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Clinical Research Associate

0-2 years
Not Disclosed
10 April 7, 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: Clinical Research Associate (CRA)

Company: Parexel
Location: Global/Multiple Locations (travel required)
Job Type: Full-Time


Job Overview

As a Clinical Research Associate (CRA) at Parexel, you will play a key role in ensuring patient safety and site compliance throughout the clinical trial process. You’ll serve as Parexel’s direct point of contact with investigator sites and manage site-level activities from initiation through close-out.


Key Responsibilities

Site Management (Initiation to Close-out):

  • Serve as Parexel's primary contact for assigned sites.

  • Monitor site performance, adherence to protocols, and compliance with ICH-GCP and regulations.

  • Identify, assess, and resolve site issues.

  • Conduct qualification, initiation, monitoring, and close-out visits.

  • Train site staff on study systems and procedures.

  • Ensure data accuracy and integrity through regular site visits and remote contacts.

  • Collect, review, and approve regulatory documentation.

  • Track and manage study supplies and test article accountability.

  • Oversee CRF data entry, query resolution, and SAE follow-ups.

  • Prepare and submit visit reports and documentation to the Trial Master File (TMF).

Project Contribution:

  • Maintain clinical trial management systems (CTMS, EDC, IVRS).

  • Ensure audit/inspection readiness at sites.

  • Collaborate with internal teams for efficient planning and goal completion.

  • Support document distribution and site file configuration.

  • Provide subject matter expertise and contribute to performance development.

  • Maintain a positive and collaborative team environment.


Skills & Competencies

  • Detail-oriented, organized, and self-motivated.

  • Effective communication and interpersonal skills.

  • Problem-solving ability and critical thinking.

  • Time management and ability to meet timelines.

  • Proficiency in CTMS, EDMS, and Microsoft Office Suite.

  • Able to travel extensively and hold a valid driver’s license (as needed).

  • Comfortable working in a virtual and matrix team environment.


Qualifications

  • Education:

    • Bachelor's degree in Biological Sciences, Pharmacy, Nursing, or a health-related field.

    • Equivalent nursing qualification or relevant clinical experience also considered.

  • Experience:

    • Prior site monitoring or equivalent clinical research experience.

    • Understanding of clinical trial methodology and terminology.


Additional Details

  • Must be willing and able to travel according to project requirements.

  • Expected to maintain high standards of quality, integrity, and patient safety.

  • Leadership potential and ability to work independently with limited oversight.