- 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.
- 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.
- Bachelor's degree or equivalent international degree.
- 3 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.
- 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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Clinical Trial Associate II - New Brunswick, United States - Allen Spolden
Description
Job DescriptionThe 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.
For assigned complex, accelerated, and business essential studies, provide support to focus on study startup and site initiation activities, including:
