Sr. Clinical Trial Associate

The remote -based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy and and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.
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• Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager.
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• Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
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• Perform departmental tasks.
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• Perform developmental tasks with oversight of CTA Manager.
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  ACCOUNTABILITIES:<\/b>
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  For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
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  • Approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
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  • Support oversight of risk -based monitoring.
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  • Attend important team meetings.
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  • Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
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  • Support additional ad -hoc activities, as agreed with CTA Manager.
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  • Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.
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  • Escalate clinical trial insurance issues.
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  • Support Health Care Provider Engagement for facilitating contracts and meetings.
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  • Support vendor contract administration.
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    Requirements<\/h3>

    • Bachelor's degree or equivalent international degree.
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    • 5 or more years' experience in pharmaceutical industry, clinical research organization, or related role.
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    • Experience in Phase 2 and 3 studies and global/international studies is advantageous.
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    • Experience working across multiple therapeutic areas is advantageous.
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    • Knowledge in global regulatory and compliance requirements for clinical research.
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    • Excellence in task management and collaboration.
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    • Requires availability for 5 -10% domestic and international travel, including overnight and international travel on an as -needed basis.
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      Benefits<\/h3>

      • 401(k) with company match and Annual Retirement Contribution Plan
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      • Tuition reimbursement Company match of charitable contributions
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      • Health & Wellness programs including onsite flu shots and health screenings
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      • Generous time off for vacation and the option to purchase additional vacation days
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      • Community Outreach Programs
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