Project Coordinator I

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

📋 Description

• Support the Project Management Division in coordinating and executing project management tasks under direct supervision.

• Develop and disseminate study-related documents.

• Assist in managing clinical trial data within the EXCELSIOR™ cloud application.

• Conduct data uploads and perform quality control checks.

• Document and distribute meeting minutes.

• Maintain controlled documents, including Master Project Files.

• Offer assistance to clinical sites, reading centers, and clients in accordance with company and study-specific protocols and GCP guidelines.

• Organize and coordinate controlled documents along with office responsibilities.

• Aid in study management and development, including proofreading, creating, duplicating, and distributing project and regulatory documents.

• Address quality review audits and oversee work quality and completeness.

• Support study activities from initiation through to closeout.

• Organize and prioritize tasks while anticipating potential issues.

• Initiate Master Project Files and oversee project documentation.

• Generate and send eligibility notifications via email.

• Participate in internal and sponsor project meetings through teleconferencing or in-person attendance.

• Coordinate with Shipping and Receiving to verify the shipment and arrival of study materials.

• Review the EXCELSIOR™ study-specific configuration.

• Manage and evaluate site surveys, updating EXCELSIOR™ for site registration.

• Provide guidance and training to sponsors, CROs, clinical sites, and graders regarding EXCELSIOR™ functionality and technical support.

• Conduct image check-in and quality control processes.

• Issue and evaluate responses to data queries.

• Review, categorize, and address helpdesk customer support and complaint tickets.

• Perform and document routine reviews of inactive EXCELSIOR™ users.

• Adhere to company policies and SOPs.

• Advocate for quality, continuous improvement, safety, and customer satisfaction.

⛳️ Requirements

• A preferred bachelor's degree in a health-related, biological science, computer science, data entry, customer service, or business management field (or equivalent internal company experience).

• Strong interpersonal and organizational abilities.

• Exceptional attention to detail.

• Capability to follow instructions accurately.

• Ability to assess company needs and work independently.

• Proficiency in Microsoft Office applications.

• Willingness to learn company-specific software.

• Professional demeanor and presentation suitable for the workplace.

• Ability to engage and contribute effectively in a team setting.

• Clear, concise, and impactful oral and written communication skills.

• No specific licenses or certifications required.

• Capacity to perform the physical functions listed, including repetitive hand motions, standing, walking, sitting, reaching, stooping, crouching, kneeling, climbing, and lifting up to 25 pounds.

🏝️ Benefits

• 401k Retirement plan.

• Health Insurance coverage.

• Paid Holidays.

• Paid Long-Term Disability insurance.

• Paid Life Insurance.

• Paid Time Off.

• Flexible work schedules.

• Opportunities for remote work.