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

 

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.

NOTE: In providing such support to the CTMS team, the CTMS Support Analyst 2 is exposed to sensitive and confidential information (includes policy violations, compliance issues, investigations, audits, grievances, and matters that impact business decisions that hold a high degree of organizational risk).

 

The CTMS Support Analyst 2 will provide services under the direction of the CTMS Manager within the Clinical Research Services Office (CRSO). Employees in this class also make recommendations for and assist in the implementation of new techniques or procedures to improve methods of operations, strengthen controls, and effectively utilize resources.

The CTMS Support Analyst 2 position is distinguished from the CTMS Analyst I positions by the requirement for proficiency in complex research administration process as well as the use of data analysis methodologies. It is further distinguished from the lower level by planning and conducting improvement projects, which may cross program or organizational lines and require analyses of multiple variables within interrelated systems. Employees in this class may function as a team leader guiding and coordinating the work of several stakeholders involved in special projects. This level also requires significant coordination of variables between highly diversified or unrelated systems, including but not limited to the CTMS, Click Systems, Cognos, and other electronic systems.

 

The CTMS Support Analyst 2 provides support to the department by understanding and accurately applying policies and procedures to a variety of responsibilities, including incoming questions and issues; review of new study creations and transactions in the CTMS for completeness and basic compliance; creating metrics and data analysis; writing and updating policies, procedures, and other reports and documents; preparing training materials and providing training; and other projects and duties as assigned.

1. Assessment and Analysis*: 

• Assist in reviewing new study creation, activation and post-activation processes for clinical research studies submitted to the CTMS.
• 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, implementation, training and enhancement of electronic systems and departmental website content that support the CRSO. 

CTMS:   

• Perform initial review of studies created in the CTMS and respond to inquiries related to the CTMS. Use knowledge of federal, state, local and OHSU statutes, regulations, guidance, policies, procedures, Code of Conduct, best practices and systems to:
• Provide professional guidance, analysis and serve as a resource for other staff and the OHSU community. 
• Accurately review, analyze and provide initial approval/determination/resolution on submissions and inquiries in accordance with all applicable requirements and processes. 

Other duties, as assigned

• Bachelor’s degree

• Three years of experience administering or coordinating parts or subsets of a clinical trials project or program.

• Experience working with highly sensitive and confidential information and projects.

• Knowledge of clinical trials management business processes

• Advanced MS Office skills including creation of advanced templates, charts, graphs, tables, and forms for executive review.

• Ability to learn and understand a variety of software applications and data analytic procedures to support CRBO programs.

• Ability to appear at the workplace, ready to work, on a regular and consistent basis.

• Exceptional people skills.  Ability to interact in a positive, productive manner with others (demonstrating sensitivity, tact, and professionalism).

• Ability to deal effectively with difficult situations.

• Ability to analyze information and construct an action plan to effectively and cooperatively resolve issues.

• Ability to collaborate effectively and work both independently and in a team environment.

• Effective organizational abilities, oral and written communication skills, and interpersonal skills.

• Ability to operate and communicate effectively while meeting multiple deadlines and completing projects simultaneously. 

• Have or obtain within 2 years of hire applicable or related certification, such as SoCRA or ACRP

• Project/program coordination within a regulated setting. 
• Experience coordinating clinical trials using a CTMS.
• Complex academic medical center experience.
• Knowledge of CTMS functionality and best practices.
• SoCRA or ACRP certification

Please list work experience on resume in months and years.

Oregon Health & Science University values a diverse and culturally competent workforce. We are proud of our commitment to being an equal opportunity, affirmative action organization that does not discriminate against applicants on the basis of any protected class status, including disability status and protected veteran status. Individuals with diverse backgrounds and those who promote diversity and a culture of inclusion are encouraged to apply. To request reasonable accommodation contact the Affirmative Action and Equal Opportunity Department at 503-494-5148 or aaeo@ohsu.edu.