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