Project Support Specialist II

Summary

Join Precision Medicine Group as a Project Support Specialist II and contribute to the efficient management of clinical studies. You will provide cross-functional support, collaborating with team members to ensure timely completion of work products. Responsibilities include scheduling meetings, maintaining project timelines, managing study data in the CTMS, preparing training materials, and managing study-related communications. You will also maintain study trackers, order supplies, and support the preparation and distribution of study materials. The role requires a 4-year college degree or equivalent experience, at least 3 years of relevant experience, and proficiency in Microsoft Office Suite. Strong communication and interpersonal skills are essential. This is a remote position.

Requirements

• 4-year college degree, or equivalent experience ideally in a business, scientific or healthcare discipline
• Minimum of 3 years of relevant experience
• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, and PowerPoint)
• Customer service demeanor; 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

Responsibilities

• 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

Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave
• Paid time off for sick leave and vacation