Sr. Clinical Research Coverage Analyst

Minimum Education
Bachelor's Degree Healthcare, scientific, or related field (Required) And
BSN Preferred BSN, RN, LPN or MD (Preferred)

Minimum Work Experience
8 years experience in research administration (Required)

Required Skills/Knowledge
Expert knowledge of Medicare Clinical Trial Policy (NCD 310.1), National and Local Coverage Determinations (NCDs LCDs), Code of Federal Regulations (CFRs), state laws, and professional practice guidelines.
Knowledge of regulations regarding human subjects in clinical research, outcomes research, nursing research, and other research areas.
Proficient working knowledge of Microsoft Office Suite including Excel and multiple IT systems.
Experience with OnCore Clinical Trials Management System (CTMS) is required.
Effective verbal, written and interpersonal communication skills.
Ability to organize/prioritize time and work independently.
Ability to apply generalized information to specific situations.
Knowledge of drug/device development process and the pharmaceutical and/or medical device manufacturing industry.

Functional Accountabilities
Responsibilities

• Develops Coverage Analysis (CA) on CMS policy and National and Local Coverage Determinations. Review clinical research protocols, informed consent forms, sponsor agreements and and determines which procedures are routine, and therefore, billable to Medicare and other third party payers.

• Code each procedure per the applicable CPT coding guidelines. Identify appropriate research modifiers to be places on claims

• Documents CA determinations to to support the decision-making process. This documentation may be subject to inspection by CMS and regulatory agencies.

• Determines whether a study is a qualifying clinical trial under CMS Clinical Trial Policy.

• Builds calendars and coverage analysis in OnCore

• Participates in the development of clinical research budgets as needed, assisting to provide justification for costs, etc. working collaboratively with Business Office staff.

• Review to the protocol for language that will impact the coverage analysis revise appropriately.

• Maintain a current knowledge of laws and regulations governing professional fee billing, Medicare' Clinical Trial Policy and newly issued guidance. Develops and provides training on these topics for for investigators and CNH research and administrative staff.

• Assist with the development of policies and procedures pertaining to clinical research billing compliance, including the CA process.

• Performs regular research billing reviews to identify billing compliance and develop and implement corrective actions.

• Other duties as required.
• Anticipate and responds to customer needs; follows up until needs are met

Teamwork/Communication

• Demonstrate collaborative and respectful behavior

• Partner with all team members to achieve goals

• Receptive to others' ideas and opinions

Performance Improvement/Problem-solving

• Contribute to a positive work environment

• Demonstrate flexibility and willingness to change

• Identify opportunities to improve clinical and administrative processes

• Make appropriate decisions, using sound judgment

Cost Management/Financial Responsibility

• Use resources efficiently

• Search for less costly ways of doing things

Safety

• Speak up when team members appear to exhibit unsafe behavior or performance

• Continuously validate and verify information needed for decision making or documentation

• Stop in the face of uncertainty and takes time to resolve the situation

• Demonstrate accurate, clear and timely verbal and written communication

• Actively promote safety for patients, families, visitors and co-workers

• Attend carefully to important details - practicing Stop, Think, Act and Review in order to self-check behavior and performance