Project Support Specialist

The Project Support Specialist will serve as a member of the project team, providing cross-functional support to efficiently manage assigned clinical studies at Precision for Medicine, a Clinical Research Organization specializing in precision medicine, rare diseases, and oncology.

Key Responsibilities:

• Creates and maintains the project timeline in MS Project or similar systems, ensuring updates are captured, documented, and distributed to study team members.
• Schedules internal and external meetings, prepares and circulates agendas, takes meeting minutes, and files meeting agendas and minutes in the Trial Master File.
• Performs an array of activities in the Clinical Trial Management System (CTMS), including maintaining study milestone dates, updating study contact lists, managing enrolment projections, and submitting helpdesk tickets for remediation.
• Prepares, assigns, and documents study-specific training in appropriate systems, manages training records, and identifies gaps in training.
• Establishes a study-level SharePoint site or similar shared working space, ensuring appropriate access for study teams, sponsors, and others.
• Creates project-specific email boxes and maintains access for study team members.
• Manages user access to study systems by submitting user requests to the Help Desk, reviewing team member access periodically, and documenting access reviews.
• Orders study supplies and addresses queries related to study supplies.
• Orders initial study binders, collects, collates, and prepares study binders, and ensures shipping to the proper locations through printing vendors.
• Maintains various study trackers as directed by the Project Manager, Clinical Trial Manager, or other project leaders.
• Sends communications to study sites, investigators, and others as directed by project leadership, including SUSARs, email blasts, newsletters, and other required information.
• May support the distribution and tracking of IND Safety Reports/SUSARs/CIOMS under Safety staff guidance.
• May support the translation process of site-level documents as applicable, per local and regional standards.
• Acts as a point of contact for project-related requests from team members, sponsors, and third-party vendors.
• Supports the preparation, distribution, and reconciliation of study materials during applicable phases of the study (Operations Manual, ISF, patient cards, etc.).
• 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.

Qualifications:

Minimum Required:

• A 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.

Other Required:

• Fluency in the Microsoft Office package of programs (Outlook, Word, Excel, PowerPoint).
• Customer service demeanor; demonstrate flexibility, teamwork, and a keen attention to detail.
• Ability to communicate both verbally and in writing at the professional level in English.
• 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 independently as well as in a team environment.
• Strong written and verbal communication skills.
• Commitment to performing professionally consistent with Precision Principles.