Job for Clinical Research Associate in Preterm Birth Program at CDSA - Government Job | 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 : CRA (Preterm Birth Program) 

Emoluments : Rs. 40,000/- per month

Duration : 6 Months

Job profile
The Study Monitor/ CRA conduct monitoring visits for assigned study protocol and study sites. Overall responsibilities are to ensure that the study is being conducted in accordance with the protocol, standard operating procedures, good clinical practice, and applicable regulatory requirements.
• Performs site monitoring throughout the trial whichinvolves visiting the trial sites on a regular basis (siteinitiation to site closeout) in accordance with contractedscope of work
• Performs quality functions and executing quality programs(clinical operations, clinical laboratory)
• Completes appropriate therapeutic, protocol and clinicalresearch training to perform job duties.
• Setting up the trial sites such that each centre has the trialmaterials, including the trial drug while ensuring all trialsupplies are accounted for
• Administers protocol and related study training to assignedsites and establishes regular lines of communication withsites to manage ongoing project expectations and issues.
• May provide training and assistance to junior clinical staff
• Creates and maintains appropriate documentationregarding site management, monitoring visit findings andaction plans by submitting regular visit reports and otherrequired study documentation.
• Manages the progress of assigned studies by trackingregulatory/ IEC submissions and approvals, recruitmentand enrolment, CRF completion and submission, and dataquery generation and resolution.
• Verifying that data entered on to the CRFs is consistentwith patient clinical notes (source data/ documentverification)
• Writing visit reports
• Filing and collating trial documentation and reports.
• Archiving study documentation and correspondence
• Evaluates the quality and integrity of study 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, pharmacy, public health, healthcare or other related discipline
• MBBS/ BDS/ BHMS/ BAMS/ BPT preferred
• At least 3-5 years of relevant clinical trial/ study 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.

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