Project Support Specialist

This is a fully remote position, open to applicants in Romania, +4 more countries.

📋 Description

• Develop and sustain project timelines utilizing MS Project or equivalent software; document and disseminate updates

• Organize both internal and external meetings; create and share agendas; record and distribute minutes; archive documents in the Trial Master File

• Manage data within the clinical trial management system, including milestones, contact lists, and enrollment projections; submit and monitor helpdesk tickets

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

• Create and supervise study-level SharePoint sites or similar collaborative workspaces and access

• Establish project-specific email accounts and ensure proper access management

• Oversee user access to study systems and document regular access evaluations

• Procure study supplies and initial study binders; prepare, compile, and coordinate shipping

• Maintain study trackers as instructed by project leadership

• Communicate with study sites, investigators, sponsors, and other stakeholders, including SUSARs, email blasts, and newsletters

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

• Aid in the translation of site-level documents adhering to local and regional standards

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

• Assist in the preparation, distribution, and reconciliation of study materials

• Support the creation of study reports and updates, encompassing country/site initiation, activation, and recruitment reports

• Carry out additional responsibilities as assigned by project leadership

• Provide cross-functional support for the effective management of assigned clinical studies

⛳️ Requirements

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

• At least 2 years of relevant experience as a Clinical Trial Assistant, Clinical Support Specialist, or in a similar role

• Proficiency in the Microsoft Office suite (Outlook, Word, Excel, and PowerPoint)

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

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

• Customer-focused attitude, adaptability, teamwork, and strong attention to detail

• Excellent interpersonal, written, and verbal communication abilities

• Competence to work independently as well as collaboratively within a team

• Dedication to executing duties in alignment with Precision Principles

🏝️ Benefits

• Fully remote work arrangement

• Regular full-time employment