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4 Dec. 10, 2024
Job Description
Job Type: Full Time Education: B.Pharm / M.Pharm / M.Sc 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)

Experience Required: 4–6 Years
Educational Qualification: B.Pharm / M.Pharm / M.Sc
Location: Ahmedabad


Job Description

We are looking for a dedicated Clinical Research Associate (CRA) to join our dynamic clinical research team in Ahmedabad. The ideal candidate will have hands-on experience in conducting clinical trials, ensuring compliance with regulatory guidelines, and supporting the research process from initiation to completion.


Key Responsibilities

  • Study Management: Oversee and manage clinical trials, ensuring that they are conducted according to the study protocol, applicable regulations, and Good Clinical Practice (GCP) guidelines.

  • Site Monitoring: Perform site selection, initiation, monitoring, and close-out visits. Ensure sites meet all compliance, regulatory, and operational standards.

  • Data Collection and Analysis: Ensure proper collection and documentation of trial data. Review data for completeness, accuracy, and compliance with the study protocol.

  • Collaboration: Coordinate with cross-functional teams, including project managers, investigators, and regulatory teams, to ensure smooth trial execution.

  • Regulatory Compliance: Maintain up-to-date knowledge of regulatory requirements, including GCP, ICH, and local regulations. Ensure adherence to all ethical and regulatory guidelines.

  • Reporting and Documentation: Generate and review clinical trial documents such as monitoring visit reports, and ensure timely submission of clinical data and documents to regulatory bodies.

  • Training and Support: Provide guidance and training to clinical trial staff, including site personnel, on study protocols and regulatory requirements.


Candidate Requirements

  • Educational Background:

    • Bachelor’s or Master’s degree in Pharmacy (B.Pharm / M.Pharm) or Life Sciences (M.Sc).

  • Experience:

    • 4–6 years of experience in clinical research, specifically in clinical monitoring, clinical trials, or clinical operations.

  • Knowledge and Skills:

    • Strong knowledge of GCP, ICH guidelines, and regulatory requirements.

    • Excellent understanding of clinical trial processes, from site initiation to close-out.

    • Ability to interpret clinical data and regulatory documents.

    • Strong organizational, problem-solving, and time management skills.

    • Excellent written and verbal communication skills.

  • Certifications (Preferred):

    • CRA certification (e.g., ACRP or SOCRA) is preferred but not mandatory.


Why Join Us?

  • Work with a leading team in the clinical research field and gain exposure to diverse projects.

  • Competitive compensation and career growth opportunities.

  • A collaborative and inclusive work environment.

  • Access to ongoing professional development and training.

Take the next step in your clinical research career by applying for the CRA position in Ahmedabad. Help us bring life-changing therapies to market and improve global health outcomes!