Role Description The Auditor will have a sound understanding and knowledge of applicable ICH Good Clinical Practice (GCP) guidelines, applicable local and country clinical research regulations for the conduct of clinical research. Will conduct audits that will impact quality across Velocity to include primarily Investigator Site Audits and assisting with other quality initiatives or audits. Will be responsible for building and maintaining effective working relationships with internal customers throughout the company. This role is highly visible in the company. Responsibilities - Plan, execute, report routine or directed GCP audits (e.g., investigator site, vendor, internal process, document) using a risk-based approach or as identified by Velocity Quality Leadership. - Maintain significant knowledge of clinical research regulatory requirements and ICH GCP principles. - Lead and/or assist with audit activities including investigator site audits, key document audits, sponsor audits. - Follow audit activities from plan through audit closure based on experience and a sound understanding of regulatory requirements related to clinical trials, including ICH Good Clinical Practice (GCP) guidance. - Work with internal customers to provide guidance on SOP/regulatory requirements. - Support (or facilitate, as needed) onsite or remotely and report outcomes of sponsor/CRO audits of Velocity sites. - Work within the Quality function to improve quality across Velocity. - Assist in the creation, review, revision, and management of procedural documents. - Identify and escalate issues, complaints, non-conformances, etc. - Evaluate internal compliance with Velocity procedures, policies, programs, initiatives, GCP, and applicable regulations. - Provide support for CAPA process, investigations, nonconformances and inspections and external audits. May be required to lead less complex CAPA investigations as applicable. - Assist with oversight of contract auditor assignments, as assigned. - Other duties as assigned. Qualifications - Excellent interpersonal, communication (verbal and written), and collaboration skills when interacting with senior management, peers, sponsors/CROs and clinical research sites. - Comprehensive knowledge, understanding and experience with GCPs and (inter)national and local regulations and laws related to clinical trials and clinical research. - Work with integrity, have a commitment to quality, be flexible, and have the ability to think critically and be creative. - Recognize and manage confidential information appropriately. - Ability to work independently or as part of a team to plan, organize, prioritize, and follow up on multiple requests, tasks/objectives, and deliverables. - Ability to lead or support sponsor audits and regulatory inspections. - Must be detail-oriented yet able to maintain a “big picture” or overview of the situation, project, business, etc. - Practical ability in applying proactive quality approaches for clinical trials. - Proficient in the use of computers and computer systems including Microsoft Office, e.g., Word, Excel, PowerPoint, Teams; experience with Excel to identify data trends, develop charts/graphs, etc. is preferred. - Ability to work with clinical study or quality electronic systems (e.g., QMS, EDC, electronic source, e-regulatory). - Ability to travel for work related purposes (Up to 20% travel, as needed, for audits, project team meetings, client presentations and other professional meetings/conferences as needed). Requirements - BS/BA in scientific or healthcare-related field from an accredited college or university. - Require a minimum of at least 3 years of experience as a GCP Auditor in clinical QA. - Conducting GCP clinical investigator site audits and vendor audits. - Experience with internal audits is a plus. - Employing risk identification and mitigation strategies related to identified and potential compliance issues, or a combination of education, training, and experience to meet the position requirements and responsibilities. - Certification encouraged but not required (e.g., SQA RQAP-GCP, ASQ Certified Quality Auditor). Company Description

Role Description This position is located in the Health Information Management (HIM) section at the Sioux Falls VA Medical Center. MRTs (Coder) are skilled in classifying medical data from patient health records in the hospital setting, and/or physician-based settings, such as physician offices, group practices, multi-specialty clinics, and specialty centers. - Temporarily eligible for Remote work within 50 miles of a VA Medical Center. - May fall under the Presidential Memorandum titled "Return to In-Person Work" which will require you to go into the office if the exemption is not approved at the next review. - Total Rewards of an Allied Health Professional. Duties may include but are not limited to the following: - Complete and accurate diagnostic and procedural coded data are necessary for research, epidemiology, outcomes and statistical analysis, financial and strategic planning, reimbursement, evaluation of quality of care, and communication to support the patient's treatment. - Diagnoses and procedures will be coded utilizing the current edition of International Classification of Diseases (ICD) Clinical Modification (CM) and Procedure Coding System (PCS), Current Procedural Terminology (CPT), and/or Healthcare Common Procedure Coding System (HCPCS). - Apply comprehensive knowledge of medical terminology, anatomy & physiology, disease processes, treatment modalities, diagnostic tests, medications, procedures as well as the principles and practices of health services and the organizational structure to ensure proper code selection. - Reviews assigned codes from the current version of several coding systems to include current versions of ICD, CPT, and/or HCPCS. - Adheres to accepted coding practices, guidelines and conventions when validating the most appropriate diagnosis, operation, procedure, ancillary, or evaluation and management (E/M) code to ensure ethical, accurate, and complete coding. - Applies guidelines specific to certain diagnoses, procedures, and other criteria used to classify patients under the Veterans Equitable Resource Allocation (VERA) program. - Assist facility staff with documentation requirements to completely and accurately reflect the patient care provided. - Provides technical support in the areas of regulations and policy, coding requirements, resident supervision, reimbursement, workload, accepted nomenclature, and proper sequencing. - Directly consults with the professional staff for clarification of conflicting or ambiguous clinical data. - Reviews, analyzes and reports performance monitors for inpatient, outpatient, VERA and Non-VA Medical Care (purchased care) coding. - Reviews coding and assists coders in improving coding accuracy; provides coding guidance to various levels of staff to promote consistency in practice and compliance with coding rules and regulations. - Facilitates improved overall quality, completeness, and accuracy of coded data. - Ensures the accuracy and completeness of clinical information used for measuring and reporting physician and medical center outcomes. - Provides ongoing education to all members of the patient care team. - As a technical expert in health information coding matters, provides advice and guidance on documentation and coding requirements. - Maintains current knowledge to ensure that coding and documentation meets regulatory guidelines, audit standards, and results in appropriate data capture and reimbursement. - Analyzes audit results and prepares summary feedback for individual coders and/or clinicians, making recommendations for improvement. - Provides coding consultation to coders and/or clinicians related to coding and documentation questions. Work Schedule - Monday-Friday 8:00am to 4:30pm Pay - Competitive salary and regular salary increases Paid Time Off - 37-50 days of annual paid time off per year (13-26 days of annual leave, 13 days of sick leave, 11 paid Federal holidays per year) - Selected applicants may qualify for credit toward annual leave accrual, based on prior work experience or military service experience. Parental Leave - After 12 months of employment, up to 12 weeks of paid parental leave in connection with the birth, adoption, or foster care placement of a child. Child Care Subsidy - After 60 days of employment, full-time employees with a total family income below $144,000 may be eligible for a childcare subsidy up to 25% of total eligible childcare costs for eligible children up to the monthly maximum of $416.66. Retirement - Traditional federal pension (5 years vesting) and federal 401K with up to 5% in contributions by VA. Insurance - Federal health/vision/dental/term life/long-term care (many federal insurance programs can be carried into retirement). Education Requirements Only education or degrees recognized by the U.S. Department of Education from accredited colleges, universities, schools, or institutions may be used to qualify for Federal employment. Qualifications - One year of creditable experience that indicates knowledge of medical terminology, anatomy, physiology, pathophysiology, medical coding, and the structure and format of health records; OR - An associate's degree from an accredited college or university recognized by the U.S. Department of Education with a major field of study in health information technology/health information management, or a related degree with a minimum of 12 semester hours in health information technology/health information management. - Completion of an AHIMA approved coding program, or other intense coding training program of approximately one year or more that included courses in anatomy and physiology, medical terminology, basic ICD diagnostic/procedural, and basic CPT coding. - Equivalent combinations of creditable experience and education are qualifying for meeting the basic requirements. Certification - Must have either Apprentice/Associate Level Certification through AHIMA or AAPC. - Mastery Level Certification through AHIMA or AAPC. - Clinical Documentation Improvement Certification through AHIMA or ACDIS. Physical Requirements See VA Directive and Handbook 5019, Employee Occupational Health Service. English Language Proficiency MRTs (Coder) must be proficient in spoken and written English as required by 38 U.S.C. § 7403(f). Grade Determinations - Medical Records Technician (Coder) Auditor, GS-9. - One year of creditable experience equivalent to the journey grade level of a MRT (Coder) (GS-8). - Employees at this level must have a mastery level certification.

