Clinical Trial Analyst Jobs

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Job Summary

The remote-based Senior Clinical Trial Associate (CTA) will independently perform tasks related to supporting operational strategy, planning, and execution of clinical studies, supporting the strategy as defined in the Clinical Development Plan.

• Collaborate with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities as defined by the clinical trial operating model.
• Perform departmental tasks as needed.
• Provide support for critical day-to-day clinical study activities, including regulatory inspection readiness, in accordance with established protocols under the general supervision of the CTA Manager.

Job Responsibilities

For assigned complex, accelerated, and/or business critical studies, provide support to focus on study start-up and site initiation activities, including but not limited to:

• Supporting additional ad-hoc activities as needed, as agreed with CTA Manager.
• Supporting oversight of risk-based monitoring.
• Review and/or approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
• Attendance of key team meetings as required; may make presentations (e.g. data, etc.).
• Supporting regulatory inspection readiness (e.g. preparation of materials and/or participation during regulatory inspections.)

For all assigned studies, provide support including:

• Maintaining knowledge of systems and processes.
• Escalation of clinical trial insurance issues.
• Attending internal and external trainings as needed and maintaining up-to-date training record.
• Provide support for departmental tasks, including but not limited to:
• Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors.
• Supporting Health Care Provider Engagement for facilitating contracts and meetings.
• Supporting vendor contract administration as required.