Title : Clinical Research Associate Location: Madison United States Job Description: Piper Companies is actively seeking Clinical Research Associates to join a highly accredited CRO. This position is fully remote but does require travel 60-80% of the time regionally with the Midwest region. The Clinical Research Associate will take part in a very essential role in assisting the process of creating lifesaving drugs and treatments. Responsibilities of the Clinical Research Associate: - Oversee the development and execution of the clinical trial plans and protocols for Phase I-IV - Maintain documentation and data evaluations - Work collaboratively with the team to ensure monitoring activities meet study requirements - Conduct on site field evaluations Qualifications of the Clinical Research Associate: - Experience with Oncology as a therapeutic indication - 3+ years of clinical monitoring experience, specifically with Oncology - Experience with the FDA or similar Regulatory and Accrediting administrations - Bachelor's degree in one of the life sciences or related background Compensation for the Clinical Research Associate: - Salary Range: $120,000-$135,000 - Comprehensive Benefits: Medical, Dental, Vision, 401k, and sick leave if required by law Keywords: Clinical Research Associate, CRA, BA, life sciences, clinical trials, phases, documentation, data, monitor, study, onsite, FDA, drugs, treatments, medical, dental, vision, 401k #LI-KI1 #LI-HYBRID

Role Description The Clinical Documentation Integrity DRG Downgrade Specialist is responsible for reviewing, analyzing, and responding to payer‑initiated DRG downgrades. The role ensures accurate DRG assignment, protects revenue integrity, and supports compliant documentation practices through detailed review, appeal preparation, and performance tracking. The specialist serves as an effective change agent, acting as a resource and educator for providers and interdisciplinary care teams to improve documentation quality, coding accuracy, and audit readiness. Duties & Responsibilities - Analyze payer DRG downgrade notifications to determine validity based on ICD‑10‑CM/PCS coding guidelines, clinical indicators, and documentation sufficiency. - Conduct comprehensive medical record reviews to validate principal diagnosis, secondary diagnoses, procedures, MCC/CC capture, and DRG assignment accuracy. - Write clear, persuasive, evidence‑based appeal letters that incorporate clinical rationale, coding guidelines, and regulatory references to support the original DRG. - Submit appeals within required timelines and track each case through all stages of the appeal lifecycle, including initial review, reconsideration, and final determination. - Maintain detailed logs of downgrade cases, outcomes, appeal success rates, and turnaround times to support throughput monitoring, trend analysis, and performance reporting. - Identify patterns in payer downgrades and escalate systemic issues or documentation vulnerabilities to leadership. - Collaborate with internal teams and providers to clarify ambiguous documentation and ensure clinical specificity. - Identify documentation gaps or inconsistencies and provide targeted feedback to improve provider documentation practices. - Participate in internal audits, retrospective reviews, and quality assurance processes related to DRG validation, coding accuracy, and documentation completeness. - Assist in developing or refining documentation templates, provider education materials, and query processes to support ongoing CDI improvement. - Ensure all coding and documentation practices align with CMS regulations, AHA Coding Clinic guidance, and organizational compliance policies. - Stay current on payer audit trends, regulatory updates, DRG methodology changes, and emerging risk areas that may impact DRG assignment or audit outcomes. - Support compliance initiatives by identifying potential vulnerabilities and recommending corrective actions or process improvements. - Partner with internal teams to resolve complex DRG issues and ensure alignment across departments. - Participate in provider education sessions, meetings, and case reviews to promote accurate documentation and DRG integrity. - Communicate effectively with leadership regarding trends, risks, and opportunities for improvement in documentation and coding practices. - Serve as a subject‑matter expert for DRG downgrade processes, providing guidance and support to internal teams. - Other duties as assigned. - Use, protect and disclose patients’ protected health information (PHI) only in accordance with Health Insurance Portability and Accountability Act (HIPAA) standards. - Understand and comply with Information Security and HIPAA policies and procedures at all times. - Limit viewing of PHI to the absolute minimum as necessary to perform assigned duties. Qualifications - Bachelor’s degree in Nursing required. - Minimum of 3 years of experience in an inpatient clinical documentation improvement role. - Minimum of 5 years nursing experience in adult acute care in medical/surgical, critical care, emergency, and/or PACU setting. - RN license required. - CCDS and/or CDIP required. - CCS or CIC certification required. - Demonstrated inpatient coding experience in an acute care setting. - Prior experience managing DRG downgrades, including appeal letter development. - Deep knowledge of ICD-10-CM/PCS, ICD-10 Official Coding Guidelines and both MS and APR DRG Reimbursement Systems. - Ability to interpret complex clinical documentation across multiple specialties. - Proficiency with EMR systems, encoder tools (e.g., 3M, Optum) and CDI workflow and reporting tools. - Proficiency in Microsoft Office Suite. - Strong interpersonal skills, ability to communicate well at all levels of the organization. - Strong problem solving and creative skills and the ability to exercise sound judgment and make decisions based on accurate and timely analyses. - High level of integrity and dependability with a strong sense of urgency and results oriented. - Excellent written and verbal communication skills required. Working Conditions - Ability to work outside of normal business hours as needed. - Must possess a smart-phone or electronic device capable of downloading applications, for multifactor authentication and security purposes. Physical Demands - While performing the duties of this job, the employee is occasionally required to move around the work area; sit; perform manual tasks; operate tools and other office equipment such as computer, computer peripherals and telephones; extend arms; kneel; talk and hear. Mental Demands - The employee must be able to follow directions, collaborate with others, and handle stress. Work Environment - The noise level in the work environment is usually minimal. Med-Metrix will not discriminate against any employee or applicant for employment because of race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), political affiliation, military service, veteran status, other non-merit based factors, or any other characteristic protected by federal, state or local law.

