Sr. Clinical Trial Associate
2 weeks ago
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.
- Provide support for essential daily clinical study activities, including regulatory inspection readiness, following established protocols under the general management of the CTA Manager.
- 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.
- Perform departmental tasks.
- Perform developmental tasks with oversight of CTA Manager.
ACCOUNTABILITIES:
For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
- Approval of study documentation, including essential document packets, study plans, informed consent forms, etc.
- Support oversight of risk-based monitoring.
- Attend important team meetings.
- Support regulatory inspection readiness (e.g. preparation of materials and participation during regulatory inspections.)
- Support additional ad-hoc activities, as agreed with CTA Manager.
- Work with internal departments (Legal, Insurance, R&D functions), CROs, and vendors.
- Escalate clinical trial insurance issues.
- Support Health Care Provider Engagement for facilitating contracts and meetings.
- Support vendor contract administration.
Requirements
- Bachelor's degree or equivalent international degree.
- 5 or more years' experience in pharmaceutical industry, clinical research organization, or related role.
- Experience in Phase 2 and 3 studies and global/international studies is advantageous.
- Experience working across multiple therapeutic areas is advantageous.
- Knowledge in global regulatory and compliance requirements for clinical research.
- Excellence in task management and collaboration.
- Requires availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis.
Benefits
- 401(k) with company match and Annual Retirement Contribution Plan
- Tuition reimbursement Company match of charitable contributions
- Health & Wellness programs including onsite flu shots and health screenings
- Generous time off for vacation and the option to purchase additional vacation days
- Community Outreach Programs
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