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Clinical Research Operations Analyst - Open Rank

Clinical Research Operations Analyst - Open Rank

UMass Med SchoolWorcester, Massachusetts, United States
10 days ago
Job type
  • Full-time
Job description

Clinical Research Operations Analyst - Open Rank

Minimum Salary

US-MA-Worcester

Job Location

1 week ago(9 / 23 / 2025 12 : 33 PM)

Requisition Number

2025-48698

# of Openings

Posted Date

Day

Shift

Exempt

Exempt / Non-Exempt Status

Non Union Position -W60- Non Unit Professional

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

    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 Analystwill be available and onsite as required to support the department
  • #LI-KR1

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    Open Rank • Worcester, Massachusetts, United States

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