Collecting information
Organizing data
Dermatology Clinical Trials Center Seeks Accounts Receivable Specialist. The Indiana Clinical Trials Center & Optima Research are recruiting an experienced full time Accounts Receivable Specialist to join our team in Plainfield, IN.. The primary responsibilities of the Clinical Trials Accounts Receivable Specialist include various tasks related to posting, remittance follow-up, study reconciliation, EOM reporting, A/R management, and invoice submissions.. EOM Reporting: After reconciliation of CRIO, monthly payment posting, and bank account generate month reports and submit to Optima accounting team.. ICTC is a successful extension of The Dermatology Center of Indiana (DCI) located in Plainfield, Indiana.
The Clinical Research Nurse, ensures that the health and safety of research participants and the integrity and quality of clinical trials, are maintained and conducted in accordance with federal, state, IRB, departmental, and institutional regulations, policies and procedures.. The Clinical Research Nurse will primarily provide nursing expertise and care to research study patient management with primary focus on bone marrow transplantation and cellular therapy clinical trial protocols.. They will serve as a liaison and work closely with investigators, department members, study sponsors, IRB and the institution, to support administration of compliance, financial, personnel and other related aspects of all ongoing clinical studies.. Minimum 2 years’ experience in Pediatric Bone Marrow Transplant/Hematology-Oncology nursing required. Knowledge of Institutional Review Board (IRB) policies and procedures
The Department of Medicine, Cardiovascular Division at the Miller School of Medicine, University of Miami is seeking a highly motivated and experienced Manager, Clinical Research to lead and oversee the division's clinical research support team.. The Manager, Clinical Research (A) oversees the development of clinical trials and research programs that support the overall mission of the University.. This role is also responsible for the independent execution of regulatory-related decisions/strategies and coordinates work with study managers and other relevant team members to assure the fidelity of study protocols and data collection.. UHealth-University of Miami Health System, South Florida's only university-based health system, provides leading-edge patient care powered by the ground breaking research and medical education at the Miller School of Medicine.. As an academic medical center, we are proud to serve South Florida, Latin America and the Caribbean.
Educates patients and families about clinical trials, potential benefits and goals of clinical research.. Ensures regulatory compliance for each study by following IRB policies and procedures, study requirements, federal regulations, etc.. Entity: UNC REX Healthcare. Organization Unit: Rex Cancer Center Research. This position is employed by NC Health (Rex Healthcare, Inc., d/b/a NC Health), a private, fully-owned subsidiary of UNC Heath Care System.
Provide skilled nursing care, including wound care, medication administration, and IV therapy.. Accurately document patient care using electronic health record (EHR) systems.. Current Registered Nurse (RN) license in the state of practice.. Home Health Nurse certification preferred.. Understanding of Medicare and Medicaid guidelines for home health services
Overview The work of this position is performed at St. Francis Hospital in Hartford, CT. The Clinical Research Nurse II (CRN II) is responsible for providing research services to patients participating in clinical trials within the Yale Cancer Center Clinical Trials Office, while ensuring safe, compliant, efficient, and effective conduct of clinical trials. Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Adheres to study protocol, maintains accurate documentation, recruits study participants, and ensures regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. Reviews Beacon order set with CRC in anticipation of upcoming participant's clinic visit. Required Education and Experience Graduate of an accredited nursing program and minimum three (3) years of related nursing experience in a hospital, clinic, or similar health care setting required or 3 years of clinical research nurse experience, or equivalent combined experience, or the equivalent combination of education or experience.
Collaborates with Cancer Center nursing staff to provide nursing care to patients receiving therapy on a clinical research trial. Coordinate study enrollment, protocol treatment and follow up care for patients participating in clinical trials. Provides patient teaching about research in general, their specific clinical trial and treatment they will be receiving, HIPAA regulations and any other information related to clinical trials. Prepares and submits clinical trial information for IRB submission and presents to IRB with PI. Gives required updates and summary. Maintains NCI RCR investigator registrations and other relative research compliance documentation.
