Clinical Research Associate

7 days ago

Ahmedabad, Gujarat, India Veeda CR Full time ₹ 9,00,000 - ₹ 12,00,000 per year

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.

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