Project Support Specialist

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

📋 Description

• Act as a key member of the project team, offering cross-functional support to ensure the effective management of assigned clinical studies.

• Develop and maintain project timelines using MS Project or similar tools; document and share updates.

• Organize internal and external meetings; prepare and distribute agendas and minutes; maintain records in the Trial Master File.

• Execute CTMS tasks, which include managing milestone dates, contact lists, enrollment forecasts, helpdesk requests, and remediation efforts.

• Prepare, assign, document, and oversee training specific to the study and its records; identify and escalate any training deficiencies.

• Create study-level SharePoint sites or shared workspaces and oversee access management.

• Establish project-specific email accounts and manage appropriate access permissions.

• Oversee user access to study systems and document periodic access assessments.

• Procure study supplies and initial study binders; prepare, compile, and coordinate the shipment of binders.

• 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, and CIOMS documentation.

• Aid in the translation of documents at the site level.

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

• Support the preparation, distribution, and reconciliation of study materials.

• Contribute to the production of study reports and updates, including site initiation, activation, and recruitment reports.

• Carry out other responsibilities as assigned by project leadership.

⛳️ Requirements

• Bachelor's degree (4-year) 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 similar positions.

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

• Professional-level command of spoken and written English.

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

• Strong customer service orientation, adaptability, teamwork, and attention to detail.

• Excellent interpersonal abilities.

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

• Exceptional written and verbal communication skills.

• Commitment to maintaining professionalism in alignment with Precision Principles.

🏝️ Benefits

• Comprehensive health and wellness programs.

• Professional development opportunities.

• Competitive salary and performance-based incentives.