POSITION SUMMARY:

Under the general direction of the Assoc Director, Clinical Research Revenue Recovery & Billing or designee, the Clinical Research Operations Analys Open Rank is responsible for various operational functions associated with the timely, compliant execution of UMMS clinical research activities.

ESSENTIAL FUNCTIONS:

Clinical Research Management System (CTMS) Operations

• Analyzes, evaluates and maintains clinical research protocols, budgets and contract amendments within the CTMS.
• Interprets clinical research protocols, defining the CTMS payments configuration and business processes that support study team workflows, which includes calendar building, and budget entry.
• Works closely Office of Clinical Research coverage analysts as needed to ensure operational compliance and consistency across clinical research protocols.
• Conducts analytical quality assurance review and analysis of CTMS initial data and completes OCR sign off within the CTMS for all newly awarded protocols.
• Analyzes study calendar revisions within the CTMS that impact invoicing and revenue recovery.
• Completes appropriate, detailed, analytical review of budget amendments, study subject data entry and visit information in order to facilitate accurate billing/invoicing.
• Works closely with the clinical research teams to promote the use of the Clinical Research Management System as the primary tool for managing the participant data for clinical trials.
• Ensures timely completion of CTMS information in all tracking systems

Clinical Research Revenue Recovery

• Using the CTMS, generates invoices to external sponsors, working with study team members to proactively analyze and resolve any questions or conflicts.
• Acts as the primary point of contact for external sponsors on all clinical research invoices.
• Maintains clinical research check detail posting from bursar feed to clinical research internal site.
• Performs analysis and reconciliation of assigned accounts receivable information for all relevant UMMS finance departments/divisions.
• Analyzes, assesses and resolves any account balance discrepancies between sponsors and UMMS.
• Reviews, verifies, and processes all submitted clinical research account closure requests.

Clinical Research Billing

• Monitors relevant compliance program components (such as Medicare cost coverage analysis, billing grids, study calendars and budgets.)
• Provides input into departmental efforts focused on identification, analysis, interpretation, implementation and maintenance of relevant federal and state regulations and local policies.
• Conducts daily central monitoring of EPIC clinical research billing review que.
• Actively works with clinical partners, providing regular information necessary to facilitate UMMS/UMMHC clinical research.

Education & Reporting

• Manages assigned tasks via the TRACs intake portal, interpreting requests, ensuring timely completion and accurate tracking
• Maintains internal reporting systems, providing metrics to senior management ensuring that metrics are captured in an accurate and timely manner.
• Develops and maintains assigned curriculum, training materials, job aids, SOPs, and policies
• Delivers relevant training and orientation to clinical research staff/faculty.
• Develops and maintains division web pages/web page content.

Clinical Research Operations Analyst

REQUIRED QUALIFICATIONS:

• Bachelor's Degree in a related field, or equivalent experience
• Minimum 1-3 years of experience in a clinical research environment within a healthcare or academic organization.
• Working knowledge and understanding of federal, state regulation and guidance related to clinical research, specifically federal clinical research billing requirements.
• Strong analytical, computer and software skills

Clinical Research Operations Analyst II

REQUIRED QUALIFICATIONS:

• Bachelor's Degree in a related field, or equivalent experience
• Minimum 2 years of experience in a clinical research environment within a healthcare or academic organization.
• Experience working with electronic research tools such as CTMS, eCRF, relational databases, and electronic proposal submissions systems required
• Working knowledge and understanding of federal, state regulation and guidance related to clinical research, specifically federal clinical research billing requirements.
• Strong analytical, computer and software skills.

PREFERRED QUALIFICATIONS:

• OnCore & EPIC experience strongly preferred.
• Experience working with clinical trial invoicing/financials preferred
• Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
• OnCore Financial and Management Certifications preferred.