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    Site Care Partner I

    Parexel
    2+ years
    preferred by company
    India Remote
    10 Jan. 21, 2025
    Job Description
    Job Type: Remote Education: B.SC,M.SC,B.PHARMA,M.PHARMA,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

    Site Care Partner I - India (Remote)

    Overview:

    As a Clinical Research Associate (CRA) at Parexel, you play a key role in accelerating the delivery of treatments to patients. Our CRAs are responsible for ensuring the safety and well-being of patients through monitoring activities. By traveling to investigator sites and performing various monitoring tasks, you’ll build relationships, take accountability, and maintain high integrity. This is an excellent opportunity to grow professionally within a diverse and collaborative team on global projects spanning a broad range of therapeutic areas.

    Key Responsibilities:

    1. Site Start-Up and Activation:

      • Implement GSSO site strategies for site qualification and activation.
      • Support site selection activities, including the review of potential sites and providing PTA output.
      • Collaborate with stakeholders for country-level input on surveys (e.g., protocol feasibility and medical practices).
      • Coordinate study start-up activities at the site level, including site activation checklist items and ICD finalization.
      • Ensure all site initiation activities are completed, including necessary training, document collection, and system updates.

    2. Study Conduct and Close-Out:

      • Act as the operational point of contact for site-level queries and escalate to appropriate teams for resolution.
      • Review site monitoring reports and provide support on revision and submission of ICD documents.
      • Manage site deliverables and ensure alignment across systems, including EDC, Shared Investigator Platform, and others.
      • Ensure continuous quality oversight during the study, ensuring data consistency and addressing site-level deliverables.
      • Assist in the management of decentralized capabilities, such as home health, ePRO, and DTP.

    3. Relationship Management:

      • Build and maintain positive relationships with investigator sites to support successful study outcomes.
      • Provide regular updates on site performance, addressing any recruitment or data entry issues.
      • Ensure site monitoring readiness for first subject visits and escalate any issues as necessary.
      • Work closely with Study Operations Managers to define local requirements for investigational product management and site support.

    4. Risk Management and Monitoring Efficiencies:

      • Proactively identify risks and implement mitigation strategies during study oversight.
      • Support the development of best practices for monitoring efficiency across sites and regions.
      • Contribute to shaping the clinical development environment, enhancing client reputation in scientific leadership.

    5. Proactive Site Intelligence:

      • Provide local intelligence and feedback on site performance, processes, and regulations to optimize site engagement.
      • Help develop recommendations based on a deep understanding of the country’s site practices and metrics.

    Qualifications:

    • Education: Bachelor’s degree or RN in a related field (or equivalent combination of education and experience) with a minimum of 5 years' experience.
    • Prior Experience:
      • Proven experience in site management and site monitoring.
      • Experience with start-up activities through to site activation and study conduct.
      • Knowledge of quality and regulatory requirements in relevant countries.
    • Technical Competencies:
      • Familiarity with Good Clinical Practice (GCP), ICH Guidelines, and applicable regulatory requirements.
      • Strong computer skills, with the ability to adopt new technologies.
      • Proficiency in English; knowledge of local language is preferred.
      • Ability to manage cross-functional relationships and communicate effectively with internal and external stakeholders.
    • Behavioral Competencies:
      • Strong problem-solving and relationship-building skills.
      • Effective verbal and written communication.
      • Ability to overcome barriers during process and system implementations.

    Travel Requirements:

    • Ability to travel up to 75% regularly.

    Why Parexel?

    Join a diverse and dynamic team at Parexel, where you'll have the opportunity to develop both personally and professionally. As a CRA, you'll collaborate with colleagues across the globe to contribute to life-changing projects and ensure the safety of patients throughout the clinical trial process.

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