Collecting information
Organizing data
The Quality/PI Supervisor is also responsible for developing, implementing, coordinating, and monitoring performance improvement strategies to improve patient safety, establish evidence-based care, and meet organizational goals.. Collaborates with leaders, physicians, nurses, allied health professionals, and support staff to develop performance improvement initiatives that address quality of care opportunities.. Utilizes evidence-based clinical guidelines and best practice to guide process improvement related to targeted clinical diagnoses, regulatory requirements, and patient safety.. Supports patient safety program in collaboration with the Quality and Patient Safety Department, Regulatory Affairs, and Risk Management and Medical Staff Services.. Knowledge of Joint Commission and Centers for Medicare and Medicaid Services regulations/requirements preferred.
Finally, Lehigh Valley Hospital - Cedar Crest, Lehigh Valley Hospital - Muhlenberg, Lehigh Valley Hospital- Hazleton, and Lehigh Valley Hospital - Pocono each received an 'A' grade on the Hospital Safety Grade from The Leapfrog Group in 2020, the highest grade in patient safety.. Plans, initiates, coordinates, implements, and oversees clinical trials in the ASR division of the Network Office of Research and Innovation.. Plans, implements, and conducts approved clinical research trials by coordinating and managing the patient assessments, phlebotomy, drug administration, and monitoring of side effects according to protocol standards in a clinically safe and regulatory compliant manner involving research patients who have multiple disease processes to ensure timely, high quality care across the care continuum.. Assists with NORI/IRB submissions and maintenance of regulatory and legal documents; maintains required documentation for clinical trials.. CCRC-Cert Clinical Research Coordinator ACRP - State of Pennsylvania Upon Hire
The Patient Care Coordinator is responsible for overseeing the management and coordination of care for the acute inpatient population.. The PCC collaborates with rounding MAPMG Hospital Based Service Physicians, patient/family, nursing, utilization review and other members of the healthcare team to assure continuum of patient care progression for clinical and cost-effective outcomes.. Send referrals/communicate with in-network vendors for coordination of post-acute levels of care such as Home Health, DME, IV infusion, SNF, Sub-Acute and Acute Rehab.. Some awareness or knowledge of health/care reimbursement systems (Medicare Advantage, Commercial payer, Medicaid and CMS regulatory rules).. Annually: Successful completion of PCC Assessment of Critical Skills, Passing score on inter-rater reliability.
The Manager of Specialty Pharmacy Operations is responsible for overseeing the strategic, financial, and operational aspects of client specialty pharmacy services. Oversee daily specialty pharmacy care coordinators, ensuring efficiency, accuracy, and compliance. Education: Bachelor’s or Doctor of Pharmacy (PharmD) required; Master’s in Business Administration (MBA) or Healthcare Administration (MHA) preferred. Experience: Minimum 7–10 years of experience in pharmacy operations, including at least 5 years in a leadership role in specialty pharmacy. Strong understanding of specialty pharmacy regulations, payer models, and accreditation standards.
Must have Long Term Care/ Skilled Nursing Facility Medicaid Billing Experience. The Medicare / HMO Biller is responsible for managing and processing Medicare/ HMO billing for a nursing home facility in compliance with state and federal regulations.. - Verify resident eligibility and ensure accurate documentation for timely Medicaid billing.. - Provide regular updates to the Regional Business Office Manager on billing performance and issues.. - Provide Monthly updates to Regional Business Office Manager, CEO and COO on amounts of claims filed.
Centessa Pharmaceuticals plc (Nasdaq: CNTA) new kind of pharmaceutical company with a deconstructed R&D environment that prioritizes data driven decision making led by subject matter experts.. The Associate Director, Clinical Quality Assurance (CQA), will be responsible for all aspects of Quality Assurance focused on Good Clinical Practice (GCP) activities to ensure quality assurance and compliance of Centessa sponsored clinical trials (Early-Late Phase) with applicable GCP regulations (e.g., FDA, ex-US, country-specific), ICH GCP guidelines, Centessa Standard Operating Procedures (SOPs), and current industry standards and practices.. Support GCP audit program to include routine and non-routine quality assurance audits of clinical investigator sites, vendors, processes, systems, and study documents to ensure integrity and accuracy of study data and assure quality compliance with internal procedures as well as regulatory guidelines.. Provide Clinical QA oversight of GCP protocols, Informed Consent Forms (ICFs), Clinical Study Reports (CSRs), and other clinical trial specific documents as requested.. Proficiency in using Veeva and Microsoft Office applications required (MS Word, MS Excel, MS PowerPoint).
