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    Veeda Clinical Research Limited
    4-7 years
    Not Disclosed
    Ahmedabad
    10 June 25, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, 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 Description: Clinical Research Associate (CRA)

    Company: Veeda Clinical Research Limited
    Location: Ahmedabad, India
    Position: Clinical Research Associate (CRA)
    Experience: 4-6 Years
    Qualification: B.Pharm / M.Pharm / M.Sc

    Company Overview

    Veeda Clinical Research Limited is a leading Contract Research Organization (CRO) dedicated to providing comprehensive clinical trial services. With a commitment to scientific excellence and regulatory compliance, we partner with pharmaceutical and biotechnology companies to advance healthcare through innovative research.

    Job Summary

    As a Clinical Research Associate (CRA) at Veeda Clinical Research Limited, you will play a pivotal role in the execution and management of clinical trials. You will ensure compliance with study protocols, regulatory requirements, and company procedures while contributing to the successful conduct of clinical research projects.

    Key Responsibilities

    • Study Execution and Monitoring:

      • Conduct site initiation, routine monitoring, and close-out visits according to study protocols, SOPs, ICH-GCP guidelines, and applicable regulatory requirements.
      • Ensure clinical trials are conducted in adherence to protocol requirements and monitor the conduct of clinical trials at investigator sites.

    • Site Management and Coordination:

      • Evaluate the adequacy of investigator sites and ensure readiness for study initiation.
      • Provide guidance and support to investigators and site staff to resolve study-related issues promptly.

    • Documentation and Reporting:

      • Maintain accurate and timely documentation of all site visit activities.
      • Prepare and submit visit reports, follow-up letters, and other study-related documentation as per SOPs.

    • Quality Assurance and Compliance:

      • Perform quality checks and verification of clinical data and trial documentation.
      • Ensure completeness, accuracy, and integrity of clinical trial data reported by sites.

    • Communication and Collaboration:

      • Liaise effectively with study stakeholders, including investigators, site staff, project managers, and sponsors.
      • Participate in study team meetings, conference calls, and training sessions as required.

    • Risk Management and Issue Resolution:

      • Identify risks to study timelines or data quality and develop mitigation strategies.
      • Escalate study issues and deviations to the project team and propose corrective actions.

    • Continuous Improvement:

      • Contribute to process improvement initiatives to enhance efficiency and quality in clinical trial conduct.
      • Share best practices and lessons learned with the broader team to promote continuous learning and development.

    Qualifications and Skills

    • 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 as a Clinical Research Associate in the pharmaceutical or CRO industry.
      • Proven track record of monitoring clinical trials and managing investigative sites.

    • Technical Skills:

      • Thorough understanding of clinical trial processes, ICH-GCP guidelines, and regulatory requirements.
      • Proficiency in clinical trial monitoring, site management, and data quality assurance.

    • Soft Skills:

      • Excellent communication and interpersonal skills, with the ability to build effective relationships with stakeholders.
      • Strong organizational and time management skills, with attention to detail and accuracy.

    • Problem-Solving Abilities:

      • Analytical mindset with the ability to identify issues and propose solutions.
      • Ability to work independently and collaboratively within a team environment.

    What We Offer

    • Competitive salary and benefits package.
    • Opportunities for career growth and professional development in clinical research.
    • A supportive and collaborative work environment committed to scientific excellence and innovation.

    How to Apply

    Interested candidates who meet the qualifications are encouraged to submit their resume and cover letter to careers@veedacr.com with the subject line "Application for Clinical Research Associate - Ahmedabad."

    Join Veeda Clinical Research Limited and contribute to advancing healthcare through high-quality clinical research and innovative trial solutions.

    Note: This job description provides a general overview and may include additional responsibilities and qualifications as required by Veeda Clinical Research Limited.

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