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Clinical Research Associate

0-2 years
Not Disclosed
10 April 3, 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

 


Clinical Research Associate

Company: Parexel
Location: Bengaluru, India
Job Type: Full-time

About Parexel

Parexel is a leading global clinical research organization (CRO) dedicated to accelerating drug development and ensuring patient safety. As a Clinical Research Associate (CRA), you'll play a vital role in monitoring clinical trials, ensuring regulatory compliance, and maintaining site relationships.


Job Summary

The Clinical Research Associate (CRA) at Parexel is responsible for site monitoring, regulatory compliance, and ensuring patient safety throughout clinical trials. This role involves traveling to investigator sites, managing site documentation, resolving issues, and collaborating with site staff to ensure smooth trial operations.


Key Responsibilities

Site Monitoring & Study Management

  • Act as Parexel’s direct contact with assigned sites to ensure protocol adherence and study integrity.

  • Monitor site compliance with regulations (ICH-GCP, local, and international).

  • Resolve site issues related to training, documentation, and communication.

  • Evaluate site recruitment plans and provide strategies for improvement.

  • Conduct site visits (Qualification, Initiation, Monitoring, and Close-out visits).

  • Generate detailed visit/contact reports and track CRF data entry, query status, and SAEs.

Regulatory & Compliance Management

  • Ensure sites are audit and inspection ready.

  • Review and approve regulatory documents and study-specific training.

  • Ensure timely submission of study documents to the Trial Master File (TMF).

  • Monitor and manage test article/study supply accountability and return status.

Collaboration & Communication

  • Build and maintain relationships with investigators and site staff.

  • Participate in investigator meetings, audits, and regulatory inspections.

  • Work with cross-functional teams to meet project goals and optimize trial efficiency.

  • Keep managers informed of work progress, study issues, and risk mitigation strategies.


Skills & Competencies

Technical & Analytical Skills

  • Strong problem-solving skills with the ability to prioritize multiple tasks.

  • Knowledge of Clinical Trial Management Systems (CTMS), EDC, IVRS, and MS Office tools.

  • Attention to detail and ability to identify potential data quality issues.

Interpersonal & Soft Skills

  • Excellent communication (written & verbal) and presentation skills.

  • Self-motivated, proactive, and able to work independently.

  • Strong team player with a client-focused approach.

  • Ability to work effectively in a virtual, cross-cultural team environment.

  • Flexible with extensive travel requirements and ability to manage time effectively.


Qualifications & Experience

Education

  • Bachelor’s degree in life sciences, pharmacy, nursing, or a health-related discipline (or equivalent experience).

Experience

  • Previous site management or clinical research experience preferred.

  • Understanding of clinical trial methodology and terminology.

  • Valid driver’s license (if required for travel).


Why Join Parexel?

  • Work on global clinical trials across various therapeutic areas.

  • Opportunity to grow personally and professionally within a diverse and innovative team.

  • Be part of an organization that prioritizes patient safety and well-being.

  • Competitive career growth, training, and mentorship opportunities.


Apply Now

If you have the skills and passion to contribute to groundbreaking clinical research, apply today!