Creates and maintains the project timeline in MS Project or similar system
Schedules internal and external meetings, assists with preparing agendas, takes meeting minutes, circulates them, and files in the Trial Master File
Performs activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, and submitting helpdesk tickets
Prepares, assigns, and documents study-specific training in appropriate systems; manages training records
Establishes a study-level Share Point site or similar shared working space
Creates project-specific email boxes and maintains appropriate access
Manages user access to study systems by reviewing team member access on a periodic basis
Orders study supplies and addresses queries on study supplies
Collects, collates and prepares study binders and ensures shipping through printing vendor
Maintains various study trackers as needed and directed by project leaders
Sends communications to study sites, investigators and others
May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS
Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study
Performs other duties as assigned by project leaders

4-year college degree, or equivalent experience ideally in a business, scientific or healthcare discipline
Minimum of 2 years of relevant experience as a Clinical Trial Assistant, Clinical Support Specialist or similar position
Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
Customer service demeanour; demonstrate flexibility, teamwork, and a keen attention to detail
Ability to communicate both verbally and in writing at the English proficiently (Professional level)
Working knowledge of ICH-GCP, Precision SOPs, and regulatory guidance
Demonstrates solid interpersonal skills
Exhibits strong self-motivation, is detail-oriented and able to work and plan independently as well as in a team environment
Strong written and verbal communication skills
Commitment to performing professionally consistent with Precision Principles

Project Support Specialist

Key skills