Project Specialist

• Partner with the Project Manager to ensure overall project delivery through coordination and oversight of the cross-functional project team
• Facilitate team communications and maintain internal and external project documentation
• Maintain internal and external project team contact lists
• Schedule internal and external team meetings, develop agendas, capture minutes, and manage action/decision logs
• Create and distribute study newsletters as required
• Manage and track budgets related to vendor projects, including supplies and invoices
• Track out-of-scope services and assist in preparing Change Orders
• Track supplies, invoices, and budgets relating to vendor management
• Ensure projects are audit ready
• Create and manage required project systems, SOP indices, and study team lists
• Manage study team/contact lists, system access requests, and email distribution lists

• Associate’s degree (or equivalent) level of qualification in life sciences, Medicine, Pharmacy, Nursing or related field and a minimum of 2 years of clinical research experience
• OR a Bachelor’s degree, or international equivalent, preferably in a clinical, biological, scientific, business, or health-related field, and a minimum of 1 year of professional work experience in clinical research, healthcare, business, finance, and/or project management preferred
• Basic knowledge of ICH/GCP regulations
• Working knowledge of FDA guidance documents/EU directives/ISO14155 regulations, drug/device development, and clinical monitoring procedures
• Basic knowledge of project management terminology and guidelines
• Strong computer skills in MS office suite required
• Immediately available or only a short notice period to be considered
• This role is offered as a 1 year Fixed Term Contract on Premier Research payroll

• Health insurance
• Life insurance
• Retirement plan
• Paid time off
• Employee Assistance Program
• Flexibility and balance to support your life requirements