Children's National Medical Center
Sr. Clinical Research Coverage Analyst
Children's National Medical Center, Silver Spring, Maryland, United States, 20900
Job Description – Sr. Clinical Research Coverage Analyst (250003DG)
Job Description
Sr. Clinical Research Coverage Analyst - (250003DG)
Description The Sr. Clinical Research Coverage Analyst is responsible for reviewing clinical research protocols, Informed Consent Forms, and other relevant study-related documents. The Coverage Analyst determines whether proposed clinical research studies are a qualifying clinical trial as defined by the Medicare Clinical Trial Policy (NCD 310.1), while also being cognizant of Medicare/Medicaid Benefit Policies, third‑party Medical Benefit Policies, relevant National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs), Code of Federal Regulations (CFRs), state laws, professional practice guidelines, claims denial reports from the Institution and, when necessary, consult with the Medicare Administrative Contractor (MAC) for the region. Provides skilled clinical trial review and analysis for a variety of department financial processes, including billing compliance and to ensure proper cost coverage for the Informed Consent. Impacts operational procedures and practices in the department. Performs special assignments as required and prepares detailed audit reports, cost reports, etc., for departmental and institutional use.
Qualifications
Minimum Education:
Bachelor's Degree in 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 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 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's Clinical Trial Policy and newly issued guidance. Develops and provides training on these topics 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.
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.
Primary Location Maryland‑Silver Spring
Work Locations Inventa Towers 1 Inventa Place Silver Spring 20910
Job Non‑Clinical Professional
Organization Office Grants Contrcts Finance
Position Status : R (Regular) – FT – Full‑Time
Shift : Day
Work Schedule : Mon‑Fri
Job Posting Jan 7, 2026, 2:57:26 PM
Full‑Time Salary Range 93329.6 – 155563.2
Children’s National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law. The “Know Your Rights” poster is available here: and the pay transparency policy is available here: Know Your Rights Pay Transparency Nondiscrimination Poster.
Please note that it is the policy of Children's National Hospital to ensure a “drug‑free” work environment: a workplace free from the illegal use, possession or distribution of controlled substances (as defined in the Controlled Substances Act), or the misuse of legal substances, by all staff (management, employees and contractors). Though recreational and medical marijuana are now legal in the District of Columbia, Children’s National and its affiliates maintain the right, in accordance with our policy, to enforce a drug‑free workplace, including prohibiting recreational or prescribed marijuana.
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Sr. Clinical Research Coverage Analyst - (250003DG)
Description The Sr. Clinical Research Coverage Analyst is responsible for reviewing clinical research protocols, Informed Consent Forms, and other relevant study-related documents. The Coverage Analyst determines whether proposed clinical research studies are a qualifying clinical trial as defined by the Medicare Clinical Trial Policy (NCD 310.1), while also being cognizant of Medicare/Medicaid Benefit Policies, third‑party Medical Benefit Policies, relevant National Coverage Determinations (NCDs) and Local Coverage Determinations (LCDs), Code of Federal Regulations (CFRs), state laws, professional practice guidelines, claims denial reports from the Institution and, when necessary, consult with the Medicare Administrative Contractor (MAC) for the region. Provides skilled clinical trial review and analysis for a variety of department financial processes, including billing compliance and to ensure proper cost coverage for the Informed Consent. Impacts operational procedures and practices in the department. Performs special assignments as required and prepares detailed audit reports, cost reports, etc., for departmental and institutional use.
Qualifications
Minimum Education:
Bachelor's Degree in 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 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 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's Clinical Trial Policy and newly issued guidance. Develops and provides training on these topics 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.
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.
Primary Location Maryland‑Silver Spring
Work Locations Inventa Towers 1 Inventa Place Silver Spring 20910
Job Non‑Clinical Professional
Organization Office Grants Contrcts Finance
Position Status : R (Regular) – FT – Full‑Time
Shift : Day
Work Schedule : Mon‑Fri
Job Posting Jan 7, 2026, 2:57:26 PM
Full‑Time Salary Range 93329.6 – 155563.2
Children’s National Hospital is an equal opportunity employer that evaluates qualified applicants without regard to race, color, national origin, religion, sex, age, marital status, disability, veteran status, sexual orientation, gender, identity, or other characteristics protected by law. The “Know Your Rights” poster is available here: and the pay transparency policy is available here: Know Your Rights Pay Transparency Nondiscrimination Poster.
Please note that it is the policy of Children's National Hospital to ensure a “drug‑free” work environment: a workplace free from the illegal use, possession or distribution of controlled substances (as defined in the Controlled Substances Act), or the misuse of legal substances, by all staff (management, employees and contractors). Though recreational and medical marijuana are now legal in the District of Columbia, Children’s National and its affiliates maintain the right, in accordance with our policy, to enforce a drug‑free workplace, including prohibiting recreational or prescribed marijuana.
#J-18808-Ljbffr