Since 2001 Hansell Tierney has been one of the premier staffing and recruiting companies in Seattle Washington. As a Certified Women’s Business Enterprise (WBE), Hansell Tierney was created to serve and staff Northwest companies by doing things the right way, not just the easiest. We strive to do better by partnering with candidates, treating your experience as one of our own, providing our candidates with interesting local opportunities, and handling every relationship with the highest level of customer service possible. Our business is built on the deep understanding of the job market and the ability to over-deliver on our promises.
We are currently helping our client, a biopharmaceutical company in Seattle, with a search for a Clinical Systems Administrator,
Duration - 12 month contract
Location - Seattle, WA
US citizens and those authorized to work in the US are encouraged to apply
Work sponsorship is not available at this time
The Clinical Systems Administrator (CSA) supports cloud-based electronic systems and software such as the Clinical Trial Management System (CTMS), Trial Master File (TMF), monitoring visit report (MVR) system, payment system, and Clinical Operations SharePoint sites. The CSA works closely with external vendors, Study Teams, Data Management, Finance, remote-based staff, and Clinical Operations leadership to support electronic systems infrastructure, systems training, inspection readiness, Biologics Licensing Application (BLA) preparation, good financial practices, and team deliverables.
ESSENTIAL DUTIES & RESPONSIBILITIES
Electronic Clinical Systems and Software Support
Clinical Operations and Study Team Support
- Coordinate cross-functional evaluation, selection, and implementation of clinical systems or software.
- Ensure thorough understanding of contracted scope, timeline, and budget for clinical systems and software.
- Monitor budget compliance and inform Clinical Operations leadership of any potential out-of-scope work.
- Assist in gathering system requirements, configuring systems, and testing new systems or system upgrades.
- Supervise development of test data, system testing and documentation for all phases of clinical systems life cycles.
- Serve as the clinical systems super-user and work with Study Managers and Clinical Operations leadership to establish appropriate workflows.
- Facilitate appropriate cross-training to ensure adequate coverage and continuous operations during absences.
- Liaise between Juno Clinical Operations, Data Management, Finance, Quality Assurance, IT and external vendors on systems-related issues.
- Escalate critical systems issues to Clinical Operations leadership.
- Maintain appropriate user access, roles, and security based on company policies and industry best practices.
- Manage day-to-day administration of clinical systems and software applications
- Create and facilitate group and one-on-one clinical systems training, coaching and user support to in-house, remote and CRO-based) staff.
- Support system enhancements, process improvement, change control, and system validation.
- Meet regularly with system stakeholders to assess and modify (as applicable) clinical systems.
- Work with study teams to identify and administer study specific projects within clinical systems.
- Schedule and perform system reviews/audits, report findings to department leadership, and work with appropriate stakeholders to resolve findings.
- Create and update standard operational procedures (SOPs) and work instructions for assigned systems.
- Record meeting notes/minutes, produce action items lists, and distribute to relevant team members or department leadership.
- Distribute study metrics and key performance indicators (KPIs) to designated internal and external stakeholders.
- Communicate project updates, status reports and other information to Clinical Operations through oral and written methods. May also present information at meetings.
- Lead TMF set-up, structure, and completeness report configurations. Develop the list of expected documents and perform associated gap analyses.
- Communicate documentation deficiencies to study team members and (when requested) work with site or remote staff to reconcile deficiencies
- Record milestones, investigator, clinical site,vendor and/or contractor information in the CTMS.
- Lead study documentation/tracking in clinical systems and coordinate with study teams to resolve discrepancies.
- Implement, support and maintain collaborative workspaces (e.g., SharePoint) for study teams.
- Review, reconcile and process clinical site/vendor invoices
- 2+ years of clinical operations support in a Clinical Trial Assistant or Clinical Research Associate position.
- BS or BA in Life Sciences or related discipline.
- Competencies in clinical operations, cross-functional study team support, electronic system configuration, and PC based software