• Work closely with cross functional teams, vendors, sites and CROs to ensure compliance with global clinical trials for the 360 AF catheter ablation system. • Responsible for completion of all study deliverables, ensuring the highest level of data quality and compliance to quality standards and regulatory guidance. • Proactively identify, communicate and resolve clinical study operational issues. • Participate in process improvement initiatives. • Lead feasibility assessments, site selection, and activation for cardiology centers capable of handling complex AF trial requirements. • Proactively create and execute patient recruitment strategies and risk mitigation plans to meet study milestones. • Supervise Contract Research Organizations (CROs), core labs (e.g., ECG/Holter monitoring), and external vendors to ensure deliverables are met on time and within scope. • Assist in regulatory submissions to (CA, IRB/ECs) according to local requirements or e-submission through the Common European Submission Portal (CESP) in coordination with or without CRO. • Proactively track and manage project tasks against timelines by creating a Smartsheet or timely minutes to alert management when there are risks of having major deviations. • Draft and coordinate review of relevant documents including informed consents, source documents for data entry, power-point slide deck for site initiation visit, monitoring plans, clinical study and/or safety reports and study materials (e.g., newsletters, recruitment posters, study logs, etc.). • May assist in the preparation of documents required by Clinical Study Readiness. • May perform review and Quality Control (QC) study documents filed in the study Trial Master File (eTMF) and Investigator Site File (eISF) as needed. • Oversee device tracking/accountability and reconciliation procedures at participating centers. • May conduct and/or attend SQVs, SIVs, IMVs and COVs and conduct site-level training, as needed. • Advise on site data collection and attend 360 AF catheter ablation clinical procedures as needed. • May perform User Acceptance Testing (UAT) in database for initial and ongoing eCRF development and contribute to the review of EDC guidelines. • Oversee the clinical aspects of timely data cleaning and data analysis by regular review of data metrics and listings. • Ensure that device or procedure related adverse events are identified and appropriate responses to such concerns are developed and executed as outlined in Safety Plan and/or Study Protocol. • Must have general functional expertise to support SOP development and implementation. • Evaluate vendor invoices for completeness and accuracy. • Hire, manage and develop internal team and contractors, as needed. Set objectives, performance goals and empower them to deliver on the Company’s strategic priorities.

Role Description As a Clinical Research Physician at ICON, you will lead clinical trials, ensuring that they are conducted ethically and in compliance with regulatory standards. Your role will involve delivering clinical research work to a high standard, working closely with your team and stakeholders. Key responsibilities include: - Leading the design and execution of clinical trial protocols, ensuring alignment with scientific and regulatory guidelines. - Monitoring patient safety and overseeing the clinical aspects of trials to ensure compliance with GCP standards. - Collaborating with cross-functional teams to analyze study data and provide medical insights that guide decision-making. - Engaging with investigators and study sites to ensure adherence to protocols and facilitate successful trial execution. - Contributing to the preparation of regulatory submissions and clinical study reports. Qualifications - Medical degree (REQUIRED) with relevant clinical research experience. - Strong understanding of clinical trial processes and regulatory requirements. - Excellent clinical assessment skills and a commitment to patient safety and ethical research practices. - Effective communication and interpersonal skills, with the ability to engage with diverse stakeholders. - Demonstrated ability to work collaboratively in a fast-paced, team-oriented environment. - Willingness to go to sites as required (approximately 20%). Requirements - Employment with ICON is contingent upon having the legal right to work in the country where the role is based. Benefits - Competitive base salary and performance related incentives. - Health and wellbeing programmes including medical, dental, and vision coverage where applicable. - Retirement and pension plans. - Life assurance and disability coverage. - Employee assistance programmes and wellbeing resources. - Learning and development opportunities through structured training and career pathways. - Benefits may vary depending on role and location. Inclusion and Accessibility ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.