Clinical Research Operations Analyst Open Rank
3 weeks ago
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.
ResponsibilitiesESSENTIAL 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.
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