MERIT CRO, Inc.

MERIT CRO, Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities.

Project Coordinator I

Location

United States

Posted

2 days ago

Salary

0

Seniority

Mid Level

No structured requirement data.

Job Description

Project Coordinator I

MERIT CRO, Inc.

Role Description MERIT is seeking a full-time Project Coordinator to work under direct supervision, assisting the Project Management Division with the coordination and conduct of project management activities, including the creation and distribution of study-related documents. Primary functions include: - Supporting the management of clinical trial data in the EXCELSIOR™ cloud application environment - Performing data upload and quality control functions - Recording and distributing meeting minutes - Maintenance of controlled documents including Master Project Files - Providing support functions for clinical sites, reading centers, and clients according to company and/or study-specific procedures and Good Clinical Practices (GCP) ESSENTIAL DUTIES AND RESPONSIBILITIES: - Administrative Duties: - Assist in the management of office tasks, including organization and coordination of controlled documents - Assist with all aspects of study management - Assist in the development of the project and regulatory documents; includes proofreading of documents - Assist in the creation, duplication, and dissemination of documents - Assist with responses to quality review audits - Monitor own work to ensure quality and completeness - Study-Related Duties: - Assist with all study activities from start-up through close out - Organize and prioritize work assignments to complete assignments and tasks on time, with quality, and has the ability to anticipate problem areas in advance - Apply creative approaches and ideas to solve problems maximizing the effective use of appropriate resources - Initiation of Master Project File and maintenance of project documents - Generate and email eligibility notifications - Attend project meetings internally and with the sponsor (via teleconference or face-to-face) throughout the project - Communicate with Shipping and Receiving Department to confirm shipment and receipt of study-related materials at the designated address - Software-related Duties: - Understand the EXCELSIOR™ product, protocol, and conduct of clinical trials in sufficient detail to be able to adequately discuss tasks with study team members - Assist with the review of EXCELSIOR™ study-specific configuration - Manage and review site surveys; update EXCELSIOR™ for site registration - Assist with providing guidance and training to sponsors, CROs, clinical sites, and graders on the use of EXCELSIOR™, including software functionality and technical support - Image check-in and quality control - Issue and review data query responses to ensure completeness and accuracy of response relative to other data - Review, categorize, and respond to customer support and complaint tickets in the helpdesk application - Perform and document periodic review of inactive users in EXCELSIOR - Other: - Comply fully with company policies and Standard Operating Procedures (SOPs) - Other responsibilities may be assigned as required Qualifications - 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, assess Company needs, and work independently - Computer skills to include proficiency in Microsoft Office software and ability to learn Company specific software - Ability to project a professional attitude and image appropriate for the work environment - Ability to participate and contribute in a team environment as a team member - Oral and written communication is clear, concise, and effective Requirements - None Benefits - 401k Retirement - Health Insurance - Paid Holiday - Paid Long-Term Disability insurance - Paid Life Insurance - Paid Time Off Company Description MERIT CRO, Inc. is a global clinical trial endpoint expert specializing in multiple therapeutic areas. We’re committed to making a difference and are seeking talented people to join our team. Collaboration and customer focus are at the core of everything we do. We value diversity and are interested in people with drive, dedication, and creative problem-solving skills. We offer flexible schedules and remote opportunities.

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