| Job Description Summary: | The Senior Applications Administrator, Clinical Research Programs functions as the Subject Matter Expert for Clinical Research computer applications at for the GW SMHS and reports within the Office of the Dean. This includes the Clinical Trial Management System (CTMS)-Oncore™, Eval, Oncore™- Electronic Data Capture (EDC), Florence eBinders (eRegulatory system and econsenting module) and other systems. Provides application support for users within the institution and external study sites and collaborators. This position will collaborate with vendors, customers, and other IT professionals to evaluate requirements for new features, modules, and applications and also install troubleshooting and evaluate interfaces between systems. Performs project management function (when necessary) for application users, technical support personnel, clinical research administration, and vendor(s) during all system installations, issues, interfaces, and enhancements.
The Senior Applications Administrator, Clinical Research Programs is owner of the suite of systems as well as the Florence eBinders system. This role is the subject matter expert of the software applications, providing training and documentation to users, and also liaises with vendor(s) and other information technology resource partners at the university. This position gathers user requirements, implements upgrades and minor modifications, troubleshoots errors/future needs, and provides feedback with vendors with limited supervision. This role ensures system configuration and settings appropriately support endusers and comply with the system integration that have been enabled. These roles are often single incumbent in nature in a unit and may work with other application coordinators/assistants who support their efforts. Other responsibilities include:
- While working with limited supervision, performs Clinical Research application administrative functions, including but not limited to: security, user access, the addition of study sites, report creation and archiving policies and procedures. Participates and contributes in Clinical Research application collaborations and forums.
- Serves as the leader for Integrating the CTMS (and related products) with Enterprise software systems within the GWU and GWU-MFA organizations.
- Install, maintain and upgrade the Florence eBinders suite of products. Integrate these systems with other software systems used in clinical research with the GWU Clinical Research Enterprise.
- Provides user support to the research and administrative staff of the research center and participating satellite study sites.
- Maintain Oncore EDC and Florence eBinders system (including econsenting module) in validated state to be compliant with the 21 CFR 11 Federal Regulations.
- Provide personalized training to new and existing users throughout the Clinical Research Enterprise.
- Create and maintain training materials for the related CTMS applications. These include work aids, Standard Operating Procedures, Policies and video tutorials.
- Maintain Oncore website (in collaboration with the communications department) and sharepoint site to provide end users with the available resources to make them successful.
- Oversees upgrades to the software system (up to 3x per year) for each module. This includes performing the risk assessment and determining the threat level for each upgrade. The risk level will determine the degree of validation testing required post upgrade. Assigns user tasks for on-site evaluation of new upgrades in the test environment and provides feedback to developers regarding the new functionality.
- Works with users to educate and identify available vendor reports and/or develop custom reports, as needed. This includes working with GW IT and the vendor as required to create custom reports, script fixes, interface issues and upgrade installs.
- Acts as the resource to problem solve, develop user consensus, measure and work to improve user satisfaction.
- Prioritizes and specifies product enhancements and requirements to Clinical Research application vendor personnel.
- Works with vendor(s) as needed to notify of or correct performance issues, product defects, script fixes, enhancements, upgrades, and other institutional or external site user issues.
- Serves as the institutional representative on Clinical Research application vendor committee(s) for software development and customer support. Creates and updates of SOPs utilizing applications initially and during upgrades.
- Oversees administrative aspects of the Clinical Research application such as adding new options to pick lists, new staff members and institutions.
- Assists in the generation of standard summaries for core grant, if requested.
- Perform Quality Control/Assurance activities to ensure that research records are complete and appropriate.
- Completes special projects or tasks as required
Performs other related duties as assigned. The omission of specific duties does not preclude the supervisor from assigning duties that are logically related to the position.
|
| Minimum Qualifications: | Qualified candidates will hold a Bachelor’s degree in an appropriate area of specialization plus 2 years of relevant professional experience, or, a Master’s degree or higher in a relevant area of study. Degree must be conferred by the start date of the position. Degree requirements may be substituted with an equivalent combination of education, training and experience. |
