Clinical Research Operations Analyst

Overview

POSITION SUMMARY:

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

Responsibilities

• 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.
• Analyzes study calendar revisions within the CTMS that impact invoicing and revenue recovery.
• Provides regular review and analysis of CTMS data to ensure complete and accurate capture of relevant information.
• Completes appropriate, detailed, analytical review of budget amendments, study subject data entry and visit information in order to facilitate accurate billing/invoicing.
• 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.
• 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.

Qualifications

• 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.
• Additional Information

PREFERRED QUALIFICATIONS:

• OnCore & EPIC experience strongly preferred.
• Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
• OnCore Financial and Management Certifications preferred.
• This is a hybrid work model with the understanding that the Analyst will be available and onsite as required to support the department**

Responsibilities

• 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.
• Analyzes study calendar revisions within the CTMS that impact invoicing and revenue recovery.
• Provides regular review and analysis of CTMS data to ensure complete and accurate capture of relevant information.
• Completes appropriate, detailed, analytical review of budget amendments, study subject data entry and visit information in order to facilitate accurate billing/invoicing.
• 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.
• 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.

Qualifications

• 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.