Sound knowledge of Clinical Database Development tools, logic and techniques and GCDMP
• Working knowledge of database standard

Skills: – 

• IT literate (experience with Microsoft-based applications and other CDMS applications)
• Must have experience in handling EDC tools
• Demonstrated knowledge of validation programming. Demonstrated knowledge of query management and data cleaning
• Must understand clinical trials and familiarity with clinical data management functions.
• Good interpersonal, verbal and written communication skills.
• Client-focused approach to work.
• A flexible attitude concerning work assignments and new learning.
• Meticulous attention to detail. Effective time management in order to meet team objectives.
• Commitment to project and team goals.
• Must be able to work independently but seek guidance when necessary.
• Team player with outstanding interpersonal, negotiation skills and organizational skills.
• Sense of urgency in completing assigned tasks
• Exhibits a sense of urgency about solving problems and completing work.
• Shows commitment to and consistently performs high-quality work. Ability to model behaviors and ethics per CDSA’s Mission and Vision.

Clinical Research Associate 

Sl. no: 4

Number of posts: One

Emoluments : Rs. 55,000/-

Age: 35 Years

Duration: One Year

Minimum Educational Qualification and Experience

• Bachelor’s in medical sciences with at least three years of relevant clinical trial monitoring experience. OR
• Master’s degree/ diploma, life sciences, pharmacy, public health, healthcare or another related discipline with minimum 2 years of relevant clinical trial monitoring experience.
• MBBS / BDS / BHMS / BAMS / BPT preferred

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 following the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.

• Performs site monitoring throughout the trial, which involves visiting the trial sites regularly (site initiation to site closeout) following 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 centre 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 into 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 senior management.
• Work with Clinical Portfolio Management on other projects as directed and with other internal departments on their requirements as and when required.

Skills: –

• Computer skills, including proficiency in the 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

Head Regulatory Science and Medical Affairs

Sl. no: 1

Emoluments : Rs. 1,65,000/-

Age: 55 years

Duration: One Year

Minimum Educational Qualification and Experience: Medical professional qualification (MD OR MBBS or equivalent qualification) from a recognized university with at least 08 years of work experience in clinical research, especially in clinical operations (start-up activities), regulatory function, medical affairs including medical monitoring, medical writing, pharmacovigilance and medical coding and systems for adverse event review and reporting, safety reporting and management

Job profile 

Lead the medical and regulatory aspects of clinical trials/studies. Overall responsibility for leading the team in developing the protocol, study design, regulatory pathway, medical affairs and safety reporting. Serve as medical liaison to all stakeholders – funding agencies, investigators, and project teams.

Leadership and Strategy :

• Provide leadership on clinical trials and clinical study projects’ medical and regulatory aspects.
• Participate in business development activities
• Contribute to drafting policies and standard operating procedures
• Contribute to developing the clinical trials/studies portfolio
• Act as a key advisor on regulatory matters, writing position papers, and advising on “higher risk” studies.
• Responsible for dissemination of information for CDSA staff on all CDSCO/ ICMR Clinical Trials Regulation and its implications, regulatory requirements, research governance and Good Clinical Practice (GCP)
• Serve as a liaison for medical and regulatory functions to all stakeholders – funding agencies, sponsors, investigators, and project teams and provides medical and regulatory guidance throughout the life cycle of trials/studies.
• Provide guidance and oversees safety management, medical monitoring/coding and medical writing functions.
• Responsible for start-up activities, including regulatory submission dossiers, wherever applicable, and managing the regulatory compliance of the clinical studies.
• With the Administrative Manager and Chief of Clinical Portfolio Management, oversee and draft Memorandum of Understanding (MoUs) or other documents to outline the delegation of duties from the sponsoring office to CDSA and other stakeholders of the projects.

Medical Affairs (50%)

• Provide leadership to clinical trial and clinical study projects on medical and safety aspects.
• Participate in clinical review meetings and document preparation for meetings as required
• Guide the project teams in the preparation and review of study documents like

