Collecting information
Organizing data
You will report directly to the Executive Director, Administrator, or Senior Patient Care Manager.. At least three years’ experience of direct patient care and two years’ experience in hospice or home-based care setting. Demonstrates knowledge and compliance with accepted hospice principles and practice, including industry standards, regulations, and best practices (i.e., Medicare, Medicaid, JCAHO, ACHC), company policies/procedures, and understanding of terminally ill patients and their families. Ability to apply knowledge of the unique needs of hospice patient and families from various socioeconomic backgrounds to provide appropriate advocacy and oversight. Comprehensive Benefits Package: Health Insurance, 401k Plan, Tuition Reimbursement, PTO
Gentiva Hospice is a member of the Gentiva family – an industry leader in hospice, palliative, home health, and personal home care. We're looking for a RN Patient Care Manager to join our team. You will report directly to the Executive Director, Administrator, or Senior Patient Care Manager. Managing the site in the absence of the Executive Director, Administrator, or Senior/Executive Patient Care Manager. Knowledge of terminally ill patients and their families along with understanding of hospice concept; knowledge of roles of all disciplines providing hospice services; excellent patient assessment skills; good oral and written communication; thorough knowledge of managed care principles, regulatory guidelines (i.e., Medicare, Medicaid, and human resource) management principles.
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
Design and deploy AI/GenAI solutions in areas such as member engagement, care management, utilization management, risk adjustment, and fraud detection. Bachelor's degree in Computer Science, Engineering, Data Science, Healthcare Administration, or related field (Master's or MBA preferred). Strong understanding of the U.S. healthcare payer ecosystem-commercial, Medicare, Medicaid-and associated data systems (claims, EMR, HEDIS, etc.. Experience in responsible AI governance, data privacy (HIPAA), and regulatory compliance. Experience with GenAI tools and platforms (OpenAI, Anthropic, Vertex AI, Bedrock, etc.)
You will be the Regulatory Advisor and function as the "R" in the core Medical, Legal, and Regulatory review functions within the Commercial Material Review Process (CMRP).. You will be product or project business lead for global CMRP at Takeda. CMRP Meeting Chair - pausing to communicate comments to coordinator, diffusing team disputes, serving as a dependable negotiator, keeping team focus on our ultimate stakeholders which are the patients who trust us to do the right thing, and overseeing escalation steps if MLR cannot come to alignment or if there is new data or campaigns that require senior level management input or alignment.. Exercise decision-making authority within the CMRP to ensure compliance, patient safety, and alignment with Takeda's values.. U.S. based employee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s.
Develops and oversees the financial operations of study coordinator service lines for CTRS/ MSOM investigators, encompassing regulatory and study management services for clinical research trials.. Assists with developing initiatives to transform processes within the CTRS to enhance the clinical research enterprise.. Participates in the design and execution of program improvement plans derived from annual evaluations of the clinical coordinator services of the CTRS.. Helps to develop and operationalize clinical research coordinator services in the UHealth system.. Participates in human resources activities for direct reports, including recruiting and selection, hiring and termination, training, development, mentoring, counseling, performance evaluations, and providing recommendations to CTRS leadership.
SMS Clinical Research is currently seeking candidates for a Clinical Research Regulatory Specialist for their office in Mesquite TX. Submits protocols and supporting documents to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.. Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems.. Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA).. Maintains compliance with Good Clinical Practice (GCP) guidelines, ALCOA guidelines, patient confidentiality (HIPAA) and any other applicable laws.
Must hold appropriate credential, including one or more of the following: Certified Clinical Research Professional (CCRP), Certified Clinical Research Associate (CCRA), Masters in Public Health, Masters in Clinical Research, Masters in Clinical Trials, Masters in Research Administration, Master of Healthcare Administration, or similar qualification.. Pursuant to the Jeanne Clery Disclosure of Campus Security Policy and Campus Crime Statistics Act (Clery Act), you may view Portland Community College’s (PCC) most recent Annual Security Report (ASR) on the Department of Public Safety website.. The ASR contains current security and safety-related policy disclosure statements, emergency preparedness and evacuation information, crime prevention and sexual assault prevention information and resources, and drug and alcohol prevention programming.. The ASR also contains crime statistics for Clery Act crimes which occurred on PCC properties for the last three calendar years.. Paper copies of the ASR are available upon request at all Department of Public Safety offices.
