Clinical Trials Management Systems Coordinator

Silver Spring, Maryland-Silver Spring
Sep 10, 2020
Oct 15, 2020
Full Time
The Clinical Trials Management Systems Coordinator will provide application support and administration in the implementation and 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.


Minimum Education
Associate's Degree - Sciences, Health Administration, Computer Science or equivalent (Required)

Bachelor's Degree (Preferred)

Minimum Work Experience

3 year prior clinical trials experience either as clinical research coordinator or in clinical research administration.

Specific Requirements and Preferences
Prior Experience with OnCore and/or Cerner Power Trials . (Preferred)
Experience with other CTMS or data capture systems in support of clinical research is a plus. (Preferred)
Previous experience using reporting tools such as Jaspar Studios, SSRS. (Preferred)
Clinical trials experience either as clinical research coordinator or in clinical research administration. (Preferred)

Required Skills/Knowledge
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.

Functional Accountabilities

1. Understand and provide recommendations for application set up to align with organizational goals; responsible for coordinating details about current state along with organizational leadership to ensure institutional goals are met.
2. Assist with data migration related activities
3. Responsible for testing and providing feedback related to testing to project committee.
4. Collaborate with OnCore and Power Trials/Cerner end uses, technical support, key stakeholders and organizational leadership to ensure institutional goals are met.
5. Participate in the development of training materials for all end users.
6. Lead training sessions for all end users

Post - Implementation/Ongoing activities
1. 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.
2. Provide support to end users including user training, new user activation, ongoing communication related to changes, functionality and status of respective applications.
3. Develop communication and training materials for new and existing users.
4. 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.
5. Evaluate and communicate to appropriate leaders and staff how upgrades may impact current workflows, policies and processes.
6. 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.
7. 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.
8. Implement metrics to track organizational adoption for report to leadership.
9. Participate in the creation of study protocol calendars.

Children's National Health System is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law.

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