Clinical Research Associate

Role & responsibilities

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.

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) from sites 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.

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.