Clinical Trial Associate II

Job Opportunity

The remote-based Clinical Trial Associate (CTA) will perform tasks related to supporting operational strategy 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 include providing support to focus on study startup and site initiation activities, including approval of study documentation, support oversight of risk-based monitoring, attending important team meetings, supporting regulatory inspection readiness, supporting additional ad-hoc activities, working with internal departments, CROs, and vendors, escalating clinical trial insurance issues, supporting Health Care Provider Engagement for facilitating contracts and meetings, and supporting vendor contract administration.

Requirements include a 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, and availability for 5-10% domestic and international travel, including overnight and international travel on an as-needed basis.

Benefits include 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, and community outreach programs.