This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing). Advanced understanding of drug development principles and clinical trial implementation and management. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Reporting to the Senior Vice President, Quality and Regulatory Affairs, the Vice President, Quality Assurance is responsible for the formulation, implementation and realization of the Company's global Quality strategy.. The Vice President, Quality Assurance will: work with R&D, Clinical, Medical, Regulatory Affairs and Engineering on the company’s Quality strategy as a key input to product development; maximize on-time product approvals; manage strict regulatory practices globally within global standards of practice; maintain and protect the Company's existing product approvals; and develop and maintain high quality, productive relationships with statutory regulatory bodies globally.. Lead the Quality Management System and Global QA team to ensure maintenance, improvement and development of the QMS in accordance with company values, policies, requirements & objectives. Further post-graduate degree in Regulatory Affairs, e.g. Masters of Regulatory Science or post-graduate commercial degree, e.g. MBA is desirable. Demonstrated experience in obtaining FDA approval for IDE/PMA and IND/NDA/BLA therapies is mandatory
Join to apply for the Principal Regulatory Affairs Specialist role at Analog Devices. Principal Regulatory Affairs Specialist. Analog Devices, Inc. (NASDAQ: ADI ) is a global semiconductor leader that bridges the physical and digital worlds to enable breakthroughs at the Intelligent Edge. ADI combines analog, digital, and software technologies into solutions that help drive advancements in digitized factories, mobility, and digital healthcare, combat climate change, and reliably connect humans and the world.. The Digital Healthcare Group is looking for an energetic, Principal Regulatory Affairs Specialist for the development of novel solutions.. Sign in to set job alerts for “Regulatory Affairs Specialist” roles.
Key areas of focus include vendor management, cross-functional collaboration, and driving the in vivo and in vitro strategy across the pipeline.. Identify and implement preclinical models that reflect patient pathology; develop assays to support in vitro and in vivo assessments of efficacy or relevant biomarker activity.. Lead and oversee in vivo preclinical safety, PK/PD, and potential efficacy studies.. Define preliminary dosage and dosing regimens based on in vitro and in vivo data; partner with CMC and device teams to ensure feasible delivery approaches.. Ph. D. in Pharmacology, Pharmacokinetics, Biology, or related scientific fields.
Overview Everlywell is a digital health company pioneering the next generation of biomarker intelligence—combining AI-powered technology with human insight to deliver personalized, actionable health answers.. We transform complex biomarker data into life-changing insights—seamlessly integrating advanced diagnostics, virtual care, and patient engagement to reshape how and where health happens.. Role and Scope The Director of Regulatory and Quality Assurance provides strategic leadership and oversight of Everly Health’s enterprise Quality Management System (QMS) and regulatory affairs operations.. Minimum 7-10 years of experience in regulatory affairs and/or quality assurance within diagnostics, medical devices, or digital health sectors.. Expertise in FDA regulatory submissions (510(k), Convenience Kit, EUA, etc.)
Organize and track the internal review process of regulatory documents, including reconciliation of review comments, editing, formatting, version control, and finalization within the Veeva RIM Platform. Collaborate with Regulatory Operations to enhance regulatory submission and information management capabilities within the Veeva RIM platform. Support the implementation of the Veeva RIM platform in collaboration with internal and external stakeholders and vendors. Solid understanding of Good Clinical Practice (GCP) and end-to-end regulatory submissions and archival processes. Proficiency in Veeva Regulatory Information Management (RIM) platform required
In this role, the Regional Director, Managed Care Compliance implements effective compliance programs adhering to the Centers for Medicare & Medicaid Services (CMS) requirements for providers to prevent, detect, and correct program noncompliance, as well as fraud, waste, and abuse (FWA). This individual will also coordinate policies and procedures, training and education, delegation oversight activities by business unit owners of first-tier, downstream and related entities (FDRs) that are considered delegated for a Medicare function and auditing. Serves as Managed Care Compliance Officer for Torrance Memorial and Cedars-Sinai Medical Network operations.. Master's degree in healthcare administration, Law, Public Administration, or Business Administration strongly preferred. Work experience in California managed care regulatory affairs and/or Compliance
