Project Coordinator I

Job not on LinkedIn

🔥 13 hours ago

🧀 Wisconsin – Remote

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⏰ Full Time

🟡 Mid-level

🟠 Senior

👷‍♀️ Project Manager

👻 Ghost score 12%

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Logo of MERIT CRO

MERIT CRO

51 - 200 employees

Founded 2012

🏥 Healthcare

💊 Pharmaceuticals

☁️ SaaS

💰 $1.1M Venture Round - MERIT on 2023-07

Healthcare • Pharmaceuticals • SaaS

MERIT CRO is an innovative clinical endpoint expert and contract research organization that partners with CROs, pharmaceutical and biotech sponsors to provide centralized endpoint services for global clinical trials. It focuses on therapeutic areas including ophthalmology, oncology, respiratory and cardiology and offers specialized services such as reading center services, BCVA certification, centralized image storage, endpoint assessments, and clinical operations support. MERIT also provides a cloud-based software platform (EXCELSIOR) for real-time, single-system access to trial endpoints and emphasizes quality and compliance evidenced by ISO 13485 and ISO 27001 certifications and FDA 510(k) clearance. The company positions itself as a B2B service provider aimed at improving the reliability and efficiency of imaging- and endpoint-driven clinical trials.

📋 Description

• Assist the Project Management Division with coordination and conduct of project management activities under direct supervision • Create and distribute study-related documents • Support management of clinical trial data in the EXCELSIOR™ cloud application environment • Perform data uploads and quality control functions • Record and distribute meeting minutes • Maintain controlled documents, including Master Project Files • Provide support to clinical sites, reading centers, and clients according to company and study-specific procedures and GCP • Organize and coordinate controlled documents and office tasks • Assist with study management and development, proofreading, creation, duplication, and dissemination of project and regulatory documents • Respond to quality review audits and monitor work quality and completeness • Support study activities from start-up through closeout • Organize and prioritize assignments and anticipate problem areas • Initiate Master Project Files and maintain project documents • Generate and email eligibility notifications • Attend internal and sponsor project meetings via teleconference or face-to-face • Coordinate with Shipping and Receiving to confirm shipment and receipt of study materials • Review EXCELSIOR™ study-specific configuration • Manage and review site surveys and update EXCELSIOR™ for site registration • Provide guidance and training to sponsors, CROs, clinical sites, and graders on EXCELSIOR™ functionality and technical support • Perform image check-in and quality control • Issue and review data query responses • Review, categorize, and respond to helpdesk customer support and complaint tickets • Perform and document periodic reviews of inactive EXCELSIOR™ users • Comply with company policies and SOPs • Promote quality, continuous improvement, safety, and customer satisfaction

🎯 Requirements

• Preferred bachelor’s degree in a health-related, biological science, computer science, data entry, customer service, or business management field (or internal company work experience) • Strong interpersonal and organizational skills • Excellent attention to detail • Ability to follow direction • Ability to assess Company needs and work independently • Proficiency in Microsoft Office software • Ability to learn Company specific software • Professional attitude and image appropriate for the work environment • Ability to participate and contribute in a team environment • Clear, concise, and effective oral and written communication • No licenses or certifications required • Ability to perform the listed physical functions, including repetitive hand motions, standing, walking, sitting, reaching, stooping, crouching, kneeling, climbing, and lifting up to 25 pounds

🏖️ Benefits

• 401k Retirement • Health Insurance • Paid Holiday • Paid Long-Term Disability insurance • Paid Life Insurance • Paid Time Off • Flexible schedules • Remote opportunities

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