• Review all documents assigned for scientific/ medically relevant issues, including drug safety
• Review and sign off technical documents written concerning medically relevant matters, with particular attention to those relating to drug safety
• DSMB: Develop/ review DSMB charter, support constitution of DSMB for clinical trials, organize and coordinate DSMB meetings
• Provide input as necessary to Feasibility Studies, Data and Safety Monitoring Committees (DSMC) and other committees, clinical/ product development planning meetings
• Act as medical liaison with clients and solicit expert advice, develop a collaborative relationship with key experts and investigators
• Assist in the preparation of client proposals
• Oversee the medical monitoring and medical coding function for all the clinical studies in which CDSA is involved.
• Train/mentor and provide leadership to the medical monitor(s) and coders assigned to the clinical studies/trials
• Oversee and ensure accurate interpretation of single and or grouped adverse events, serious adverse events, drug effect and attribution of causality, and disease condition
• Oversight/review of clinical narrative reports prepared by the Investigators describing the event; advise on individual participant cases as identified by the study team and identifying queries for the local monitors to complete.
• Ensure compliance with clinical safety and good pharmacovigilance practices and requirements
• Review and provide support in finalizing Periodic Safety Update Reports (PSURs)
• Review and edit CSR for clinical consistency with data and Standard of practice
• Review and sign off Data Management listings of safety data (including adverse events, laboratory data, vital signs data, medical history, physical examination, concomitant medication),
• Assist the PI and DSM in establishing the presence or absence of clinically meaningful trends and, if noted, assisting in follow-up as appropriate with the project team, sponsor, and Regulatory Authorities
• Review and provide input for AEs (coded), past medical history, concomitant medications or other medical data listings to verify and medically vet clinical data.
• • Provide consulting services to assist in developing new drugs or devices under the direction of the Head of the Organization. Regulatory Science (40%)
• Act as regulatory lead to projects by coordinating regulatory workflow for DCGI and Institutional Ethics Committee submission and approvals, ensuring sufficient regulatory project coverage, and providing regulatory support to the team.
• Review and approve investigator site regulatory package documents (Statement of Investigator, investigator CVs, IRB/IEC approval documentation, consent forms, etc.). Work with the appropriate project team members to resolve queries.
• Maintain a working knowledge of, and assure compliance with applicable ICH & CDSCO Guidelines, Regulatory Agency requirements, and CDSA SOPs

GENERAL TERMS & CONDITIONS

• The positions will be hired initially for one year with a probation period of six months. The extension will be granted subject to the satisfactory performance of the incumbents and the tenure of the project for which they are selected. Those appointed to these positions will not have any claim for regularization of their employment.
• All educational, professional and technical qualifications should be from a recognized Board/University.
• The experience requirement specified above shall be the experience acquired after obtaining the minimum educational qualifications specified for the post.
• Closing date of the online application will be the CRUCIAL DATE for determining eligibility concerning age, essential qualification etc.
• The 05 number of positions to be hired, 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. Suppose candidates need to be found suitable for the posts notified. In that case, they can be offered lower costs / lower emoluments on the recommendation of the Selection Committee.

Age and other relaxations for direct recruits and departmental candidates:

1. By five years for 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

4. Age is relaxable for Central Government servants up to five years by the instructions or orders issued by the Central Government occasionally.

5. There is no upper age limit for the Institute employees treated as departmental candidates.

g) All results will be published on our website, and all future communications will be only through email

h) In case many applications are received, the screening will be done to limit the number of candidates to those possessing higher/relevant qualifications and experience.

i) About any provisions not covered in this notification, the bye-laws of THSTI / Govt. of India rules/guidelines shall prevail.

j) Canvassing wrong in any form will be a disqualification.

k) The candidate may be transferred to the site location per the project requirement and management discretion.

HOW TO APPLY

1. Documents to be kept handy before filling up the online application: (all the documents except (i) should be in pdf format):

i) A soft copy of your passport-size photo and signature. (jpeg/jpg/png format)

ii) A comprehensive CV containing qualifications, positions, professional experience/distinctions etc.

iii) Matriculation certificate (equivalent to 10th Standard) / Mark sheet iv) Intermediate certificate (equivalent to 12th Standard) / Mark sheet

v) Graduation/Diploma degree certificate / Mark sheet vi) Post-Graduation degree certificate & Mark sheet (if applicable)

vii) PhD/MD Degree (if applicable)

viii) Relevant experience certificates (if applicable) ix) Caste / Disability certificate in the format prescribed by the Govt. of India, if applicable

Procedure for filling up online application

i) The eligible and interested candidates may apply online at the Institute’s website, www.thsti.res.in/career. Applications through any other mode will not be accepted. ii) The following will be the step-wise procedure-

A) Step 1: Details of the applicant

B) Step 2: Uploading of documents

C) Step 3: Payment of application fee

• The payment can be made using a Debit Card / Credit Card / Internet Banking /UPI.

• Once payment is made, no correction/modification is possible

• Candidates are requested to keep a copy of the provisional receipt for future reference.

• Fee, once paid, shall not be refunded under any circumstances.

• Details of fees to be paid are as shown below:

1. Unreserved, OBC & EWS candidates : Rs 590/-

2. SC/ST/Women/PwBD: Rs 118/-

D) Step 4: Submission of the application form.

iii) On successful application submission, an auto-generated email containing the reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence.

iv) Candidates must keep a printout of the online application form using the print button on the dashboard for future reference.

v) Candidates must ensure that he/she fulfil all the eligibility criteria stipulated in the advertisement. Suppose it is found that he/she does not fulfil the stipulated criteria during the recruitment process. In that case, the candidate’s candidature will be cancelled. If the same is noticed after the appointment, the candidate will be terminated following due process.

vi) Incomplete applications shall be summarily rejected, and no correspondence in this regard shall be entertained.

vii) In case of difficulty filling up the online form, please email [email protected] along with the screenshot of the error displayed (if any).

Last date of receipt of online application: 17th April 2023