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Clinical Research Operations Analyst

2 months ago

Worcester, United States InsideHigherEd Full time
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 Ops Analyst I

 

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.

 

Clinical Research Ops Analyst II:

Duties noted above plus:

 

Clinical Research Management System (CTMS) Operations

  • Conducts analytical quality assurance review and analysis of CTMS initial data and completes OCR sign off within the CTMS for all newly awarded protocols.
  • 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. 

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.                                                                   
Qualifications

REQUIRED QUALIFICATIONS:

 

Clinical Research Ops Analyst I:

  • 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 Ops Analyst II:

Requirements noted above plus:

  • 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

 

PREFERRED QUALIFICATIONS:

 

Clinical Research Ops Analyst I:

  • OnCore & EPIC experience strongly preferred.
  • Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
  • OnCore Financial and Management Certifications preferred.

Clinical Research Ops Analyst II:

Requirements noted above plus:

  • Experience working with clinical trial invoicing/financials preferred
Additional Information

** This is a hybrid work model with the understanding that the Clinical Research Operations Analyst will be available and onsite as required to support the department. ** 

 

PREFERRED QUALIFICATIONS:

  • OnCore & EPIC experience strongly preferred.
  • Certification in clinical research (CIP, SOCRA, ACRP or equivalent)
  • OnCore Financial and Management Certifications preferred.