Recruitment Notice No. CDS/RN/12/2019
Last Date: 29th July, 2019
CLINICAL DEVELOPMENT SERVICES AGENCY
3rd Floor, THSTI Building, 3rd Milestone
Gurgaon-Faridabad Expressway,Faridabad–121001 (Haryana)
Clinical Development Services Agency (CDSA) is an extramural unit of Translational Health Science and Technology Institute (THSTI) and has been established as a not-for-profit society to provide cost affective, high quality preclinical and clinical product development support services to meet the country’s growing healthcare needs. It will tend enterprises; particularly SMEs involved in new technology innovation and facilitate translation of scientific know-how into viable products.
1.Name of the post- Medical Monitor (1)
Pay Scale- Upto Rs.90,000 per month
Name of the Study
(MM) ((A Phase III, Multicenter, Randomized, Double-blind, Three arm Placebo controlled Trial to Evaluate the Efficacy and Safety of two vaccines
in Preventing Tuberculosis (TB) in Healthy Household Contacts of Newly Diagnosed Sputum Positive Pulmonary TB Patients funded by ICMR in Six
States of India)
The roles & responsibilities of Medical Monitor (MM) are as follows but not limited to:
- The MM, in consultation with Medical Director and safety oversight committees, will provide safety review during the execution of the clinical trial as per the pre-defined and approved safety management plan. This oversight includes reviewing safety information and providing applicable recommendations.
- Interpretation of single and or grouped adverse events, serious adverse events, drug effect and attribution of causality, and disease condition
- Educating, training, and mentoring research teams in safety monitoring and reporting
- Conduct on-site medical monitoring visit and communicate the observations through detailed visit report
- Assist sponsor in preparation of expedited and periodic reports
- Review of clinical narrative reports describing the event and support in fimalization
- Participates in development of CRF, statistical analysis plan (SAP), DMC charter and other documents as required by the study.
- Participate in study management team meetings, DMC and technical review meetings, as required.
- Interact with investigative sites, address protocol/medical questions in consultation with sponsor medical monitor
- Perform review of data generated by data listings or statistical analyses.
- Review medical coding of safety data
GENERAL TERMS & CONDITIONS
- All educational professional and technical qualification should be from a recognized Board/ University and full-time.
- The experience requirement specified should be experience acquired after obtaining the minimum educational qualifications required for the post.
- Persons working in Govt. or Public Sector undertaking should produce “No Objection Certificate” at the time of Interview.
- The qualification, experience and the number of position and other requirements for the post can be relaxed at the discretion of the controlling authority, in case candidates are otherwise well qualified.
- Only shortlisted candidates will be contacted for further discussion
- Incomplete applications will stand summarily rejected without assigning any reasons.
- The salary is a consolidated sum as per sanctioned order without any other benefits. Salary mentioned against the position is an actual and will be based on experience, qualifications, skill set, etc. of the candidates.
- This position is strictly project-based and hired only for 2-12 months.
- All results will be published on our website and all future communications will be only through email
- Candidates (Including SC/ST and other backward classes) are not entitled for the travel reimbursement or any other reimbursement.
- This position will be placed in CDSA Faridabad office at NCR Biotech Science Cluster at Faridabad Gurgaon Expressway, Faridabad.
- Canvassing in any form will be a disqualification.
- Submission of application will be thru online mode only otherwise it will get rejected or ignored.
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