Senior Clinical Research Associate

Functional Role Reporting to

Department Location

We are specifically looking for mid-senior level professionals with the following experience:

• 100+ Site Monitoring Visits
• 30+ Site Initiation Visits (SIV)
• 30+ Close-out Site Visits (CSV)
• 25+ Pre-Qualification Visits
• Relevant exposure in

  Clinical Trials (CT)

  and

  (PK)

  studies

Responsibility

Description

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.