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Senior Clinical Research Associate

3+ years
Not Disclosed
10 Sept. 18, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences 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

Senior Clinical Research Associate (SCRA)

Job Overview

We are seeking a Senior Clinical Research Associate to support clinical trials from feasibility through closeout. The role involves site management, regulatory compliance, project coordination, and communication with stakeholders to ensure successful trial conduct in alignment with ICH-GCP guidelines and SOPs.


Key Responsibilities

Project Setup & Feasibility

  • Conduct feasibility assessments for clinical trials.

  • Perform project setup activities, including site selection and initiation.

  • Negotiate and facilitate Investigator/site contract execution.

  • Develop and locally adapt study-specific documentation.

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

  • Facilitate regulatory submissions as required.

Project Conduct & Site Management

  • Conduct site initiation visits (SIVs) and site monitoring visits (SMVs).

  • Maintain ongoing communication with site study teams, clients, and vendors.

  • Resolve site-level issues and escalate to Project Manager (PM) as necessary.

  • Support PM/Project Team Lead (PTL) with project updates and reporting.

  • Prepare, conduct, and participate in Investigator meetings.

  • Perform CRF retrieval and query resolution/turnaround.

Project Closeout

  • Conduct site closeout visits and ensure proper documentation.

  • Support overall project closeout activities in alignment with SOPs.


Required Qualifications & Experience

  • Experience: Minimum 3 years of clinical trial monitoring experience.

  • Knowledge: Strong understanding of GCP principles and applicable local regulations.

  • Skills:

    • Excellent communication and interpersonal skills.

    • Strong organizational and problem-solving abilities.

    • Ability to work independently and in coordination with multi-functional teams.


Why Join

  • Participate in global clinical trials with structured processes and regulatory compliance.

  • Contribute to site management and trial success, ensuring patient safety and data integrity.

  • Work in a collaborative environment with opportunities for professional growth.