THSTI CDSA Clinical Research
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THSTI CDSA Clinical Research Associate Job For Life Sciences, Rs. 65,000 pm Pay

THSTI CDSA Clinical Research Associate Job For Life Sciences, Rs. 65,000 pm Pay. MSc Life Sciences Jobs. Clinical Research Associate Jobs. Interested and eligible applicants can check out all of the details on the same below

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CLINICAL DEVELOPMENT SERVICES AGENCY
An extra mural unit of THSTI,
An autonomous organization of Department of Biotechnology
Ministry of Science & Technology, Govt. of India
3rd Floor, THSTI Building, 3rd Milestone, Gurgaon-Faridabad Expressway,
Faridabad – 121001 (Haryana)

Recruitment Notice No. CDS/RN/15/2021

Name of the Post & No. – Clinical Research Associate– 1 positions

Name of the Study – Mission COVID Suraksha (NBM Project)

Duration – Till 31st January 2022 (To be extended as per the requirement of the Project)

Age Limit – Upto 40 years

Location – Faridabad or across any clinicalsite (in India).

GENERAL TERMS & CONDITIONS

  1. All educational professional and technical qualifications should be from a recognized
    Board/ University and full-time.
  2. The experience requirement specified should be experience acquired after obtaining
    the minimum educational qualifications required for the post.
  3. Persons working in Govt. or Public Sector undertaking should produce “No Objection
    Certificate” at the time of Interview.
  4. The qualification, experience and the number of positions and other requirements for
    the post can be relaxed at the discretion of the Chairman of the Interview Committee,
    in case candidates are otherwise well qualified.
  5. Only shortlisted candidates will be contacted for an interview.
  6. Incomplete applications will stand summarily rejected without assigning any reasons
  7. The salary is a consolidated sum as per sanctioned order without any other benefits.
    The salary mentioned against the position is the maximum and can be lesser based on
    the candidate’s experience, qualifications, skill set, etc. A 10% annual increase in salary is based on the performance
  8. This position is strictly project-based.
  9. This position may require 25% or more travel.
  10. All results will be published on our website and all future communications will be only
    through email
  11. Candidates(Including SC/ST and other backward classes) are not entitled forthe travel
    reimbursement or any other reimbursement for attending the interview.
  12. This position will be placed in the CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
  13. Canvassing in any form will be a disqualification.
  14. Submission of application will be thru online mode only otherwise it will get rejected or ignored.

Procedure for filling online application

a. Before filling up the online application, keep the following documents handy:
i) A soft copy of your passport size photo and signature. (only jpeg/jpg format,
file size 50 kb maximum)
ii) A comprehensive CV (PDF format only, file size 1 MB maximum) containing details of qualification, positions held, professional experience/distinctions etc.
iii) Candidates are requested to use the Google Chrome internet browser for the best results in the submission of online applications.
b. Once the online application is submitted, no correction/ modification is possible.
c. In case of difficulty in filling up the online form, please send an e-mail to
[email protected].
d. Those who have applied once need not apply again.
e. Only technical queries will be resolved (if any), other than technical will not be entertained.
f. On successful submission of your application, an auto-generated email containing a reference number will be sent to the email address provided. Please keep a note of the reference number for future correspondence.

Emoluments – up-to Rs. 65,000/- per month consolidated

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 the contracted scope of work.
  • Performs quality functions and executes quality programs (clinical operations, clinical laboratory) as per GCP 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 trials 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 onto the CRFs is consistent with participant clinical notes (source data/ document verification); continuous central monitoring and ensuring the timely resolution of queries by the site team.
  • Writing visit reports and follow-up letters within timeline.
  • 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 Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required.

Qualifications and Experience

  • Bachelor’s in medical sciences or Master’s degree/ diploma, life sciences or another related discipline
  • At least 3 years of relevant clinical trial monitoring experience.

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

See Notification Below

APPLY ONLINE

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