Welcome Back

Google icon Sign in with Google
OR
I agree to abide by Pharmadaily Terms of Service and its Privacy Policy

Create Account

Google icon Sign up with Google
OR
By signing up, you agree to our Terms of Service and Privacy Policy
Instagram
youtube
Facebook

Clinical Research Associate

Parexel
Parexel
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.