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Clinical Research Associate

0-2 years
Not Disclosed
10 March 31, 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

Location: Bengaluru, India

Company: Parexel

Job Overview:
As a Clinical Research Associate (CRA) at Parexel, you will play a crucial role in ensuring the safety and well-being of patients while contributing to clinical research. You will be responsible for monitoring investigator sites, ensuring study compliance, and maintaining data integrity throughout the clinical trial process.

Key Responsibilities:

Study Maintenance (Initiation to Close-out):

  • Act as the primary contact for assigned sites, ensuring protocol adherence and resolving site-related issues.

  • Build and maintain relationships with investigators and site staff.

  • Support sites with study system access and compliance with training requirements.

  • Assess site staff assignments and implement corrective actions if needed.

  • Identify and resolve documentation issues and compliance deficiencies.

  • Address site-related questions and ensure resolution of pending issues from previous visits.

  • Conduct literature reviews and data analysis to maintain study integrity.

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

  • Review, approve, and maintain site documentation, including regulatory compliance.

  • Evaluate and improve site recruitment plans in collaboration with site staff.

  • Conduct site visits, including qualification and initiation visits, and generate visit reports.

  • Assess and manage study supplies, including test article accountability and returns.

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

  • Conduct study-specific training and site facility assessments.

  • Monitor compliance and performance of sites and recommend corrective actions.

General Responsibilities:

  • Ensure timely and accurate completion of project goals.

  • Update trial management systems and monitor site-level data compliance.

  • Ensure all study sites are audit- and inspection-ready.

  • Maintain compliance with ICH-GCP and applicable international and local regulations.

  • Delegate and review administrative tasks as needed.

  • Maintain a positive and results-oriented work environment.

  • Provide input for performance development and proactively communicate work progress.

  • Develop expertise to become a subject matter expert in clinical research.

Required Skills:

  • Strong problem-solving skills and ability to work independently.

  • Advanced presentation and communication skills.

  • Client-focused approach and ability to interact professionally with stakeholders.

  • Ability to manage multiple tasks while maintaining accuracy and attention to detail.

  • Strong time management and analytical skills.

  • Proficiency in Clinical Trial Management Systems (CTMS), Electronic Document Management Systems (EDMS), and Microsoft Office.

  • Willingness to work in a team environment with a flexible attitude toward assignments.

  • Ability to accommodate extensive travel requirements and possess a valid driver's license if required.

Qualifications & Experience:

  • Degree in biological sciences, pharmacy, or a health-related discipline preferred, or an equivalent nursing qualification.

  • Previous site management or equivalent experience in clinical research.

  • Understanding of clinical trial methodologies and regulatory requirements.

Application Link: [Insert application link here]