Instagram
youtube
Facebook

Clinical Research Associate Ii (Icra Ii)

Fresher years
upto 5 LPA
10 Nov. 18, 2025
Job Description
Job Type: Full Time Education: B.Pharm, M.Pharm, Pharm D., BSc., MSc. 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

Clinical Research Associate II (iCRA II) – Parexel | Bengaluru, India

Job ID: R0000036655
Category: Clinical Trials
Date Posted: 17 November 2025
Experience Required: Fresher candidates eligible

About the Role

Parexel is hiring a Clinical Research Associate II (iCRA II) to support end-to-end clinical trial execution across diverse therapeutic areas. This role plays a critical part in ensuring patient safety, maintaining data integrity, and delivering high-quality clinical operations. As part of Parexel’s global clinical research team, you will collaborate with investigators, site staff, and cross-functional experts while gaining hands-on exposure to international clinical trial processes.

This position is ideal for freshers who want to build a long-term career in clinical research and contribute to global drug development.


Key Responsibilities

1. Start-Up Activities (Site Identification to Activation)

  • Serve as the primary point of contact for assigned investigator sites during the start-up phase.

  • Build and maintain strong professional relationships with investigators and clinical site personnel.

  • Support feasibility assessments, site qualification activities, and confidentiality agreement execution.

  • Conduct remote qualification visits as required.

  • Collaborate with internal teams to manage Clinical Site Agreement timelines.

  • Ensure First Time Quality (FTQ) for all country-specific and site-level TMF documentation.

  • Configure, distribute, collect, and approve essential regulatory documents for site activation.

  • Review, customize, and negotiate Informed Consent Forms (ICF) and translations within regulatory parameters.

  • Prepare and submit IRB/IEC and MoH/Regulatory Authority applications, ensuring timely follow-up and approval.

  • Upload critical documents into the Trial Master File (TMF) in alignment with project plans.

  • Forecast, manage, and revise strategies for regulatory submissions, approvals, and site activation milestones.

  • Troubleshoot and resolve operational issues, delays, or risks related to site readiness and recruitment.

  • Ensure all site personnel are trained and have access to study systems before study start.

2. Maintenance Phase (Initiation to Close-Out)

  • Continue reviewing and negotiating ICF versions and amendments during ongoing trial maintenance.

  • Manage IRB/IEC and MoH submissions, approvals, and documentation updates.

  • Submit all required documentation to the TMF with a high level of accuracy and completeness.

3. Oversight Across the Site Lifecycle

  • Track progress against project goals and ensure timely updates in CTMS and other clinical systems.

  • Maintain data quality and accuracy across site and country-level records.

  • Ensure each site is inspection-ready at all times.

  • Uphold ICH-GCP, local regulatory guidelines, SOPs, and sponsor-specific procedures.

  • Maintain a positive, collaborative, and high-performance work environment.

  • Demonstrate ownership, accountability, and proactive communication on project risks and timelines.

  • Support continuous learning, process adherence, and quality-driven deliverables.


Required Skills

  • Strong analytical and problem-solving ability.

  • Capacity to work independently with sound judgment in ambiguous situations.

  • Excellent communication, presentation, and interpersonal skills.

  • Ability to manage multiple tasks and meet study timelines.

  • Strong computer proficiency, especially in CTMS, eTMF, MS Word, and Excel.

  • High attention to detail and commitment to quality.

  • Ability to collaborate effectively in global and virtual team environments.

  • Professional attitude with a client-focused approach.


Knowledge and Experience

  • Substantial understanding of clinical research processes, clinical trial terminology, and site operations.

  • Prior exposure through internships, academic projects, or certifications is advantageous but not mandatory for freshers.


Education

  • Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, Nursing, or a related health discipline.