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, implementation, training and enhancement of electronic systems and departmental website content that support the CRSO.

CTMS 

• Perform initial financial setup 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.

Required Qualifications:

• Bachelor’s degree.
• Three years of experience administering or coordinating parts or subsets of a clinical trials project or program financial management.
• Experience working with highly sensitive and confidential information and projects.
• Knowledge of clinical trials financial 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 CRSO 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.

Preferred Qualifications:

• Project/program financial administration for clinical research within an academic institution.
• Experience coordinating clinical trials using a CTMS.
• Complex academic medical center experience.
• Knowledge of CTMS functionality and best practices.
• Experience with clinical research budgets, invoicing, and payment reconciliation.
• SoCRA or ACRP certification.

Additional Details:

Please list work experience on resume in months and years.

 

This position requires the ability to work remotely, and the ability to report to the OHSU Portland campus for regular and ad hoc meetings and assignments as needed.

 

Benefits 

• Healthcare for full-time employees covered 100% and 88% for dependents.
• $50K of term life insurance provided at no cost to the employee.
• Two separate above market pension plans to choose from.
• Paid time off - 208 hours per year, prorated for part-time.
• Extended illness bank - 64 hours per year, prorated for part-time.
• 9 paid holidays per year.
• Substantial Tri-Met and C-Tran discounts.
• Employee Assistance Program.
• Childcare service discounts.
• Tuition reimbursement.
• Employee discounts to local and major businesses.

Why apply to OHSU?: We are Oregon's only public academic health center. In addition to caring for patients, we lead groundbreaking research. We also train the next generation of health care professionals. As Portland's largest employer, we give you opportunities to learn and advance in a system of hospitals and clinics across Oregon and Southwest Washington. All are welcome. OHSU welcomes people of all ages, ethnicities, genders, national origins, religions and sexual orientations. We are striving to build an anti-racist, multicultural institution and encourage people with diverse backgrounds to apply. To request reasonable accommodation, contact askhr@ohsu.edu

Operates an academic health center and research university.