THSTI-CDSA Pharma Job Opening – Clinical Research Associate
THSTI-CDSA Pharma Clinical Research Associate With Rs. 55,000 pm Salary. MSc Govt M Pharma jobs at CDSA-THSTI with high pay. CDSA Pharmacy Job. Interested candidate check out all the details on the same below:
Name of the Post & No. Clinical Research Associate– 1 position
Name of the Study (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 )
Emoluments (up to Rs. 55,000/- per month consolidated)
Duration For 2-12 Months
Age Limit Up to 45 Years
Location Faridabad or across any clinical site (in India).
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 and regulations
- Completes appropriate therapeutic, protocol and clinical research training to perform job duties.
- THSTI-CDSA Pharma Job 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 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
Qualifications and Experience THSTI-CDSA Pharma Job
- Bachelor’s in medical sciences or Master’s degree/ diploma pharmacy, public health, healthcare or other related disciplines
- At least 2 years of relevant clinical trial monitoring
Experience & Skills
- 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
GENERAL TERMS & CONDITIONS:
1. All educational professional and technical qualification 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 position 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 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. Salary mentioned against the position is the maximum and can be
lesser based on candidate’s experience, qualifications, skill set, etc. A 10%
the annual increase in salary is based on the performance
8. This position is strictly project-based.
9. All results will be published on our website and all future communications will
be only through email
10. Candidates (Including SC/ST and other backward classes) are not entitled for
the travel reimbursement or any other reimbursement for attending the
interview.
11. This position will be placed in CDSA Faridabad office at NCR Biotech Science
Cluster at Faridabad Gurgaon Expressway, Faridabad or National
Institute of Tuberculosis and Respiratory Diseases, Delhi.
12. Canvassing in any form will be a disqualification.
13. 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) The documents in support of educational qualification and experience (PDF
format only, file size 1 mb maximum) as mentioned below:
- Matriculation Mark sheet
- Intermediate Mark sheet
- Graduation Degree/Mark Sheet
- Post-Graduation Degree/Mark Sheet
- Ph.D degree
- Relevant experience certificates
- Caste certificate in the format prescribed by the Govt. of India, if applicable
- Disability certificate in the format prescribed by the Govt. of India, if applicable
- List of Publications (if any)
- List of patents (if any)
b.Candidates are requested to use Google Chrome internet browser for best
results in submission of online application.
c. Once the online application is submitted, no correction/ modification is possible.
d. In case of difficulty in filling up the online form, please send an e-mail to
[email protected]
e. Those who have applied once need not to apply again.
f. Only technical queries will be resolved (if any), other than technical will not be entertained.
g. 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
Last Date To Apply: 11th June 2020
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