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Sr. Clinical Trial Associate

3 months ago

New Brunswick, United States Allen Spolden Full time
Job Description
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