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    Site Care Partner I

    Parexel
    5+ years
    Not Disclosed
    India
    10 Jan. 21, 2025
    Job Description
    Job Type: Full Time Remote Education: B.Sc, M.Sc, B.Pharm, M.Pharm, LifeScience Graduates 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
    Location: India, Remote
    Company: Parexel

    About This Role

    As a Site Care Partner I at Parexel, you will play a crucial role in ensuring the operational success of clinical studies by managing site start-up, activation, and oversight. Your responsibilities will include building and maintaining strong relationships with investigator sites, ensuring quality and compliance throughout the study lifecycle, and supporting recruitment and enrollment efforts. This role also involves close collaboration with various stakeholders to manage site-level issues and ensure the effective delivery of the study.

    Responsibilities

    1. Site Start-Up and Activation:

    • Deploy GSSO site strategies to qualify and activate assigned sites.
    • Support country and site selection activities, including reviewing the draft site list and providing PTA output.
    • Collaborate with key stakeholders to provide input on protocol feasibility, country SOC, and medical practices.
    • Maintain a thorough knowledge of assigned protocols.
    • Conduct study start-up activities, including PTA, site activation checklist coordination, ICD finalization, and SIV.
    • Ensure completion of all site initiation activities (e.g., training, documentation, systems) necessary for site activation.
    • Partner with site monitors to ensure readiness for the first subject visit.

    2. Relationship Building and Operational Oversight:

    • Provide study support and coordinate efforts to resolve site issues (e.g., vendor, contract, payment issues).
    • Oversee IP and ancillary supply strategies for sites throughout the study lifecycle.
    • Ensure effective site recruitment planning and address issues affecting recruitment.
    • Maintain regular communications with investigator sites to gather status updates and drive progress toward study goals (e.g., recruitment, data entry timelines).

    3. Study Conduct and Close-Out:

    • Act as the operational point of contact for all site-level questions, escalating issues as necessary.
    • Review Site Monitoring Reports and support the revision and submission of ICD documents and amendments.
    • Ensure system management (e.g., EDC, Shared Investigator Platform) at the site level is consistent across platforms.
    • Monitor site deliverables, including data cuts, interim analyses, and database locks.
    • Follow the study oversight plan, proactively implementing risk mitigation strategies.
    • Support decentralized capabilities at investigator sites, such as home health, ePRO, and DTP.

    4. Site Performance and Efficiency:

    • Drive best practices and efficiencies to improve site performance and strengthen site relationships.
    • Support the development and delivery of decentralized solutions at sites, addressing any issues.
    • Foster positive relationships with investigators and escalate compliance or training concerns.
    • Provide input into site recommendations based on local knowledge and performance metrics.

    5. Communication and Collaboration:

    • Ensure clear and open communication with the Study Operations Manager.
    • Proactively provide local intelligence to enhance site performance and contribute to study success.
    • Collaborate with other roles to ensure alignment and effective study delivery.

    Qualifications

    Training and Education:

    • Bachelor’s degree or RN in a related field, or equivalent combination of education, training, and experience (at least 5 years of experience).
    • Proficiency in the local language is preferred; English is required.

    Prior Experience:

    • Demonstrated experience in site management, with prior experience as a site monitor.
    • Proven experience in site start-up, activation, conduct, and close-out activities.
    • Knowledge of quality and regulatory requirements in applicable countries.

    Technical Competencies:

    • In-depth knowledge of Good Clinical Practice (GCP), ICH Guidelines, and other regulatory requirements.
    • Strong computer skills and the ability to adapt to new technologies.
    • Excellent communication, presentation, and interpersonal skills.
    • Ability to manage up to 75% travel on a regular basis.
    • Strong networking and relationship-building skills.
    • Ability to manage cross-functional relationships and communicate effectively with stakeholders.

    Behavioral Competencies:

    • Ability to overcome barriers in the implementation of new processes and systems.
    • Strong relationship-building skills with investigator site staff and other stakeholders.
    • Effective verbal and written communication skills with colleagues and external partners.

    Why Parexel?

    At Parexel, we are united in our goal to improve global health. As a Site Care Partner, you will be integral in ensuring that new treatments reach patients faster while upholding the safety and well-being of those patients. If you're looking to grow personally and professionally in a dynamic global environment, this is the perfect opportunity for you.

    Join Parexel and make a difference in clinical research.

     

     

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