CDSA Recruitment 2021
CDSA Recruitment 2021 CLINICAL DEVELOPMENT SERVICES AGENCY (CDSA) 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) intends to engage eligible candidate for Clinical Research Associate post. Details are given below.
Recruitment Notice No. CDS/RN/10/2021
Name & No. of the Post : 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 : 12 Months, extension of contract is based on the performance.
Age Limit: Up to 45 Years
Location : Faridabad or across any clinical site (in India).
Qualifications and Experience:
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred
• 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
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.
• 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
Mode of Application: Online.
LAST DATE OF APPLICATION: 31.07.2021
NOTE:
THIS IS A ROLLING OUT ADVERTISEMENT ON CDSA WEBSITE ONLY. THE APPLICATION WILL BE SCREENED ON WEEKLY BASIS. IN CASE A SUITABLE CANDIDATE IS NOT FOUND, THE CALL FOR APPLICATION WILL REMAIN OPEN TILL SUITABLE CANDIDATE IS FOUND. AS SOON AS SUITABLE
CANDIDATE IS FOUND, THIS RECRUITMENT NOTICE WILL BE CLOSED ON OUR WEBSITE.
For Details:
Official Notification: CDSA RECRUITMENT
Official Website: https://thsti.res.in/cdsa/
To Apply Online: CLICK HERE
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