Sr. CRMS Coordinator

1 Inventa Place Silver Spring, MD 20910

Kids Are Our Everything.

Department 10574 CR Administration

Pay Range

$65,124.80 - $

The Sr. CRMS coordinator is responsible for the daily management and operations of the OnCore clinical research management system. They provide training and advisory services to end users and are a point of contact with the vendor. The Sr. CRMS coordinator is a member of the clinical research support team and helps to facilitate effective, efficient and compliant clinical research.

The Sr. Clinical Research Management Systems (CRMS) Coordinator will provide application support and administration in the maintenance of the electronic data systems (OnCore, Power Trials) utilized to support the administration of clinical trials. In addition, the position is responsible for training staff and faculty in the use of the systems and facilitating the adoption of these systems throughout Children's National. Clinical research experience and familiarity with database systems is recommended, including working knowledge of IRB, ICH/GCP guidelines, federal and state guidelines, and regulations and laws that govern research administration.

• Associate's Degree with at least 4 relevant years of experience (Required)
• Bachelor's Degree in a Sciences, Health Administration, Computer Science or other applicable discipline (Preferred)

• 3 years Prior clinical trials experience either as clinical research coordinator or in clinical research administration. (Required)
• 2 years Prior Experience with OnCore (Required)

• Use of computers and web-based applications in a security-focused environment.
• Critical thinking skills - ability to analyze business operations workflows, finding efficiencies, and implementing improvements.
• Excellent communication skills, ability to interact across the organization, ability to translate clinical research concepts and researcher needs to technical personnel and vice versa.
• Ability to develop training plans and materials and deliver training to end users.

• Consistently demonstrates adherence to the standards for the responsible conduct of research.
• Uses research funds and resources appropriately.
• Maintains confidentiality of data as required.
• Meets all annual job-related training and compliance requirements.

• Act as key point of contact for end users and vendor. Work with internal resources and/or vendor, where appropriate, to ensure issues are resolved in a timely manner. Facilitate OnCore Steering Committee, planning agenda, communicating with members, maintaining minutes, following up on action items.
• Works closely with the Research IT team to ensure that all interfaces between OnCore and other systems remain functional
• Provide support to end users including user training, new user activation, ongoing communication related to changes, functionality and status of respective applications.
• Develop communication and training materials for new and existing users. Ensures SOP's guidance documents and job aides are up to date and reflect current practices.
• Develops and annual training plan and schedule. Delivers training to new users as needed
• Coordinate the evaluation of upgrades on the test environment and provide feedback to vendor product support regarding functionality and to appropriate leaders regarding impact of upgrades.
• Evaluate and communicate to appropriate leaders and staff how upgrades may impact current workflows, policies and processes.
• Identify reporting requirements of research leadership and investigators/study teams and design, develop and disseminate validated standard and ad hoc reports as needed. Maintain a library of reports and update designs as necessary.
• Conduct internal monitoring of the system and provide a strategy for maintaining data integrity and to meet established standards of data entry into the system.
• Implement metrics to track organizational adoption for report to leadership.
• Participate in the creation of study protocol builds including calendars and budgets as needed.

• Comprehensive health coverage, including medical, prescription, infertility, and transgender health services.
• Generous paid time off, including vacation accrual from day one, sick leave, holidays, and a personal day.
• Financial wellness support, including a 401(k) plan and healthcare and dependent care spending accounts.
• Employer-paid life, AD&D, and long-term…