FSP Project Coordinator I

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

📋 Description

• Execute a variety of coordination and administrative duties and responsibilities.

• Assess and assist with the logistics and operational management of Business Operations processes.

• Recognize challenges, propose solutions, and initiate process improvement strategies.

• Offer analytical and specialized support to executives, managers, and staff members.

• Oversee, track, and manage budgets, metrics, vendor compliance/risk, activities related to new hires and departures, and vendor/client/team meetings.

• Process, analyze, and visually represent Business Operations data.

• Assist with ad hoc tasks for Business Operations functional leadership.

• Manage the Business Operations Core Training Matrix and monitor mandatory training compliance.

• Draft correspondence, presentations, reports, letters, and various documents.

• Ensure confidentiality of sensitive documents.

• Handle complex assignments and projects, conduct research, and carry out data analysis.

• Coordinate and compile Monthly Reporting for Business Operations.

• Organize meetings, including agendas, slides, minutes, hospitality, business travel, presenters, materials, and action items.

• Facilitate WebEx and Blue Jeans meetings.

• Organize and oversee the administration and compliance reporting of Business Operations training.

• Maintain filing systems in accordance with Records Retention policies, which include CVs, job descriptions, and organizational charts.

• Keep departmental trackers, distribution lists, continuity contact lists, and SharePoint/Yammer sites updated.

• Create and manage department newsletters.

• Support the daily operational management and execution of designated clinical trials.

• Maintain clinical trial data in tracking tools, databases, and operational systems.

• Assist with study-specific plans, essential trial documents, and operational workflows throughout the study lifecycle.

• Aid in study startup, site feasibility assessments, site activation readiness, study system configuration, upkeep, and closure.

• Coordinate communications with investigative sites, investigators, vendors, and cross-functional teams.

• Support vendor onboarding, oversight, deliverable tracking, issue resolution, and study-requirement communications.

• Manage the collection, review, filing, and compliance activities of Trial Master File documents.

• Assist with clinical data review, data cleaning, and tracking study metrics.

• Coordinate training and compliance documentation for investigators, sites, and study teams.

• Contribute to patient-centered initiatives that support participant recruitment, retention, and trial success.

• Perform additional duties as required or assigned.

⛳️ Requirements

• Bachelor's degree or equivalent in Life Sciences, Business Studies, or a related field, or relevant experience.

• At least three years of relevant coordination or administration experience in a clinical research environment within a pharmaceutical company or CRO.

• Minimum of three years of experience as a project coordinator, project administrator, executive administrative assistant, or in a similar role.

• Possession of a valid Driver’s License.

• Professional engagement with individuals at all levels, both internal and external.

• Capability to manage time effectively and meet deadlines independently and efficiently.

• Advanced skills in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Internet usage.

• Proficient in using applications, generating reports, managing spreadsheets, emailing, and navigating the internet.

• Exceptional communication, presentation, and typing skills.

• Skillful in coordinating activities between departments and external parties in a corporate team setting.

• Strong abilities in prioritization, organization, time management, and attention to detail.

• Critical thinking and independent problem-solving capabilities.

• Excellent oral and written communication skills with team members, clients, vendors, and management.

• Proven understanding of clinical research processes, including study startup, execution, monitoring support, maintenance, and closure.

• Familiarity with ICH-GCP guidelines, clinical research regulations, and industry standards.

• Knowledge of clinical trial documentation requirements, management of Trial Master Files (TMF), and quality compliance practices.

• Experience with clinical trial management systems, electronic trial master files, and study tracking tools is preferred.

• Ability to sit for extended periods and operate a vehicle safely.

• Capability to access and utilize both in-house and off-the-shelf software.

• Ability to lift and carry weights between 15–20 lbs.

• Consistent and regular attendance is required.

• Flexibility in working hours may be necessary.

🏝️ Benefits

• EEO & accommodations support.

• Regular and consistent attendance.

• Flexibility in working hours may be necessary.