Clinical Trials Management System Analyst 2 (Integrity Analyst 2)

Department Overview

The Clinical Research Services Office functions as a central service office, overseeing industry sponsored research contracting, clinical research billing compliance, OHSU's clinical trials management system, and federal reporting compliance. Additionally, the CRSO helps to set some of the standards and policies for the conduct of clinical research at OHSU. We also seek to engage clinical research staff in community building, training and education through partnering with other OHSU departments and teams via the Clinical Research United (CRU) initiative.

 

To learn more, please visit https://www.ohsu.edu/clinical-research-services-office

Function/Duties of Position

The CTMS Support Analyst 2 works within the Clinical Trials Management Team. The team oversees and facilitates the use of the system in conjunction with clinical research at OHSU. The team ensures compliance with OHSU policies and procedures to accurately track all patient activity when involved in clinical research as this is a key element directly tied to billing compliance and revenue integrity for the organization. This position supports OHSU’s Clinical Trial Management System (CTMS), known more broadly as the Clinical Research Management System (CRMS). The CTMS is used for financial management, study and subject tracking, revenue tracking, billing compliance and reporting for OHSU clinical trials involving human subjects.   

 

Assessment and Analysis

• Assist in reviewing new study creation, activation and post-activation processes for clinical research studies submitted to the CTMS.
• Enter financial study information in the CTMS per study contract and/or finalized study budget.
• Detailed review of new study creation and proposed changes, identify problematic areas and communicate directly with internal and external personnel to ensure accurate and complete study creation within the CTMS.
• Field, triage and respond to incoming questions.
• Perform analytical and business tasks serving multiple functions in support of the CTMS, CRBO and CRSO departments, including taking meeting minutes and providing high-level of support to the CTMS manager, other areas of the CRSO and Leadership.
• Using knowledge of policies, procedures, and technologies, will review, analyze, resolve and complete all responsibilities in accordance with all applicable requirements and processes. This includes maintaining a high level of confidentiality and using sound judgment, as well as analytical, organizational, and time management skills, to conduct independent, accurate and timely review of new study creation, transactions, inquiries, and projects, as assigned.
• Develop and maintain policies and procedures.
• Appropriately and effectively handle, prepare, and manage OHSU sensitive and confidential communications, information and data related to CRSO projects and issues.
• Independently prepare (draft/edit/finalize) a variety of correspondences, reports, presentations, spreadsheets, statistics and forms, including confidential and sensitive materials for research leadership and/or federal, state and local authorities.
• Perform validation of data in the CTMS production and staging environments to ensure that data is accurate, consistent and complete.
• Collect, manage, analyze, query and generate reports for data/metrics from a variety of sources using applicable technologies. Summarize analysis of data for CRSO teams and identify areas to improve reporting and data integrity.

Training and communication

• Provide backup, support and training within the CTMS team as needed.

Continuous Quality Improvement

• Participate in continuous quality improvement initiatives in partnership with the CTMS manager.
• Identify weaknesses and deficiencies, provide input to CTMS manager on how to enhance the quality and efficiency of the work performed.

Workflow Planning and Improvement

• Consult with cross-functional stakeholders to initiate workflow studies for data compliance, identify improvement opportunities, define scope, purpose, objectives, timeframes, and resource requirements.
• Utilize techniques for fact-finding and types of information required.
• Conduct on-site interviews with inter- and intra-departmental personnel to observe and discuss operations.
• Review applicable laws and regulations to ensure compliance.
• Evaluate collected information for accuracy and adequacy.
• Serve as team leader providing guidance to other professional/technical team members in workflow development.

Technology liaison

• Provide functional expertise to ITG, department and end users on the use of, implementatio