Govt Job: Clinical Research Associate "A"

Job Profile
The Monitor/ CRA conduct monitoring visits for assigned study’s 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 which involves visiting the trial sites on a regular basis (site initiation to site closeout) in accordance with contracted scope of work
• 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 study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.
• Provide training and assistance to site staff.
• Creates and maintains appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study 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 patient clinical notes (source data/ document verification).
• Writing visit reports as per departmental Standard Operating Procedures.
• 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 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.

Interested candidates may please send their current CV with a recent photo and  cover letter indicating their motivation for the position applied for (150 words) and three references along with the attached datasheet and excel sheet posted in the website. E-mail should be submitted with subject line Application for the post of “Study Monitor/ Clinical Research Associate (GLSE Study)” to cdsa_admin@thsti.res.in.