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Senior Clinical Associate

4-8 years
Not Disclosed
10 June 2, 2025
Job Description
Job Type: Full Time Education: B.Sc./M.Sc/B.Pharm/M.Pharm/Life Science Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

 

Job Title: Senior Clinical Associate

Experience Required: 4 – 8 years
Job Type: Full Time
Location: Satyamev
Department: Clinical Operations Department (COD)
Function: Clinical Research Associate


Functional Role:

CRA / Sr. CRA


Reporting To:

[To be filled by organization]


Primary Responsibilities:

1. Off-site Monitoring

  • Conduct off-site visits during different phases of the study as per the study plan.

  • Perform Initial Site Visits to train and guide site personnel.

  • Inspect protocol-based prerequisites and ensure site readiness.

  • Perform routine monitoring visits at pre-scheduled intervals as per study guidelines.

2. Communication & Documentation

  • Coordinate with potential sites for Feasibility Assessment Questionnaires.

  • Follow up with off-site nodal personnel regularly.

  • Prepare visit reports (Pre-study Qualification, Site Initiation, Site Monitoring, and Closeout) and submit them for review.

  • Procure necessary documents like calibration certificates, agreements, etc., during study start-up and conduct.

  • Distribute required templates (logs, forms, trackers, feasibility questionnaires) and ensure accurate data capture.

3. Audits & Compliance

  • Review study-related documents for compliance with SOPs, protocols, and regulatory guidelines.

  • Periodically train and mentor the off-site team on protocols and regulatory requirements, including GCP, root cause analysis, and updates.

  • Respond to and address findings from internal (QA/QC) and external (Sponsor/Regulatory) audits.

4. Additional Duties

  • Perform any other tasks as assigned by the reporting authority.


Prepared By (Reporting Manager):

Name: [To be filled]
Designation: [To be filled]
Signature: ____________
Date: ____________


Reviewed By (Department Head):

Name: [To be filled]
Designation: [To be filled]
Signature: ____________
Date: ____________