As a Clinical Research Monitor, you ensure trial patients' safety by assuring trials are conducted ethically and within regulatory compliance, data accuracy, and protocol adherence.. Field monitoring of studies and data collection for clinical trials, assess all data documentation, reports, records, transcripts, exam results for consistency with case report form, and determine if clinical trial/study subject documentation is within parameters of study hypothesis, as well as to monitor clinical trial/study safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements.. Provide oversight of and insights into trial activities (e.g., trends in protocol compliance, enrollment, monitoring deviations, data quality) to principal investigators and support staff, and study sponsor management and leadership staff, including Institutional Review Boards/Ethics Committees/Research Ethics Boards, Contract, and Training, developing process improvements.. 3 year's relative work experience in the areas of clinical research (as a CRC or CRA) including quality assurance/control and regulatory compliance or field monitoring. Understanding of cardiovascular anatomy, pathology and physiology
Director, Clinical Research, Atherosclerosis page is loaded Director, Clinical Research, Atherosclerosis Apply remote type Hybrid locations USA - New Jersey - Rahway USA - Massachusetts - Boston (MA Parcel B Laboratory) time type Full time posted on Posted 3 Days Ago time left to apply End Date: June 27, 2025 (4 days left to apply) job requisition id R343073. The Director (Principal Scientist) has primary responsibility for the planning and directing clinical research activities involving new or marketed medicines in the Atherosclerosis section of the Atherosclerosis & Metabolism therapeutic area.. Minimum of 1 year of industry experience in drug development or biomedical research experience in academia. Board Certified or Eligible in Cardiology (adult or pediatric), Endocrinology, or Nephrology or related discipline. Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products.
The GRA Device team is a globally diverse team supporting the medical device, combination product, biosurgery, digital health and in-vitro diagnostic products within the Sanofi portfolio of products.. The team is part of the Global Regulatory Affairs, Regulatory CMC and Device Department within Global Research and Development.. Contribute to product development planning, including strategies to bridge drug delivery systems during development. Proven experience in global medical devices regulatory for drug-led combination products and standalone drug delivery devices. Working knowledge with technical/industry standards related to combination products and standalone drug delivery medical devices
We have built a multi-disciplinary organization of scientists, engineers, and physicians and we are using the power of next-generation sequencing (NGS), population-scale clinical studies, and state-of-the-art computer science and data science to overcome one of medicine’s greatest challenges.. The Associate Director of Global Regulatory Affairs & Safety serves as a key point of contact for GRAIL’s UK Responsible Person (UKRP).. Support the legal manufacturer (GRAIL US) in preparation and delivery of required regulatory reports, e.g. annual reports to the MHRA according to regulatory reporting timelines for marketed products in assigned jurisdictions.. Experience in diagnostics or biomarker development with emphasis on oncology is a plus.. In addition, GRAIL offers a progressive benefit package, including flexible time-off, a 401k with a company match, and alongside our medical, dental, vision plans, carefully selected mindfulness offerings.
Working under the direction of the AVP Quality & HRO, the Patient Safety Consultant focuses on the overall management of patient safety program, event reviews and data analysis.. Is responsible for the delivery of High Reliability and patient safety education, utilizing best practice strategies and methods within safety science to improve all aspects of safe patient care delivery, quality of care, and risk mitigation.. Collaborates with the Office of Patient Experience on the review and response to patient complaints involving patient safety issues.. Provides guidance to clinicians on optimizing the use of the patient safety event reporting system.. 5-7 years of clinical healthcare experience, preferably with a focus on patient safety required
Are you a detail-oriented professional with expertise in Medicaid billing for Long Term Care/Skilled Nursing Facilities?. Prepare and Submit Claims : Process Medicaid billing with precision, ensuring compliance with all state and federal regulations.. Experience : Proven track record in Medicaid billing for Long Term Care/Skilled Nursing Facilities is required.. Technical Skills : Proficiency with Medicaid billing software and Microsoft Office Suite.. Apply today to join our team and help us provide exceptional care to our residents while advancing your career in Medicaid billing.
