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The Nurse Director of Quality Assurance will have a unique opportunity to make significant impacts on the quality of care and patient safety at an amazing hospital in the heart of Illinois.. The RN Director of Clinical Quality and Patient Safety will report directly to the Chief Executive Officer, ensuring that Clinical Performance and Risk Management are central to the hospital's strategic goals and operations.. The Director will work closely with the Chief Nursing Officer and the Chief Medical Officer to align patient safety and performance improvement initiatives with clinical priorities.. The Nurse Director of Clinical Quality and Risk will enjoy the heart of Illinois, a welcoming community that offers a high quality of life, a low cost of living, and easy access to nearby metropolitan areas.. This hospital recognizes the exceptional value that a talented Nurse Director of Clinical Assurance brings to its healthcare organization.
Signature HealthCARE is a family-based healthcare company that offers integrated services in 7 states across the continuum of care: skilled nursing, rehabilitation, assisted living, memory care, home health, cognitive care, and telemedicine.. Many of our skilled nursing facilities have achieved a 4 or 5-star overall rating from the Centers for Medicare & Medicaid Services.. PINNACLE Workforce Development earn and additional dollar raise each year. Our culture is built on three distinct pillars: Learning, Spirituality and Intra-preneurship.. Each pillar has its own staff and initiatives, ensuring that our unique culture permeates the entire organization.
About the Role: We are seeking a Senior Director, Pharmacovigilance and Drug Safety, Risk Management and Safety Governance , to join Xenon's department of Drug Safety and Pharmacovigilance (DSPV).. This position will lead Xenon's risk management and safety governance strategy and operations by ensuring ongoing compliance with departmental procedures and global drug safety regulations throughout product lifecycle from First-in-Human (FIH) through post-marketing stages of development.. The Senior Director, Pharmacovigilance and Drug Safety, Risk Management and Safety Governance, will engage the Safety Governance Team and lead the development and implementation of any internal procedures, labeling/marketing materials, or reports for Health Authorities that are necessary to ensure the safe use of a Xenon product.. This individual will participate in cross-functional Safety Governance meetings, provide guidance on industry best practices and regulatory requirements for risk management activities, and collaborate with colleagues in Clinical Development, Trial Operations, Regulatory Affairs, Medical Affairs Clinical Pharmacology, Biostatistics & Programming, Quality Assurance, and Legal departments, etc.. G., RN/BSN/MSN, NP, PharmD) and 12+ years of management & pharmaceutical industry experience in Drug Safety & Pharmacovigilance Risk Management for products in the clinical trial and post-marketing environments or MD with 8+years of clinical experience and 6+years of management and pharmaceutical industry experience in Safety Risk Management, while supporting Clinical Development, or Clinical Research and Regulatory Affairs functions is preferred.
Vighter LLC is seeking a Quality Assurance (QA) Assistant in San Antonio, TX. The Quality Assurance Assistant works under the administrative direction of the National Patient Safety and Quality Management Director.. Aligns Quality Assurance activities with the corporate strategy.. A minimum of two years of related experience in a business or healthcare support role.. Proficient in Microsoft Office (Outlook, Word, Excel and Power Point), Apple Mac programs, Adobe Acrobat and social media web platforms.. Must be able to use an elevator or walk up and down stairs.
With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year.. Sr. Principal Scientist - Clinical Pharmacology Study Lead. You will lead the execution of clinical pharmacology studies including bioequivalence, special safety, food-effect, drug-drug interaction, special population, ethnic sensitivity, Absorption, Distribution, Metabolization, and Excretion (ADME) in adult healthy volunteer and patient populations, in addition to pediatrics, to support a diverse pipeline.. Understand mechanism of action, preclinical and early phase safety data, and other compound-specific details within the Investigator Brochure; translate this information to design of clinical pharmacology trials across multiple therapeutic areas.. Doctorate degree (PhD or DNP) OR PharmD OR MD and 2 years of Safety/Pharmacovigilance or Clinical Research experience in a hospital, university or clinical research unit setting.
The Vice President (VP) of Quality & Regulatory Affairs serves as a key member of the executive leadership team at Stony Brook Eastern Long Island Hospital (SBELIH), leading hospital-wide efforts related to quality, performance improvement, regulatory compliance, risk management, HIPAA, and clinical documentation integrity.. Maintain current knowledge of legislative and regulatory changes, informing and guiding hospital leadership accordingly.. Proven experience in hospital risk management, HIPAA, compliance, clinical documentation, and regulatory reporting.. Strong knowledge of NYS DOH, OMH, OASAS, TJC, and CMS regulations.. CPHRM (Certified Professional in Healthcare Risk Management)
A leading clinical research organization dedicated to advancing healthcare through patient-centric clinical trials and studies is looking for a Business Development Director to join the team. A dynamic sales professional with experience in clinical research business development is sought for a full-time, remote role (with occasional travel). This individual will drive new business growth, build strategic partnerships, and expand clinical trial opportunities. Secure new business opportunities in site-based, hybrid, and fully decentralized clinical trials. Proven sales experience in clinical research, with a track record of closing deals.