As the Director, Regulatory Labeling, reporting to the Vice President, Regulatory Affairs and Quality Assurance, you will lead the development of labeling for clinical supplies as well as development of commercial labeling materials for Olema products. This role requires a solid understanding of global labeling requirements, labeling platforms, and print production processes to effectively manage end-to-end label implementation. This role will work closely internally with Regulatory Affairs, Clinical Development, Clinical Supply (CS), Quality Assurance (QA), and the CMC teams as well as external vendors (clinical research/development and manufacturing organizations) to ensure appropriate quality control checks are proceduralized and implemented for all labeling activities. Serve as a strategic cross-functional partner working closely with the CMO/CRO labeling specialists, cross-functional project teams including Quality, Regulatory, Clinical Supply, and CMC teams. 10+ years of experience working in clinical research, biotech, and/or pharmaceutical company, with 8+ years of Regulatory Affairs experience within clinical research or pharmaceutical.
GSK is seeking a dynamic and experienced Executive Medical Director, Clinical Research for Hepatology Clinical Trials to lead our clinical development programs within the hepatology therapeutic area.. This career opportunity requires an on-site office presence (minimum of two days a week) in one of GSK's UK (London - New Oxford Street or Stevenage) or US(PA or MA) sites.. Oversee the development and implementation of clinical trial protocols, ensuring alignment with regulatory requirements and GSK's scientific standards.. GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive.. GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
The Director will be the Category Leader for the category assigned to them within the Strategic Sourcing and Procurement (SS&P) department. This individual will be the key point of contact for their category and will be responsible for providing strategic leadership, operational oversight, and administrative/HR management for direct reports and extended leadership for indirect reports. The Director, Sourcing will be a Category Leader for the Development Category encompassing Clinical Labs, Clinical Pharmacology, Translational Research, Global Patient Safety, Regulatory Affairs, Medical Affairs, Clinical Development, and Biometrics. This role will support outsourcing needs to advance Exelixis R&D efforts, including services such as consulting, medical science liaison, pharmacovigilance, quality assurance, central labs, local lab results integration, PK and immunogenicity bioanalysis, biomarker assays, ADME studies, and toxicology. Deep knowledge of outsourcing concepts, financial processes, contracts, regulations (FDA, EMA, ICH GCP), and industry standards.
This individual will partner with CMC, Clinical, Regulatory Affairs, and other corporate stakeholders to ensure Company’s clinical and commercial products follow cGMP framework and guidelines.. The Associate Director, Quality Assurance will be based in our Northern New Jersey, offices 1 - 2 days a week (flexible schedule for the ideal candidate).. Key Responsibilities Provide quality leadership, strategy, and compliance oversight to CDMOs, CMO, CRO, CPO, Third Party Vendors.. ·Performs disposition activities for manufactured products in support of clinical products, including MBR, EBR review, and approval and review of CoA. Responsible for Management and maintenance of the Veeva Quality Docs System, including document drafting/Authoring, reviewing, approving, and finalizing internal quality documents (SOPs, Wis, Policies, Forms, etc.). Ideal candidate will have extensive CMC (Organic and/or Analytical chemistry) experience with at least 10 years in CMC-QA leadership roles.
Research and decipher regulatory sources such as legislative rules, stateregisters, waiver programs and bulletins regarding payment rules for State Medicaid programs as well as deciphering contractual language regarding commercial payment arrangements.. Bachelor’s degree or equivalent experience in healthcare administration, business administration, or a related field. Five+ years of experience in Medicaid billing, reimbursement, claim payment or cost reporting.. Experience with Medicare/Medicare Advantage or commercial billing and reimbursement a plus. Proficient Microsoft Office skills (i.e., functions, macros, pivot tables, data validation, business requirement writing, etc.)
Our employees are our greatest asset as we work to achieve our bold ambitions, and we’re looking for the next wave of passionate and ambitious people ready to make a direct impact.. Regulatory Affairs Global Labeling is a core function within Gilead's Global Regulatory Affairs organization and acts as a critical strategic partner across cross-functional teams.. Regulatory Affairs Global Labeling creates, updates, and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio to ensure Gilead's ongoing compliance with governing laws, regulations, and company policies and procedures.. Oversees and guides or otherwise leads review/approval of U.S. labeling in Structured Product Labeling (SPL) format, artwork requests, archiving labeling documents, and updating label histories.. PharmD/PhD with 6+ years’ relevant experience.
Who we areWe're a global, midsize CRO that pushes boundaries, innovates and invents because the path to a cure for the world's most persistent diseases is not paved by those who play it safe.. Assists with creating and presenting GCP/GLP and other related training sessions.. What you will bring to the role Sound knowledge of applicable GLP/GxP. Your experience Bachelor's degree or higher in life science or equivalent experience gained by working in a relevant area (clinical setting, laboratory, etc. Minimum 5 years' experience in regulatory affairs, auditing, clinical research, monitoring, laboratory, or other relevant area, of which 3 are in quality assurance auditing.
