Suhel Kesar

Clinical Research Associate @Translational Health Science And Technology Institute

Faridabad, IN

The Study Monitor/ CRA conducts 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 the contracted scope of work.• Completes appropriate therapeutic, protocol, and clinical research training to perform job duties. • Setting up the trial sites such that each center has the trial materials, including the trial drug while ensuring all trial supplies are accounted for in the study. • 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 into the CRFs is consistent with participant clinical notes (source data/ document verification) • Writing monitoring visit reports. • Filing and collating trial documentation and reports.• Archiving trial documentation and correspondence. • Evaluate 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.

D.A.V. College, Jalandhar

Bsc in Biotechnology, Biology, General

CLINI INDIA

Advance Program in Clinical Research & Management

Jamia Millia Islamia

Postgraduate Diploma in Computer Applications , Computer Science

Jamia Hamdard

Master's degree, Biotechnology