Signature HealthCARE is a family-based healthcare company that offers integrated services in 7 states across the continuum of care: skilled nursing, rehabilitation, assisted living, memory care, home health, cognitive care, and telemedicine.. How you Will make a difference Provide MDS coverage for open positions, educate and implement programs that apply to the Resident Assessment Instrument (RAI), Prospective Payment Systems (PPS), Quality Measures (QM’s), Medicaid Casemix and Medicare guidelines for all SHC stakeholders.. Assist and collaborate with Clinical Reimbursement Specialist with onboarding of new MDSC.. Exhibit competency in all areas of the RAI, Care Planning, PPS, Medicare, and when applicable Medicaid Case Mix What you Need to make a Difference Current licensure as a Registered Nurse with ability to obtain multi-state licensures.. MDS Float Nurse – Travel Monday–Friday | Mileage & Lodging Reimbursed!
As a Moffitt Clinical Research Coordinator, you’ll bring hope to patients by delivering tomorrow’s cancer treatments today!. Associate Clinical Research Coordinator: Associates degree required, in lieu of Associates degree 2 years of relevant experience with a high school diploma or GED. Experience with data entry, good oral and written communication skills and organizational skills.. Clinical Research Coordinator II: Bachelor's degree with 2 years clinical trials coordination experience.. Clinical Research Coordinator III: Bachelor’s degree with 4 years of experience in clinical trials coordination.. CCRP/CCRC certification required Clinical Research Coordinator Sr.: Bachelor's degree with 6 years of experience in clinical trial coordination.
As part of Mercer, the Government Human Services Consulting (GHSC) team offers its expertise within a small business atmosphere We will count on you to: ·Be a client-facing consultant with expertise in Medicaid facility reimbursement design and rate setting and implementation, with a focus on nursing facility reimbursement.. ·Guide clients in all areas of a reimbursement methodology design, such as: rate setting design and development, Medicaid/Medicare cost report collection, stakeholder partnering, State implementation and operations and establishment of strategic plans/goals, data validation and analysis, and regulation implementation.. ·Some level of nursing home or hospital administration experience.. Mercer, a business of Marsh McLennan (NYSE: MMC), is a global leader in helping clients realize their investment objectives, shape the future of work and enhance health and retirement outcomes for their people.. Marsh McLennan is a global leader in risk, strategy and people, advising clients in 130 countries across four businesses: Marsh, Guy Carpenter, Mercer and Oliver Wyman.
As a not-for-profit organization, Mass General Brigham is committed to supporting patient care, research, teaching, and service to the community. Therefore, we invite and welcome applicants from traditionally underrepresented groups in healthcare — people of color, people with disabilities, LGBTQ community, and/or gender expansive, first and second-generation immigrants, veterans, and people from different socioeconomic backgrounds – to apply. Following established policies, procedures, and study protocols, provides assistance on clinical research studies, including recruiting, evaluating, and consenting patients for studies; collecting and organizing patient data; conducting literature reviews; completing IRB applications, and contributing to manuscript preparation, writing, and publishing of studies related to homelessness and mental illness. Recruiting patients for clinical trials, conducts phone. Assists with regulatory binders and QA/QC Procedures.
Pay Rate: $50 - $55/Hour FUNCTION: Clinical Operations Biomarker and Bioanalytical Operations POSITION OVERVIEW: Clinical Operations is responsible for the worldwide execution of all Phase I - IV clinical trials across all therapeutic areas.. EXAMPLE RESPONSIBILITIES: Leads or manage components of Phase I, II or III studies Assists Biomarker Sciences, Clinical Virology, and/or Clinical Pharmacology in vendor selection and coordinates all interactions and deliverables from vendors.. Participates in the functional review of study protocol and other study related documents such as clinical sample management plan, study communication plan, or presentations for Investigator and/or Study Kick-Off meeting.. MINIMUM EDUCATION & EXPERIENCE: MA/ MS / PharmD / PhD with 2 + years relevant clinical or related experience in life sciences.. Complete knowledge of Food & Drug Administration (FDA) and European Medicines Agency (EMA), and other applicable national regulations, International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) guidelines, Good Clinical Practice (GCP) and key Clinical Operations principles, concepts, practices, standards, processes and tools.
Job#: 2064742 Job Description: Clinical Research Associate 2064742 Location: Boston, MA (Onsite) Focus: Oncology Job Overview: Join our client as the inaugural in-house Clinical Research Associate to oversee quality and patient safety, coordinating with a CRO and facilitating daily study operations.. Build relationships with study sites and vendors, and develop monitoring tools for data review.. Primary Job Requirements: Bachelors degree with 6 years of clinical trials experience Skilled in managing complex oncology studies with a quality and compliance emphasis.. Solid understanding of ICH/GCP, regulations, and relationship-building with sites/vendors.. Willing to travel 50% and adept with Microsoft Office, EDC, CTMS, and eTMF.
