Job description
Role & responsibilities
Off-site Monitoring:
1-Conduct off-site visits during different study phases, including initial site visits to train and guide site personnel.
2-Ensure the site is ready for the study by inspecting pre-requisites as per the study protocol.
3-Undertake routine monitoring visits at predetermined frequencies as per study guidelines.
Communication & Documentation:
1-Manage Feasibility Assessment Questionnaire (FAQ) and collect necessary information for review from potential sites.
2-Perform regular follow-ups with off-site nodal/in-charge personnel and prepare visit reports such as:
a-Pre-study Qualification Report
b-Site Initiation Visit Report
c-Site Monitoring Visit Report
d-Site Closeout Visit Report
3-Submit reports for review in a timely manner, updating on study trials.
Audits & Compliance:
1-Review study-related documents to ensure compliance with SoPs, protocol, and regulatory requirements.
2-Train, guide, and mentor the off-site team on study protocol and regulatory aspects (GCP, Root Cause Analysis, updated regulatory requirements).
3-Respond to and comply with queries raised by internal (QA/QC) and external (Sponsor/Regulatory) auditors.