ERA Health Research is a fast-growing clinical research company that is seeking a Clinical Research Nurse Coordinator who will play a critical role in supporting clinical research activities within the clinical site.. The Clinical Research Nurse Coordinator role requires hands-on patient care, meticulous attention to compliance standards, and collaboration with multidisciplinary teams to ensure the success of clinical trials conducted at the site.. Support: Prepare, submit, and manage Institutional Review Board (IRB) correspondence and regulatory documentation, ensuring adherence to clinical site requirements.. Familiarity with Institutional Review Board (IRB) requirements and regulatory processes.. Knowledge of clinical research protocols, Good Clinical Practice (GCP), and regulatory guidelines.
QP2-IO team is part of the Global Clinical Development organization and has oversight over drug development aspects related to clinical pharmacology, mechanistic PK-PD modeling and pharmacometrics of oncology drugs from post-PCC to registration.. Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics (monoclonal antibodies, antibody drug conjugates, T-cell engagers, bispecifics) in Oncology, authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs. Ph. D., with at least seven years of pharmaceutical drug development experience relating to: systems biology, PKPD, pharmacometrics, mathematics, chemical/biomedical engineering or related field.. Antibody Drug Conjugates (ADC), Clinical Pharmacology, Data Modeling, Data Modeling Software, Data Modeling Tools, Data Visualization, Drug Development, Pharmacology Research, Pharmacometrics, Regulatory Documents. C (Programming Language), Clinical Trials, MathWorks SimBiology, MATLAB, Nonlinear Mixed Effects Modeling (NONMEM), NONMEM, Oncology, Pharmaceutical Development, PKPD Modeling, Programming Languages, Regulatory Submissions, R Programming, T Cells
Part-time Assistant Clinical Research Coordinator. The Helen Diller Family Comprehensive Cancer Center (HDFCCC) Clinical Research Support Office (CRSO) has experienced unprecedented growth in the recent years and is seeking a limited appointment Assistant Clinical Research Coordinator for the Pediatric Oncology Program to assist with the daily needs of our clinical trials.. The HDFCCC integrates the work of researchers and clinicians dedicated to four fundamental pursuits: laboratory research into the causes of cancer progression; clinical research to translate new knowledge into viable treatments; compassionate, state-of-the-art patient care; and population research that can lead to improvements in prevention, early detection, and quality-of-life for those living with cancer.. The twin pillars of precision medicine and precision population health guide research and treatment at HDFCCC.. The University of California, San Francisco (UCSF) is a leading university dedicated to promoting health worldwide through advanced biomedical research, graduate-level education in the life sciences and health professions, and excellence in patient care.
As an essential healthcare system, Harris Health champions better health for the entire community, with a focus on low-income uninsured and underinsured patients, through acute and primary care, wellness, disease management and population health services.. Ben Taub Hospital (Level 1 Trauma Center) and Lyndon B. Johnson Hospital (Level 3 Trauma Center) anchor Harris Health’s robust network of 39 clinics, health centers, specialty locations and virtual (telemedicine) technology.. The D PS/RM serves as the liaison between the system and hospital executive team for matters related to the Patient Safety or Risk Management program.. The D PS/RM reports directly to the Vice President of Patient Safety and Risk Management with a dotted line to the pavilion Executive Vice President (EVP).. - Certified Professional Patient Safety (CPPS) (Or) Cert Prof-Healthcare Risk Management (CPHRM) (Or) Cert Prof in Health Care Quality (CPHQ) within 2 years of employment
Working Title: Clinical Research Coordinator. Collaborate with other clinical research team members, investigators, and hospital staff to ensure tests and procedures required by research protocols are performed and documented (e.g., vital signs, phlebotomy, specimen processing, electrocardiograms (EKGs), research drug administration, and protocol-specific tests and procedures); follow up with appropriate persons on missing or discrepant data. ECO Pass: Reduced rate RTD Bus and light rail service. CCRC - Certified Clinical Research Coordinator. CCRA - Certified Clinical Research Associate
We are seeking a Sr. Research Nurse who will provide research coordination support for complex early phase clinical trials conducted in the Drug Development Unit (DDU) in the Division of Clinical Pharmacology.. The Sr. Research Nurse will collaborate with the study's clinical team and faculty to implement multiple research protocols and will oversee study related activities.. Oversees and supports study visits for non-licensed DDU staff (e.g. study coordinator, clinical research fellow).. At the direction of the Clinical Pharmacology faculty, assists in ordering research doses of radioisotopes from a commercial radiopharmacy.. Assist in monitoring the data integrity of studies assigned to other research nurse coordinators using Quality Assurance forms maintained by the DDU.