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Clinical Research Associate Ii

2+ years
Not Disclosed
10 April 30, 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 II
Location: Bengaluru, India
Employment Type: Full-time

About Parexel:

Parexel is a leading global provider of solutions to the pharmaceutical, biotechnology, and medical device industries. As a Clinical Research Associate (CRA) at Parexel, you will contribute directly to advancing treatments for patients. You will work with clinical sites to ensure that safety and well-being are prioritized, while also maintaining the integrity and quality of data through monitoring and managing clinical trials.

Key Responsibilities:

  • Act as the primary contact for assigned clinical sites and ensure site quality and adherence to study protocols from initiation through to close-out.

  • Build and maintain strong relationships with investigators and site staff.

  • Perform site evaluations, assess compliance with regulations, and develop patient recruitment strategies.

  • Oversee trial conduct, ensuring the rights and safety of human subjects are protected, and evaluate the quality of data and staff training.

  • Solve site-specific issues and resolve deficiencies through problem-solving and effective communication.

  • Conduct site visits (Qualification, Initiation, Monitoring, Close-out) and provide training where necessary.

  • Ensure compliance with Good Clinical Practice (GCP), regulatory requirements, and Parexel SOPs.

  • Manage and track test article/study supplies, ensuring their proper accountability and return status.

  • Regularly update clinical trial management systems (CTMS) with site data, ensuring high-quality data entry compliance and document management.

  • Participate in audits and regulatory inspections and ensure site readiness for them.

Required Skills and Qualifications:

  • Education: Degree in Biological Science, Pharmacy, or other health-related disciplines; equivalent nursing qualification or related experience.

  • Experience: Previous site management or clinical research experience with understanding of clinical trial methodologies.

  • Skills:

    • Strong problem-solving, organizational, and interpersonal skills.

    • Proficiency in CTMS, Electronic Document Management Systems (EDMS), and MS Office (Excel, Word).

    • Ability to prioritize tasks and manage multiple responsibilities.

    • Effective communication skills, both verbal and written.

    • Willingness to travel extensively depending on project needs.

    • Commitment to delivering high-quality work in a fast-paced environment.

    • Ability to work independently and as part of a team, with a client-focused approach.

Key Accountabilities:

  • Ensure the timely and accurate completion of all project goals and updates.

  • Maintain site compliance and readiness for audits and inspections.

  • Manage site issues and provide solutions proactively.

  • Work collaboratively with team members to meet project milestones.

  • Ensure patient safety and data integrity throughout the trial.