Project Support Specialist

This is a fully remote position, open to applicants in Poland, +4 more states.

📋 Description

• Develop and maintain project timelines using MS Project or comparable systems, ensuring updates are documented and shared with study team members.

• Organize internal and external meetings, creating and distributing agendas, taking minutes, and archiving records in the Trial Master File.

• Oversee study milestone dates, contact lists, enrollment forecasts, and helpdesk tickets within the Clinical Trial Management System.

• Prepare, assign, and document training specific to the study, monitor training records, and address any training deficiencies.

• Create and manage study-level SharePoint sites or equivalent shared workspaces, including access management.

• Establish project-specific email accounts and ensure proper access maintenance.

• Administer user access to study systems and carry out periodic access reviews.

• Procure study supplies and initial study binders; organize, compile, and manage shipping logistics.

• Maintain study trackers as directed by project leadership.

• Communicate with study sites, investigators, sponsors, and other stakeholders, including sending SUSARs, email updates, and newsletters.

• Assist in the distribution and tracking of IND Safety Reports/SUSARs/CIOMS.

• Facilitate translation of site-specific documents in accordance with local and regional standards.

• Serve as a point of contact for project-related inquiries from team members, sponsors, and third-party vendors.

• Aid in the preparation, distribution, and reconciliation of study materials.

• Support the production of study reports and updates, including country/site initiation, activation, and recruitment reports.

• Carry out additional tasks as assigned by project leadership.

⛳️ Requirements

• Bachelor’s degree or equivalent experience, preferably in a business, scientific, or healthcare field.

• At least 2 years of relevant experience in roles such as Clinical Trial Assistant, Clinical Support Specialist, or a similar position.

• Proficiency in Microsoft Office applications, including Outlook, Word, Excel, and PowerPoint.

• Ability to communicate effectively, both verbally and in writing, in proficient English at a professional standard.

• Familiarity with ICH-GCP, Precision SOPs, and relevant regulatory guidelines.

• Customer-oriented attitude, adaptability, teamwork, and a strong attention to detail.

• Excellent interpersonal abilities.

• High self-motivation and the capacity to work independently and collaboratively in a team setting.

• Strong written and verbal communication capabilities.

• Dedication to conducting oneself in a manner consistent with Precision Principles.

🏝️ Benefits

• Comprehensive health insurance coverage.

• Opportunities for professional development and growth.

• Flexible work arrangements to promote work-life balance.

• Collaborative and supportive work environment.