Clinical Trial Associate II

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.
  

• 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.
  

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