Position - CRA (Clinical Research Associate)
Department- Clinical Operations Department
Experience - 5 to 8 Years
Salary Range - 5 LPA to 10 LPA
Location - Ahmedabad
Open Positions - 06
Roles and Responsibilities:
1- Off-site Monitoring
• To undertake off-site visits during different phases of the study period, As per
Study plan conducts Initial Site Visit to train and guide site personnel.
• To inspect pre-requisites as per protocol and ensure the site is ready for the
study, undertake routine monitoring visits at a predetermined frequency as
per study guideline.
2-Communication & Documentation
• To communicate for the Feasibility Assessment Questionnaire and fetch
necessary detail for review from potential sites.
• To take follow-up on a routine basis with the 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 the update of study trials and submission for review.
• To procure pre-requisite documents (like calibration reports, agreements,
etc) from sites and vendors at the time of study start-up and during the study.
•To provide various data formats (Logs and form, Source data templates,
recruitment trackers, Feasibility questionnaire, etc.) to the off-site team and
ensure the capturing/recording of data as per the same.
3-Audits & Compliance
• To review study-related documents generated during the study in
accordance with various SoPs/protocols/Regulatory requirements.
• To train/guide/mentor the off-site team on study protocol/Regulatory aspects
(GCP, Root Cause Analysis, updated regulatory requirements, etc.)
periodically.
• To respond to/comply with queries raised by internal (QA/QC) and external
(Sponsor/Regulatory) auditors.
• Any other task assigned by the reporting authority.
Interested Candidates can share their resumes at Vaibhav.D3662@veedalifesciences.com or on 6359600877.
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