Bachelor’s Degree in Health Information Management or Health Informatics OR. B.S. in informatics, computer science, statistics, biomedical engineering artificial intelligence AND certification in Health Informatics.. Minimum 2 years’ experience in clinical research or clinical trials. Experience with clinical operations, Health Information Management, or care management. While there isn’t a fixed requirement for weekly onsite days, candidates should ideally be available to come onsite one day a week, if needed.
AbbVie’s quality foundation resides in the Quality Policy and Quality System as an integrated model in which AbbVie systematically defines quality objectives, both strategic and applicable regulatory requirements.. Director, Safety, Regulatory and Medical Affairs Quality Standards is responsible for the management of a RDQA global Safety, Regulatory Affairs (RA) and Medical Affairs (MA) QA team which provides independent quality oversight of GxP activities, covering the AbbVie drug, device and cosmetic portfolio.. There is an expectation that in performance, leadership, and behaviors (AbbVie's Ways We Work), they serve as a role model to the organization.. Responsibilities: In collaboration with applicable GXP RDQA Leaders, lead, develop and implement routine and QA oversight strategies relating to R&D business stakeholders including but not limited to Pharmacovigilance and Patient Safety, Regulatory Affairs and Medical Affairs to ensure optimal QA oversight and continuous improvement.. AbbVie is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.
We are seeking a dedicated and experienced Director of Behavioral Health Quality Assurance to lead the quality improvement efforts for the Department of Psychiatry in a dynamic healthcare setting. This key leadership role is responsible for coordinating and implementing comprehensive quality assurance, incident review, and utilization review programs across both inpatient and ambulatory care services. Prepare and present data-driven reports to hospital leadership and regulatory bodies.. Master’s degree required (in Psychology, Public Health, Healthcare Administration, or related field).. CPHQ (Certified Professional in Healthcare Quality) highly desirable
Will serve as the Health Policy SME for the program and stakeholders for value-based payment models, Fraud, waste and abuse analytics, quality measures reporting and other clinical or patient safety initiatives. Oversees and manages staffing, recruitment/talent acquisition, finances, ROI, profitability, and operations for the program. Must have adept knowledge of CMS (Centers for Medicare and Medicaid) Value Based Payment Models, as well as experience supporting various aspects of CMMI (CMS Innovation Center). Must have a bachelor's degree in business, project management, healthcare informatics, or related field. You can check to see if your address is located in a HUBZone by accessing the SBA HUBZone Map.
Our hospitals have been named among the Top 5 percent of all U.S. hospitals by Healthgrades and a five-star hospital by the Centers for Medicare & Medicaid Services.. Located just 30 minutes from the beach, TidalHealth offers the widest array of specialty and subspecialty services such as neurosurgery, cardiothoracic surgery, joint replacement, emergency/trauma care, comprehensive cancer care, wound care and clinical trials and research.. The Patient Care Technician provides direct patient care under the supervision of an RN. They perform tasks as delegated by an RN for a broad spectrum of patients as it relates to their age (developmental) and service needs.. Successful completion of a department specific Patient Care Technician Program or completion of Nurse Extern program or 3-5 years of experience as a Patient Care Technician at an acute care facility.. Benefits include medical, prescription, vision, dental, flexible spending accounts, disability insurance plans, life insurance, paid time off plans, retirement plans, tuition assistance, employee assistance, and access to on-site childcare and a credit union
Company OverviewRhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives of people living with rare neuroendocrine diseases.. Responsibilities And DutiesAuthor and serve as lead writer for complex clinical and regulatory documents (e.g., protocols and amendments, clinical study reports, Investigator’s Brochures, regulatory submissions and responses to health authority inquiries) and contribute to the clinical study design and regulatory/clinical strategies.. Ensure accuracy and consistency across clinical, medical, regulatory and pharmacovigilance documents, providing expert review of study and program-level documents (e.g., Regulatory submissions, Annual Reports and updates, DSURs, PBRERs, Posters and Manuscripts).. Delegate, oversee, as needed act as lead Medical Writer, and serve as key communicator and liaison between any vendors or service providers and cross functional internal teams, including clinical, medical, pharmacovigilance and regulatory.. Direct experience in the pharmaceutical/biotech industry with an advanced understanding of requirements for clinical trials and drug development, regulatory submissions, pharmacovigilance reporting and medical communications.
We are seeking a dedicated and experienced Director of Behavioral Health Quality Assurance to lead the quality improvement efforts for the Department of Psychiatry in a dynamic healthcare setting.. This key leadership role is responsible for coordinating and implementing comprehensive quality assurance, incident review, and utilization review programs across both inpatient and ambulatory care services.. Prepare and present data-driven reports to hospital leadership and regulatory bodies. Masters degree required (in Psychology, Public Health, Healthcare Administration, or related field). CPHQ (Certified Professional in Healthcare Quality) highly desirable