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Clinical Research Associate

0-2 years
Not Disclosed
10 April 16, 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)


Job Location:

Bengaluru, India


Company:

Parexel


Job Type:

Full-time, On-site with Travel


Role Overview:

As a Clinical Research Associate (CRA) at Parexel, you will play a key role in advancing clinical trials and ensuring the safety and integrity of patient data. Acting as the primary contact between the site and sponsor, your role will involve site monitoring, issue resolution, protocol compliance, and relationship building with site staff—all to help bring treatments to patients sooner.


Key Responsibilities:

Monitoring & Site Support:

  • Act as Parexel’s representative at assigned sites throughout all trial phases.

  • Conduct site visits (qualification, initiation, monitoring, close-out).

  • Ensure protocol, GCP, and regulatory compliance.

  • Provide site staff with access to study systems and ensure training compliance.

  • Resolve site issues including documentation gaps and non-compliance.

  • Review regulatory documents and ensure audit-readiness of sites.

  • Monitor site recruitment and develop improvement strategies.

Trial Operations & Documentation:

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

  • Ensure completeness and quality of Trial Master File (TMF).

  • Oversee investigational product supply and accountability.

  • Follow up on SAE reporting, CRF data entry, and site payments.

  • Generate timely and detailed visit reports.

Cross-functional Collaboration:

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

  • Collaborate with project team to meet goals and milestones.

  • Support Administrative Support Teams with delegated tasks.

  • Maintain compliance with ICH-GCP, SOPs, and local regulations.


Skills & Competencies:

  • Strong problem-solving and analytical thinking.

  • Excellent interpersonal, communication, and client-facing skills.

  • Ability to work independently with minimal supervision.

  • Organizational and time management skills with multitasking ability.

  • Proficient in MS Office and clinical trial software (CTMS, EDMS).

  • Team player with a flexible and proactive mindset.

  • Attention to detail and commitment to high-quality work.

  • Willingness to travel extensively; valid driver’s license required.


Experience Requirements:

  • Previous experience in site management or equivalent clinical research roles.

  • Knowledge of clinical trial methodology and terminology.


Education Requirements:

  • Bachelor’s degree in Life Sciences, Pharmacy, Nursing, or related field.

  • Equivalent nursing qualification or relevant clinical research experience also accepted.


Why Join Parexel?

  • Global exposure to a wide range of therapeutic areas.

  • Inclusive and collaborative team environment.

  • Opportunities for personal and professional development.

  • Contribute to innovative treatments that make a difference