
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.
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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.
• Assist the Project Management Division with coordination and conduct of project management activities • Create and distribute study-related documents and coordinate study activities • Assist with project management of clinical trial data in the EXCELSIOR™ cloud application environment • Perform data uploads and quality control functions • Maintain controlled documents, including Master Project Files • Provide support to clinical sites, reading centers, and clients using EXCELSIOR™ according to company and study-specific procedures and GCP • Organize and coordinate controlled documents and assist with study management • Develop, proofread, create, duplicate, and disseminate project and regulatory documents • Assist with quality review audit responses and training program development/implementation • Monitor work quality and completeness • Assist with study activities from start-up through closeout • Organize and prioritize assignments, anticipate problem areas, and solve problems creatively • Assist with study-specific processes, procedures, reports, and updates • Generate and email eligibility reports and notifications • Attend internal and sponsor project meetings via teleconference or face-to-face • Maintain study systems, procedures, site information lists, plans, study documents, and correspondence • Configure studies in EXCELSIOR™ and assist with configuration reviews • Manage and review site surveys and update EXCELSIOR™ for site registration • Provide guidance, training, and technical support to sponsors, CROs, clinical sites, and graders • Perform clinical site technician and equipment certification • Check in images and perform image quality control • Issue and review data query responses for completeness and accuracy • Review, categorize, and respond to customer support and complaint tickets • Follow up on EXCELSIOR™ access and review inactive user reports • Comply with company policies and Standard Operating Procedures
• BA or BS degree from a four-year college or university • Some related experience and/or training in administrative or customer service, preferably in a health care or service-related environment, or equivalent combination of education and experience • Preferred experience in clinical trial or project management in a related field • Strong interpersonal and organizational skills • Excellent attention to detail • Ability to follow direction, 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 to a team environment • Clear, concise, and effective oral and written communication • Ability to use hands; touch, finger and grasp, handle or feel, with repetitive motions • Ability to talk or hear • Ability to stand, walk and sit • Ability to reach with hands and arms, stoop, crouch, kneel and climb • Ability to frequently lift and/or move up to 10 pounds and occasionally lift and/or move up to 25 pounds • Close vision, color vision, peripheral vision, depth perception, and ability to adjust focus
• Flexible schedules • Remote opportunities • 401(k) Retirement Plan • Dental insurance • Health insurance • Paid Life insurance & AD&D • Paid Long-Term Disability • Paid Time Off (Vacation and Sick) • Paid 8 Holidays • Vision insurance
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