Career for Clinical Research Associate in iKMC Study at Clinical Development Services Agency | M.Pharm, M.Sc

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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.

Post : Clinical Research Associate (iKMC Study), 01 Position

Age Limit Upto 35 Years

Emoluments/ Duration : Rs. 45,000/- per month consolidated, 30 Months

Location NCR Biotech Science Cluster, Faridabad

Job profile
Overall responsibilities are to ensure that the study is conducted in accordance with study protocol, standard operating procedures, good clinical practices, and applicable guidelines.
1) Performs site monitoring as well as remote monitoring activities in accordance with contracted scope of work / clinical operations plan
2) Completes induction program including appropriate therapeutic, protocol and clinical research trainings to perform job duties.
3) Acts as communication channel while facilitating effective communication among investigators, CDSA and key stakeholders
4) Administers protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
5) Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation.
6) Verifying that data entered on to the CRFs is consistent with patient clinical notes (source data/ document verification).
7) Manages the progress of assigned studies by tracking regulatory/ IEC submissions and approvals, subject enrolment, protocol compliance, clinical data collection including CRF completion, and data query generation and resolution.
8) Archiving study documentation and correspondence
9) Ensure that study is conducted, recorded and reported as per protocol, guidelines and applicable regulations & help ensure quality and integrity of clinical data.
10) Escalates quality issues to the Quality manager / Trial Coordinator /senior management and work with study team for implementation of action plan for resolution of issues.
11) Work with Clinical Portfolio Management on other projects as directed and other internal departments on their requirements as and when required.

 

Qualifications and Experience
Medical /Allied bachelor’s degree or Master’s degree in life sciences/pharmacy/healthcare or other related discipline or diploma/ post graduate degree in Clinical Research
At least with 3 years of clinical operations /monitoring experience in clinical trials / research projects

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