Project Support Specialist

This is a fully remote position, open to applicants in Romania.

📋 Description

• Develops and maintains the project timeline using MS Project or a similar platform. Ensures that updates are recorded and communicated appropriately to study team members.

• Organizes both internal and external meetings, aids in the preparation and distribution of agendas, takes minutes during meetings, circulates these minutes, and files them in the Trial Master File.

• Conducts various tasks within the Clinical Trial Management System (CTMS) including tracking study milestone dates, updating contact lists, managing enrollment forecasts as necessary, and submitting helpdesk requests to ensure timely resolution.

• Prepares, assigns, and documents training specific to the study in the relevant systems; oversees the upkeep of training records. Identifies any training gaps and works with relevant team members or escalates issues when necessary.

• Creates a study-level SharePoint site or a comparable shared workspace, ensuring appropriate access for study team members, sponsors, and other stakeholders as needed.

• Establishes project-specific email accounts and manages access for study team members.

• Oversees user access to study systems by submitting user requests to the Help Desk or similar services, periodically reviewing team member access, and documenting access reviews.

• Procures study supplies and addresses inquiries related to these supplies.

• Orders initial study binders, collects, compiles, and prepares them for shipping to the designated locations via printing vendors.

• Maintains various study trackers as required and directed by the Project Manager, Clinical Trial Manager, or other project leaders.

• Sends communications to study sites, investigators, and other parties as directed by the Project Manager, Clinical Trial Manager, or other Project Leadership, which may include SUSARs, email blasts, newsletters, and other necessary information.

• May assist in the distribution and tracking of IND Safety Reports/SUSARS/CIOMS according to the protocols established by the study team in the project plan, potentially under the guidance of Safety staff.

• May help facilitate the translation process for site-level documents as required, adhering to local and regional standards.

• May serve as the primary contact for project-related inquiries from team members, Sponsors, and third-party vendors.

• Aids in the preparation, distribution, and reconciliation of study materials during relevant phases of the study (e.g., Operations Manual, ISF, patient cards, etc.) as applicable.

• May assist team leaders in producing various study reports and updates (e.g., country/site initiation, activation, recruitment).

• Performs additional responsibilities as assigned by the Project Manager, Clinical Trial Manager, or other Project Leadership.

⛳️ Requirements

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

• At least 2 years of pertinent 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).

• Strong customer service orientation; exhibits flexibility, teamwork, and meticulous attention to detail.

• Ability to communicate effectively in both verbal and written English (professional proficiency required).

• Basic understanding of ICH-GCP, Precision SOPs, and relevant regulatory guidelines.

• Demonstrates strong interpersonal skills.

• Shows high levels of self-motivation, attention to detail, and the ability to work independently as well as collaboratively in a team setting.

• Excellent written and verbal communication abilities.

• Committed to upholding professional standards consistent with Precision Principles.

🏝️ Benefits

• Health insurance

• 401(k) matching

• Flexible work hours

• Paid time off

• Remote work options