Senior Clinical Trial Associate (remote)

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Job Description

OBJECTIVES/PURPOSE:

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.

• Provide support for critical day-to-day clinical study activities, including inspection readiness and/or oversight of inspection deliverables and/or milestones, in accordance with established protocols under the general supervision of the CTA Manager.
• 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, including acting as a subject matter expert or oversee initiatives and/or processes; act as mentor to junior CTA team members.
• Perform developmental tasks as appropriate with oversight of CTA Manager.

ACCOUNTABILITIES:

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:

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

For all assigned studies, provide support including:

• Collaboration with internal departments (Legal, Insurance, R&D functions, etc.), CROs, and external vendors.
• Escalation of clinical trial insurance issues.
• Supporting Health Care Provider Engagement for facilitating contracts and meetings.
• Supporting vendor contract administration as required.

Provide support for departmental tasks, including but not limited to:

• Maintaining knowledge and acts as team super-user or subject matter expert for related systems and processes; provide presentations, training, and support to CTA team as needed; provide updates to applicable CTA resources as needed.
• Participating in and/or leading functional initiatives and/or working groups.
• Assisting with special projects and/or tasks as required.
• Acting as mentor to junior CTA team members.
• Supporting new CTA team member onboarding.

Perform developmental tasks as appropriate with oversight of CTA Manager, including:

• Career development and goal setting.
• Targeted skill development and/or growth of knowledge base.

CORE ELEMENTS RELATED TO THIS ROLE: 

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. The Senior CTA will provide support for critical day-to-day clinical study activities, including regulatory inspection readiness and/or oversight of regulatory inspection deliverables and/or milestones, in accordance with established protocols under the general supervision of the CTA Manager. The Senior CTA w