Provide support to the Research Integrity department and in providing such support 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 Integrity Analyst 2 will provide services under the direction of the IRB and Conflict of Interest programs within the Research Integrity department. 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.
Conflict of Interest (CoI)
- Perform initial review of CoI disclosures and respond to inquiries related to CoI. Use knowledge of federal, state, local, and OHSU statutes, regulations, guidance, policies, procedures, Code of Conduct, best practices, and systems to:
- Provide professional guidance and analysis; serve as 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.
Assessment and analysis (within both CoI and IRB programs)
- Assist in pre-review, review, approval and post-approval processes on research related and/or eIRB submissions.
- Detailed pre-screening of submissions and proposed changes, identify problematic areas and communicate directly with internal and external personnel to ensure accurate and complete study submissions.
- Fielding, triaging and responding to incoming questions.
- Performs analytical and business tasks serving multiple functions in support of the IRB/HRPP/Research Integrity Office, including taking meeting minutes and providing high-level of support to IRB, other areas of the Research Integrity Department and Leadership.
- Maintain high level of confidentiality and use of sound independent judgment.
- Using knowledge of policies, procedures, and technologies, review, analyze, and
- Resolve/finalize all responsibilities in accordance with all applicable requirements and processes. This includes using sound judgment, as well as analytical, organizational, and time management skills, to conduct independent, accurate and timely review of submissions, transactions, inquiries, and projects, as assigned.
- Development and maintenance of policies and procedures.
- Appropriately and effectively handles, prepares, and manages OHSU sensitive and confidential communications, information and data related to Research Integrity projects and issues.
- Independently prepare (drafts/edits, finalizes) 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.
- Collect, manage, analyze, query, and generate reports for data/metrics from a variety of sources using applicable technologies. Summarize analysis of data for Research Integrity teams and identify areas to improve reporting and data integrity.
Training and communication
- Backup, support and training to Integrity Analyst 1 position(s)/other position(s) in the Research Integrity department as needed.
Continuous Quality Improvement
- Participate in continuous quality improvement initiatives in partnership with Research Integrity department leadership.
- Identify weaknesses and deficiencies, and provide input to Research Integrity department leadership on how to enhance the quality and efficiency of the work performed.
Workflow Planning and Improvement
- Consults with cross-functional stakeholders to initiate workflow studies for regulatory compliance submissions, identify improvement opportunities, define scope, purpose, objectives, time frames, and resource requirements.
- Utilizes techniques for fact finding and types of information required.
- Conducts on site interviews with inter and intra-departmental personnel to observe and discuss operations.
- Reviews applicable laws and regulations to ensure compliance.
- Evaluates collected information for accuracy and adequacy.
- Serves as team leader providing guidance to other professional/technical team members in workflow development.
Other duties as assigned.