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Senior Clinical Research Associate

3+ years
Not Disclosed
10 May 28, 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 Research Associate


Job Overview

We are currently seeking a Senior Clinical Research Associate (SCRA) to join our growing team. The role involves end-to-end clinical trial management support, site monitoring, and regulatory compliance according to ICH E6 guidelines and internal SOPs.


Key Responsibilities

Start-Up Activities

  • Conduct feasibility assessments and site selection

  • Participate in project set-up activities

  • Facilitate investigator and site contract negotiation and execution

  • Develop and locally adapt study-specific documentation

  • Set up and maintain the Trial Master File (TMF)

  • Facilitate regulatory submissions

Study Conduct

  • Prepare, conduct, and participate in Investigator meetings

  • Conduct site initiation and routine monitoring visits

  • Ensure continuous communication with study sites and teams

  • Act as a back-up for Project Manager or Project Team Lead as needed

  • Support resolution of site-level issues and escalate when necessary

  • Assist Project Manager/Team Lead with study updates and client communication

  • Retrieve Case Report Forms (CRFs) and manage query resolution

Study Closeout

  • Conduct site closeout visits

  • Oversee project closeout activities


Required Experience & Qualifications

  • Minimum 3 years of independent monitoring experience in clinical trials

  • Strong knowledge of Good Clinical Practice (GCP) and applicable local regulatory requirements