Clinical Trial Associate II

12 hours ago


Raleigh, North Carolina, United States Allen Spolden Full time
Job Title: Clinical Trial Associate II

Job Summary:

We are seeking a highly motivated and detail-oriented Clinical Trial Associate II to join our team at Allen Spolden. As a Clinical Trial Associate II, you will play a critical role in supporting the operational strategy and execution of clinical studies.

Key Responsibilities:

* Provide support for essential daily clinical study activities, including regulatory inspection readiness and following established protocols.
* Work with Clinical Operations Manager, study teams, and Clinical Research Organizations (CROs) to support clinical study activities.
* Perform departmental tasks and 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 vendor contract administration.

Requirements:

* Associate or Bachelor's degree in Life Sciences or Healthcare.
* 2 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 contribution.
* Generous time off for vacation and the option to purchase additional vacation days.

About Us:

Allen Spolden is a leading pharmaceutical company dedicated to improving human health through innovative research and development. We offer a dynamic and supportive work environment, competitive compensation and benefits, and opportunities for professional growth and development.

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