FSP Project Coordinator I

🔥 14 hours ago

🌲 North Carolina – Remote

🌲 North Carolina – Remote

💵 $62k - $70k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 0%

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Fortrea

WebsiteLinkedInAll Job Openings

10,000+ employees

🏥 Healthcare

🧬 Biotechnology

💊 Pharmaceuticals

Healthcare • Biotechnology • Pharmaceuticals

Fortrea is a global clinical research organization (CRO) specializing in providing comprehensive clinical development services to biopharma and MedTech companies. With over 30 years of experience, Fortrea offers a range of services including clinical pharmacology, phase I-IV study management, regulatory strategy, market access, and more. They focus on advancing healthcare innovation by integrating data and scientific expertise to deliver tailored solutions that enable faster decision-making and improve patient outcomes, especially in the realm of cell and gene therapy programs, as well as various therapeutic areas like oncology, cardiovascular, and infectious diseases.

📋 Description

• Perform diverse coordination and administrative tasks and activities • Review and support logistics and operational management of Business Operations processes • Identify challenges, resolutions, and process improvement initiatives • Provide analytical and specialized support to executives, managers, and staff • Coordinate, track, and manage budgets, metrics, vendor compliance/risk, new-hire and leaver activities, and vendor/client/team meetings • Process, analyze, and graphically display Business Operations data • Support ad hoc activities for Business Operations functional leadership • Manage the Business Operations Core Training Matrix and track mandatory training compliance • Prepare correspondence, presentations, reports, letters, and other documents • Maintain confidentiality of critical documents • Manage complex assignments and projects, conduct research, and perform data analysis • Coordinate and compile Business Operations Monthly Reporting • Arrange meetings, agendas, slides, minutes, hospitality, business travel, presenters, materials, and action items • Facilitate WebEx and Blue Jeans meetings • Arrange and oversee Business Operations training administration and compliance reporting • Maintain filing systems according to Records Retention policies, including CVs, job descriptions, and organizational charts • Maintain departmental trackers, distribution lists, continuity contact lists, and SharePoint/Yammer sites • Create and maintain department newsletters • Support day-to-day operational management and execution of assigned clinical trials • Maintain clinical trial information in tracking tools, databases, and operational systems • Assist with study-specific plans, essential trial documents, and operational processes throughout the study lifecycle • Support study startup, site feasibility, site activation readiness, study system setup, maintenance, and closeout • Coordinate communications with investigative sites, investigators, vendors, and cross-functional teams • Assist with vendor onboarding, oversight, deliverable tracking, issue resolution, and study-requirement communications • Coordinate Trial Master File document collection, review, filing, and compliance activities • Support clinical data review, data cleaning, and study metric tracking • Coordinate investigator, site, and study team training and compliance documentation • Contribute to patient-focused initiatives supporting participant recruitment, retention, and trial success • Perform other duties as needed or assigned

🎯 Requirements

• University/college degree-level education in Life Sciences, Business Studies, or related field, or equivalent experience • Minimum of three years relevant coordination/administration experience in a clinical research setting in a pharmaceutical company/CRO • Minimum of 3 years of project coordinator, project administrator, executive administrative assistant, or related experience • Valid Driver’s License • Professional interaction with internal and external individuals at all levels • Ability to manage time and meet deadlines independently and efficiently • Advanced proficiency in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook) and Internet • Ability to use applications, run reports, manage spreadsheets, email, and use the internet • Outstanding communication, presentation, and keyboarding skills • Ability to coordinate activities among departments and outside parties in a corporate team environment • Strong prioritization, organization, time management, and attention-to-detail abilities • Critical-thinking and independent problem-solving skills • Excellent oral and written communication with team members, clients, vendors, and management • Demonstrated understanding of clinical research processes, including study startup, conduct, monitoring support, maintenance, and closeout • Working knowledge of ICH-GCP guidelines, clinical research regulations, and industry standards • Knowledge of clinical trial documentation requirements, Trial Master File (TMF) management, and quality compliance practices • Experience with clinical trial management systems, electronic trial master files, and study tracking tools preferred • Ability to sit for extended periods and operate a vehicle safely • Ability to access and use in-house and off-the-shelf computer software • Ability to lift and carry 15–20 lbs • Regular and consistent attendance • Varied hours may be required

🏖️ Benefits

• EEO & accommodations support • Regular and consistent attendance • Varied hours may be required