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    Central Cra (Clinical Research Associate)- Registries

    Sanofi
    3+ years
    Not Disclosed
    Hyderabad
    10 Dec. 24, 2024
    Job Description
    Job Type: Full Time Education: B.Sc./M.Sc./B.Pharm/M.Pharm/Life science Skills:

    Job Title: Clinical Research Associate (CRA)
    Location: [Specify Location]

    About the Job

    At Sanofi, we are dedicated to bringing miracles of science to life. As a Clinical Research Associate (CRA), you will play a vital role in supporting the execution of clinical trials for investigational studies. You will be involved in a wide array of activities, from study start-up and site monitoring to managing clinical trial data, ensuring regulatory compliance, and contributing to the successful progression of trials.

    Main Responsibilities:

    Study Start-up Activities:

    • Site Documentation: Assist in collecting and reviewing site documents for regulatory submission (HA/RA/EC/IRB).
    • Insurance and Contracts: Prepare Insurance Certificate applications and assist in contract negotiations and final agreements with sites.
    • Study Customization: Ensure customization of the Informed Consent Form (ICF) based on country requirements, incorporating site-specific details, and maintaining version control.
    • Study Documentation Upload: Assist with the uploading and filing of Study Start-up documentation into the eTMF.
    • Stakeholder Communication: Maintain effective communication with internal and external stakeholders regarding project progress, issues, and any changes.

    Site Monitoring (Off-Site & On-Site):

    • Remote Monitoring: Conduct off-site monitoring activities in line with protocol, ICH-GCP, and applicable regulations for site selection, initiation, routine monitoring, and close-out visits.
    • On-Site Monitoring: Plan, prepare, and perform on-site visits, ensuring compliance with protocol, GCP, and local regulations.
    • Data Review and Quality Control: Monitor the quality of study data and ensure completeness of the electronic Case Report Form (eCRF), addressing any discrepancies and queries in coordination with Data Management teams.

    Site Management:

    • Patient Recruitment & Site Facilities: Support patient recruitment efforts and ensure site facilities meet protocol and regulatory standards.
    • Staff Training & Relationship Management: Ensure site staff are properly trained and that collaborative relationships are developed and maintained.

    Safety & Quality Control:

    • Safety Reporting: Ensure that safety information is properly reported to the EC/IRB/RA according to local regulations.
    • Quality Assurance: Maintain an "audit/inspection readiness" mindset, identifying issues or deviations and implementing corrective and preventive actions (CAPA) as needed.

    Study Administration:

    • Data Management: Maintain trackers and databases to monitor study progress at the local and global levels.
    • TMF Compliance: Contribute to the eTMF process throughout the study lifecycle, ensuring timely and accurate document collection and management.
    • Study Meetings & Training: Participate in local and international meetings, audits, and training sessions as necessary.

    Performance & Process:

    • Study Timelines & Quality: Ensure adherence to monitoring plans, study timelines, and regulatory compliance.
    • Patient Recruitment & Retention: Support recruitment and retention strategies to enhance trial progress.
    • Regulatory Compliance: Ensure adherence to GCP and regulatory requirements throughout study execution.
    • Reporting Efficiency: Maintain accuracy and timeliness of monitoring visit reports and study documentation.

    Stakeholder Management:

    • Communication & Collaboration: Effectively communicate with site staff, sponsors, regulatory bodies, and other stakeholders to ensure alignment and resolve issues promptly.
    • Compliance & Ethics: Ensure all stakeholders adhere to ethical and regulatory guidelines.
    • Conflict Resolution & Feedback: Resolve conflicts and gather feedback to improve processes and relationships.

    About You

    Experience:

    • 3+ years of experience in clinical research, including clinical trial monitoring.
    • Experience with rare diseases, observational studies, or real-world evidence is a plus.
    • Familiarity with clinical trial processes, GCP, and regulatory guidelines.

    Soft Skills:

    • Communication: Excellent written and oral communication skills.
    • Adaptability: Ability to adjust to changing trial requirements and environments.
    • Problem-Solving: Strong ability to address issues that arise during trials.
    • Time Management: Efficiently manage tasks and prioritize responsibilities.
    • Interpersonal Skills: Build and maintain positive relationships with stakeholders.

    Technical Skills:

    • Clinical Trial Knowledge: Understanding of GCP, clinical trial phases, and protocols.
    • Regulatory Knowledge: Familiarity with FDA, EMA, and other relevant guidelines.
    • Data Management: Ability to collect, analyze, and report trial data.
    • Medical Terminology: Proficiency in medical terminology and clinical procedures.
    • Technical Tools: Competence in Microsoft Office and relevant clinical research tools.

    Education:

    • Degree in a pharmaceutical/scientific discipline or a related life science field.

    Languages:

    • High proficiency in written and spoken English.

    Why Choose Us?

    At Sanofi, you will have the opportunity to work with a diverse and inclusive team that shares a passion for science and innovation. We offer ample opportunities for career growth, with competitive benefits and support for your professional development. Together, we will chase progress and make a meaningful difference in healthcare.

    Apply now to be part of a global team driving extraordinary impact in the field of clinical research.

    Sanofi is committed to providing equal opportunities to all individuals regardless of race, color, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, or gender identity.

    Watch our ALL IN video and check out our Diversity, Equity, and Inclusion initiatives at Sanofi.com.

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