Role Description Position responsible for ensuring the accuracy and completeness of clinical coding resulting in the appropriate reimbursement and data integrity and validation of the coded information for external and internal affairs. This position typically reports to the Coding Compliance Manager. Qualifications - High school diploma or GED, required - Inpatient: - Registered Health Information Technician (RHIT) - Registered Health Information Administrator (RHIA) - Certified Coding Associate (CCA) - Certified Coding Specialist (CCS) - Certified Inpatient Coder (CIC) - Outpatient: - Registered Health Information Technician (RHIT) - Registered Health Information Administrator (RHIA) - Four (4) years of relevant hospital coding or auditing experience required - Experience coding/auditing in a level 1 trauma facility/academic teaching facility strongly preferred - Extensive knowledge of ICD-10-CM and CPT coding principles and guidelines - Extensive knowledge of 3M Coding applications and resolving coding edits - Working knowledge of reimbursement systems and regulations and policies pertaining to documentation, coding, and billing - Knowledge of database applications and spreadsheet design - Effective oral and written communication skills Requirements - Conducts regular coding audits and coordinates ongoing monitoring of coding accuracy, providing continuous feedback to coding staff - Develops and coordinates educational sessions to all coding staff regarding documentation and accurate coding - Serves as a resource for coding staff on organization-wide coding and documentation standards and guidelines - Designs audit tools to monitor the accuracy of clinical coding - Keeps abreast of coding guidelines and reimbursement reporting requirements - Conducts trend analyses to identify patterns and variations in coding practices - Abides by the Standards of Ethical Coding as set forth by the American Health Information Management Association (AHIMA) and adheres to official coding guidelines - Ensures safe care to patients, staff and visitors; adheres to all Memorial Hermann policies, procedures, and standards within budgetary specifications including time management, supply management, productivity and quality of service - Promotes individual professional growth and development by meeting requirements for mandatory/continuing education and skills competency; supports department-based goals which contribute to the success of the organization; serves as preceptor, mentor and resource to less experienced staff - Demonstrates commitment to caring for every member of our community by creating compassionate and personalized experiences - Models Memorial Hermann’s service standards by providing safe, caring, personalized and efficient experiences to patients and colleagues - Other duties as assigned Company Description At Memorial Hermann, we pursue a common goal of delivering high quality, efficient care while creating exceptional experiences for every member of our community. We know that when our employees feel cared for, heard and valued, they are inspired to create moments that exceed expectations, while prioritizing safety, compassion, personalization and efficiency.

Role Description The Senior Technology Auditor will play a crucial role in conducting audits that impact business operations, processes, and systems, contributing to meeting client needs and maintaining high compliance standards. With an in-depth understanding and knowledge of GxP compliance, regulations, Parexel procedures, and processes, the Senior Technology Auditor will independently plan, conduct, and manage internal and external audits while mentoring less experienced auditors. They may also act as QA leads for audit programs or clients. Collaborating with QA Management, they will actively contribute to process improvement, streamline processes, identify opportunities, provide consultancy on critical regulatory compliance, and ensure global and regional audit programs are performed effectively, promoting both process improvement and regulatory compliance. Key Accountabilities - Independently lead, plan, schedule, perform, and report a range of technology audits across all phases of Clinical Research. - Perform and deliver high quality audits/audit reports within specified timelines/budgets, independently or with limited oversight. - Review and identify improvements that enhance the quality and clarity of audit reports. - Travel internationally for audits, as required. - Collect and review responses to audit findings and follow-up/escalate inadequate or delayed responses as necessary. - Act as point of consultancy for Operations and Quality regarding the implementation of adequate CAPAs. - Coordinate internal global process/system audits across regions and develop necessary tools such as report templates, checklists, and standard emails. - Ensure required audits are performed and reported in accordance with Parexel QA requirements, and on time. - Review audit reports, responses, and other program deliverables to ensure consistent high quality. - Maintain required QA tools and ensure Parexel and QA systems are regularly updated with accurate information. - Support the training and mentoring of new/less experienced auditors by performing co-audits, delivering training, and sharing knowledge and experience. Qualifications - Ability to rapidly learn, understand and apply applicable Parexel and client procedures. - Ability to work flexibly, and across multicultural environments. - Ability to learn and use Parexel and client computer systems. - Willingness to work effectively with multiple supervisors in a matrix environment and to value the importance of teamwork. - Excellent interpersonal, verbal, and written communication skills, including the ability to present at conferences, meetings, and training sessions. - Excellent organizational, analytical, problem solving, decision making, and negotiation skills. - Effective at analyzing problems considering the ‘big picture’ and recommending appropriate corrective actions. - Accurate and detail oriented, a critical thinker. - Excellent time management skills with the ability to prioritize workload and manage multiple and varied tasks/projects with enthusiasm. - Ability to diplomatically address sensitive issues confidentially and professionally. Requirements - At least 5 years’ experience in regulatory affairs, clinical research, monitoring, data management, safety/pharmacovigilance, pharmacy, laboratory, or other relevant area in life science. - Minimum of 2 years' experience in quality assurance, auditing, including sound experience of applicable GxP technology auditing. - Excellent knowledge, understanding, and experience of Good Practices (GxPs) and international, national, and local regulations and laws related to clinical trials and other clinical research. Education - Educated to degree level (technology, biological science, pharmacy or other health-related discipline preferred) or equivalent qualification or clinical research experience. - Master’s degree in a science, technology or industry-related discipline preferred.