Our flagshipproduct, SIR-Spheres Y-90 resin microspheres, is a targeted radiation therapy for liver cancer.. Reporting to the Senior Vice President, Quality and Regulatory Affairs, the Vice President, Quality Assurance is responsible for the formulation, implementation and realization of the Company's global Quality strategy.. The Vice President, Quality Assurance will: work with R&D, Clinical, Medical, Regulatory Affairs and Engineering on the company's Quality strategy as a key input to product development; maximize on-time product approvals; manage strict regulatory practices globally within global standards of practice; maintain and protect the Company's existing product approvals; and develop and maintain high quality, productive relationships with statutory regulatory bodies globally.. Further post-graduate degree in Regulatory Affairs, e.g. Masters of Regulatory Science or post-graduate commercial degree, e.g. MBA is desirable. Demonstrated experience in obtaining FDA approval for IDE/PMA and IND/NDA/BLA therapies is mandatory
The Certified Clinical Coder Program Specialist V in this position must be proactive in seeking input from other staff in the Medicaid and CHIP Services Department and demonstrate the ability to work as an effective team member within Medical Benefits as well as other divisions and business areas within HHSC.. (30%) Researches, analyzes, and synthesizes Medicaid medical benefit policy, complicated federal and state regulations, client information, and claims processing information for medical benefit reviews with a focus on clinical/medical coding and billing related projects.. Acts as the liaison with HHSC staff and other business areas and HHS agencies by providing complex technical assistance and guidance on medical benefit coding and billing related changes during workgroups and meetings.. Medical Billing and Coding certificate is required; preferred through the American Health Information Management Association (CCS-P, CCS) or American Association of Professional Coders (COC, CPC).. Review our Tips for Success when applying for jobs at DFPS, DSHS and HHSC.
Medication Access Coordinator - Medical Billing (Reimbursement Specialist). Position Highlights: Nebraska Medicine is now taking applications for a talented individual to join us as an Experienced Medication Access Coordinator in our Retail/Specialty Pharmacy department and will focus on medical billing.. The MAC will support the new home infusion location by completing prior authorizations, insurance appeals, and removing any medication access barriers for patients.. (Also known as: Medical Billing, Reimbursement Specialist, Pharmacy Advocate, Pharmacy Insurance Tech, Pharmacy Technician, Pharmacy Financial Counselor). Leading Health Network Work with the region's top academic health network, partnering with UNMC to transform lives through education, research, and patient care.
Regulatory Affairs Technical Lead (Finance). As a pioneer and market leader in robotic-assisted surgery, we strive to foster an inclusive and diverse team, committed to making a difference.. Having broad regulatory affairs expertise or unique knowledge, uses skills to contribute to development of company objectives and principles and to achieve goals in creative and effective ways.. Must provide a writing sample , e.g., named Correspondent Contact on a cleared 510(k) listed on FDA's website with a posted 510(k) Summary.. Working knowledge of human anatomy and physiology.
Everlywell is a digital health company pioneering the next generation of biomarker intelligencecombining AI-powered technology with human insight to deliver personalized, actionable health answers.. We transform complex biomarker data into life-changing insightsseamlessly integrating advanced diagnostics, virtual care, and patient engagement to reshape how and where health happens.. The Director of Regulatory and Quality Assurance provides strategic leadership and oversight of Everly Healths enterprise Quality Management System (QMS) and regulatory affairs operations.. Minimum 7-10 years of experience in regulatory affairs and/or quality assurance within diagnostics, medical devices, or digital health sectors.. Expertise in FDA regulatory submissions (510(k), Convenience Kit, EUA, etc.)
We are seeking an experienced Business Analyst (BA) with expertise in Medical Billing and Coding, Java-based applications, SaaS platforms, and Agile methodologies.. Understand and document workflows related to medical billing and coding processes.. Ensure compliance with industry standards such as ICD-10, CPT, HCPCS, HIPAA, and Medicare/Medicaid guidelines.. Assist in optimizing revenue cycle management (RCM) through effective process documentation.. Strong knowledge of medical billing & coding (ICD-10, CPT, HCPCS, RCM, HIPAA).