POSITION SUMMARY:

The Project Support Specialist II serves as a member of the project team providing cross-functional support with the goal of contributing toward efficient management of the studies to which they are assigned. The Project Support Specialist II provides support on projects with some oversight. The Project Support Specialist II (PSS II) is a solid team member who can execute all core responsibilities consistently across several studies using independent judgment and critical thinking. The PSS II effectively collaborates with their cross-functional team members and will take on new or expanded responsibilities when appropriate and with proper training. The PSS II prioritizes their work and collaborates with the project team to ensure a consistent understanding of the timing for completion of work products.

• Schedules internal and external meetings, assists with preparing and circulating agendas, takes meeting minutes, circulates meeting minutes, and files meeting agendas and minutes in the Trial Master File.
• Creates and maintains the project timeline in MS Project or similar system. Ensures updates are captured and documented. Ensures the distribution of updates to study team members.
• Performs an array of activities in the Clinical Trial Management System (CTMS) including maintaining study milestone dates, updating study contact lists, maintaining enrollment projections as needed, and submitting helpdesk tickets and ensuring remediation is completed.
• Prepares, assigns, and documents study-specific training in appropriate systems; manages and oversees the maintenance of training records. Identifies gaps in training and engages appropriate team members or escalates as needed.
• Establishes a study-level Share Point site or similar shared working space and ensures appropriate access to study team, sponsors and others as appropriate.
• Creates project-specific email boxes and maintains appropriate access to study team members.
• Manages user access to study systems by submitting user requests to the HelpDesk or similar, by reviewing team member access on a define periodic basis, and document access review.
• Orders study supplies and addresses queries on study supplies.
• Orders initial study binders. Collects, collates and prepares study binders and ensures shipping to the proper locations through printing vendor.
• Maintains various study trackers as needed and directed by the Project Manager, Clinical Trial Manager or other project leader.
• Sends communications to study sites, investigators and others, as directed by the Project Manager, Clinical Trial Manager or other Project Leadership, including SUSARs, email blasts, newsletters and other information that may be required.
• May support the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the procedures defined by the study team in the project plan, as applicable, may be under Safety staff guidance.
• May support the translation process of site level documents, as applicable, per local and regional standards.
• May act as point of contact for project-related requests for team members, Sponsors, and third- party vendors.
• Supports the preparation, distribution, and the reconciliation of study material during applicable phases of the study (Operations Manual, ISF, patient cards, etc.) as applicable.
• May support team leaders with the production of various study reports and updates (e.g., country/site initiation, activation, recruitment).
• Performs other duties as assigned by the Project Manager, Clinical Trial Manager or other Project Leadership.