Clinical Research Associate

Job Description

Responsibility 1- Off-site Monitoring • To undertake off-site visits during different phases of study period, As per study plan conduct Initial Site Visit to train and guide site personnel. • To inspect pre-requisite as per protocol and ensure site is ready for the study, undertake routine monitoring visits at predetermined frequency as per study guideline. 2-Communication & Documentation • To communicate for Feasibility Assessment Questionnaire and fetch necessary detail for review from potential sites. • To take follow-up on routine basis with off-site nodal/in-charge, prepare visit reports (Pre-study Qualification Report, Site Initiation Visit report, Site Monitoring Visit Report, Site Closeout Visit Report) as per frequency with update of study trials and submit for review. • To procure pre-requisite documents (like calibration reports, agreements, etc) fromsites and vendor at the time of study start up and during the study. •To provide various data formats (Logs and form, Source data temples, recruitment trackers, Feasibility questionnaire etc.) to off-site team and ensure capturing/recording of data as per same. 3-Audits & Compliance • To review study related documents generated during the study in accordance with various SoPs/Protocol/Regulatory requirements. • To train/guide/mentor off-site team on study protocol/Regulatory aspects (GCP, Root Cause Analysis, updated regulatory requirements etc.) periodically. • To respond/comply to queries raised by internal (QA/QC) and external (Sponsor/Regulatory) auditors. • Any other task assigned by reporting authority.