Univ) Worker Type Employee Worker Sub-Type Classified Cost Center

CC002113

Office of Clinical Research (OCR) Pay Rate Type Salary Pay Grade University-GEN09 Pay Range 52,100.00

70,300.00
88,600.

000 Scheduled Weekly Hours 40 Work Shift Job Description This is a central research administration position, reporting to the Sponsor Invoicing Program Manager in the Office for Clinical Research (OCR) under the Office for the Vice President for Research (OVPR). This position is responsible for supporting the Office of Clinical Research Industry Sponsor Invoicing, billing, and reconciliation program. In collaboration with department/division Grants Administrators, Principal Investigators and study teams, Research Administration and Grants and Contracts Accounting Offices, this position will coordinate industry sponsored study invoicing, billing and reconciliation activities to ensure that all earned revenue is realized under this OCR fee for service program and provide training, mentorship and guidance for sponsor invoicing within MUSC's Clinical Trial Management System. Services will include supporting post-award industry sponsored research activity tracking, invoicing, billing reconciliation, reporting, and communication processes within SPARCRequest and the OnCore Clinical Trials Management System (CTMS).

Job Responsibilities:

30%

Analyze fully executed clinical trial agreements (CTAs) and translate contract payment terms into study team tracking system templates that support sponsor invoicing for corporate clinical research studies.

Educate study teams on effective study activity tracking to support sponsor invoicing and maximizing clinical research revenue. Provide guidance, training and mentorship in utilization of OnCore CTMS subject and protocol tracking and invoicing: 1. Interpret industry sponsored clinical research contracts and budgets and develop study activity tracking documentation to support appropriate recovery and reimbursement for all study activities. Verify the research record to include protocol and study personnel information, type and source of funding, add the appropriate study costs and build study invoicing calendar within the Clinical Trials Management System to support efficient study tracking and optimization of corporate clinical research revenue and reporting. Work collaboratively and develop effective working relationships with Investigators, key study personnel, departmental finance teams to and Research Administration to accomplish activity tracking and sponsor invoicing goals. 3. Educate study teams on effective study activity tracking on a pre-defined schedule and provide guidance, training and mentorship in utilization of CTMS subject and protocol tracking and invoicing. 4. Effectively prioritize tasks, and follow-up to ensure completion of sponsor invoicing activities in a compliant and timely manner and in accordance to the contract terms. Participate in CTMS planning, testing and development to optimized activity tracking and sponsor invoicing and reconciliation. 30%

Supports the

MUSC OCR

industry sponsor invoicing program for clinical research; provides and supports Sponsor Invoicing, billing reconciliation, communication and reporting to ensure that earned revenue is realized to support the activities of industry sponsored research: 1. Monitor study startup, invoiceable, milestone, per patient visit and administrative (PRA, OCR Finance, IRB, and CTMS fees) activity to ensure proper and full financial reimbursement for these activities. 2. Develop sponsor invoices based on invoicing milestones, invoiceable, and pass through costs ensuring that receipt of revenue is timely and first revenue received is within OCR established reporting goals. 3. Invoice sponsors and/or verify receipt of earned revenue and follow-up with sponsors for unpaid invoices. 4. Apply sponsor payments received in alignment with the Clinical Trial Agreement (CTA) to the appropriate MUSC research account and within CTMS, reviewing CTMS data, and MUSC clinical research financial data systems for accuracy/reconciliation. Ensure receipt of all revenue and financial reconciliation prior to contract/account close out. 5. Work collaboratively and professionally with OCR staff, the Medical University of South Carolina research community, and external research customers such as pharmaceutical companies and Contract Research Organizations (CRO). 6. Work with the department/division business managers and study teams to resolve invoicing issues, communicate with sponsors and Contract Research Organizations (CROs) to resolve disputes and recover earned revenue. 7. Provide superior customer service to effectively meet the needs of internal and external customers. 8. Ensure that invoicing processes are consistent with federal and state regulations and MUSC policies and practices. 20%•

Sponsor Invoicing Analysis and Reporting:

1. Utilize and integrate data from MUSC financial systems, CTMS, Cayuse, eIRB, Epic, SPARCRequest within the Research Integrated Network of Systems (RINS) to monitor impact of sponsor invoicing. 2. Generate and provide monthly industry study financial reports to department for Principal Investigators, Department Administrators, and Business Managers for the studies managed by the OCR Sponsor Invoicing team and provide guidance on interpretation of study financial data. 3. Routinely assist in the preparation of monthly, quarterly, and executive summary reports distributed to principal investigators, department administrators and OCR management and leadership. 4. Provide input on the development of industry study financial reports to support the invoicing process; track, analyze and validate data. 10%

Document and/or manage financial documentation for industry sponsored studies submitted for OCR budgeting and/or sponsor invoicing support.

Implement strategies to ensure that complete and accurate information is captured for managing team workflow and for reporting. Effectively apply problem solving, negotiation, and continuous quality improvement methods in daily operations to improve the invoicing and CTMS processes. 5%

Support the monthly invoicing process for the Office of Clinical Research program services fees. 5%
Participate in cross-functional, multi-disciplinary OCR work teams based upon institutional and departmental priorities and performs other pre
and post-award, as needed.

Minimum Experience and Training Requirements:

Bachelor's degree and 2 years of relevant program experience. Strong project management and organizational skills required. Proficient working knowledge of Microsoft office required. Employee must have the ability to prioritize and complete required tasks with minimal supervision, interpret and apply regulations and policies, and use resources effectively to complete job tasks. Knowledge of grants administration processes, industry sponsored research invoicing, and the clinical research life cycle required.

Preferred Qualifications :

A degree in business administration, public administration or the social sciences and 2-5 years experience in contracts and grant administration activities. Experience as a clinical research coordinator, research nurse coordinator, research/sponsored programs accountant, grants administrator, or professional accountant/financial analyst with direct industry sponsored research experience preferred, or an equivalent combination of experience, education and training. Certification as clinical research professional or equivalent preferred. Knowledge of SPARCRequest, Epic, eIRB, proposal pricing, SmartStream, Darkwing, and research billing highly desirable.

Physical Requirements:

(

Note:

The following descriptions are applicable to this section: Continuous

6-8 hours per shift; Frequent
2-6 hours per shift; Infrequent
0-2 hours per shift) Ability to perform job functions in an upright position.

Additional Job Description Minimum Requirements:

A bachelor's degree and two years relevant program experience.

Physical Requirements:

(

Note:

The following descriptions are applicable to this section: Continuous

6-8 hours per shift; Frequent
2-6 hours per shift; Infrequent
0-2 hours per shift) Ability to perform job functions in an upright position.

(Frequent) Ability to perform job functions in a seated position. (Frequent) Ability to perform job functions while walking/mobile. (Frequent) Ability to work indoors. (Continuous) Ability to work outdoors in all weather and temperature extremes. (Infrequent) Ability to work in confined/cramped spaces. (Infrequent) Ability to perform job functions from kneeling positions. (Infrequent) Ability to squat and perform job functions. (Infrequent) Ability to perform 'pinching' operations. (Infrequent) Ability to fully use both hands/arms. (Frequent) Ability to perform repetitive motions with hands/wrists/elbows and shoulders. (Frequent) Ability to reach in all directions. (Frequent) Possess good finger dexterity. (Continuous) Ability to maintain tactile sensory functions. (Continuous) Ability to lift and carry 15 lbs., unassisted. (Infrequent) Ability to lower objects, up to 15 lbs., from height of 36 inches to floor level, unassisted. 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UNIV - Clinical Research Sponsor Invoicing Analyst - Office of Clinical Research, OVPR