Advisor - Clinical Research Scientist - Neuroscience Clinical Development: Neuropsychologist Join to apply for the Advisor - Clinical Research Scientist - Neuroscience Clinical Development: Neuropsychologist role at BioSpace.. Join to apply for the Advisor - Clinical Research Scientist - Neuroscience Clinical Development: Neuropsychologist role at BioSpace.. With the expansion of the Lilly portfolio, this role will be responsible for scientific support for clinical trials across the Neuroscience platform and serves a spectrum of patients with neurological and psychiatric conditions. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Medical Science Liaison, Autoantibody Pipeline (Central) Licensed Life and Health Insurance Advisor Advisor / Sr. Advisor - Good Clinical Practices - Quality Assurance Indianapolis, IN $121,500.00-$198,000.00 2 weeks ago
UNIV - Quality Assurance Auditor and Education Specialist - Hollings Cancer Center. The Internal Quality Assurance Auditor and Education Specialist is a key member of the Clinical Trials Office (CTO), responsible for implementing research quality assurance measures and overseeing education, orientation, and ongoing professional development.. Quality Assurance Internal Auditor (35%) : Conduct audits of clinical trials to ensure protocol compliance, including audits of national trials, Phase II, high-risk, and FDA registration trials.. Prepare reports, communicate findings, and ensure adherence to GCP, IRB, and CTO regulations.. Education Specialist (35%) : Train staff on SOPs, IRB policies, GCP, and ICH guidelines.
The Manager, Medical Affairs is accountable for establishing, nurturing, and maintaining strong collaborative relationships with critical WWM colleagues (such as Clinical Research, HEOR/RWE, Global Patient Safety, and WWM Strategy and Delivery) as well as cross-function partners (such as R&D, Marketing, Quality) to enable a highly efficient and effective working environment. Provide accurate, balanced and timely clinical expertise to functional areas such as clinical development, R&D, marketing, manufacturing, quality assurance, regulatory affairs, and legal based on objective evidence and, clinical experience. Coordinate with other Medical Partners (e.g., Clinical Research, Clinical Operations, HEOR, Regional Medical, etc. NP/PA/MD with primary and/or acute care experience such as ER, Urgent Care, or Hospitalist/internal medicine is ideal. Optometrist who displays sophisticated knowledge of physical assessment will be considered.
Act as a clinical resource and educator, supporting the onboarding and ongoing development of new clinical research staff such as treatment room nurses, LVNs, and study coordinators.. Foster cross-department collaboration with regulatory, quality, pharmacy, site development, and finance teams, ensuring effective use of CTMS/EHR systems and full compliance with GCP, federal, and sponsor requirements.. Knowledge of GCP, GDPR and federal clinical research regulations required in US and Europe.. Deeply rooted in community oncology centers globally, The START Center for Cancer Research provides access to specialized preclinical and early-phase clinical trials of novel anti-cancer agents.. As our Director of Nursing, you'll be at the forefront of innovative cancer research, directly impacting patient outcomes and advancing the future of oncology care.
Reporting to the Clinical Manager of Ultrasound, the Quality Assurance (QA) Specialist facilitates the US QA program and provides appropriate education to the staff which includes assessing, planning, implementing, and evaluating both orientation and continuing education programs to enhance the quality of patient care services.. In conjunction with the Clinical Manager and Assistant Clinical Director (ACD), assists with third party accreditation processes, including but not limited to, The Joint Commission (TJC), Department of Public Health (DPH), Centers for Medicare/Medicaid Services (CMS).. Collaborates with the ACD for accreditation and maintains quality assurance to meet third party agencies, including but not limited to TJC, DPH, CMS.. Performs high quality exams, has an in-depth knowledge of anatomy and physiology can operate and utilize all types of ultrasound related equipment and supplies.. Graduate of an accredited school of Diagnostic Medical Sonography and/or Imaging Program with 3-5 years of experience as an ultrasound technologist.
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).. A background in Health Informatics is ideal for success in this position.. Must have a bachelor's degree in business, project management, healthcare informatics, or related field.
It has direct responsibility for implementing a diverse portfolio of research activities for one or more studies which may include multicenter clinical trials (both NIH and industry-sponsored), local investigator-initiated clinical trials, and/or programmatic clinical research activities, such as a clinical database and biorepository.. The UCSF Helen Diller Family Comprehensive Cancer Center (HDFCCC) is one of only two cancer centers in the Bay Area to receive the prestigious designation of “comprehensive” from the National Cancer Institute (NCI).. 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.