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Children's Health (Dallas) is seeking a Registered Nurse (RN) Quality Assurance for a nursing job in Plano, Texas. Job Title & Specialty Area: Patient Safety Specialist.. Through our cutting-edge treatments and affiliation with UT Southwestern, we strive to deliver an extraordinary patient and family experience, ensuring that every moment, big or small, contributes to their overall well-being. Adoption and surrogacy reimbursement.. Posted job title: RN Quality Assurance
Voca Healthcare is seeking a travel nurse RN Quality Assurance for a travel nursing job in Rochester, Minnesota. Pay package is based on 8 hour shifts and 40.0 hours per week (subject to confirmation) with tax-free stipend amount to be determined. As a Voca Traveler, you will gain new clinical skills, visit amazing places and meet awesome healthcare professionals. As a travel health professional, your experience and dedication to patient care is in high demand throughout the United States. Voca’s experienced and dedicated travel team works in concert with you every step of the way.
Senior Clinical Research Coordinator - Thoracic Medical Oncology Program. 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.. We combine basic science, clinical research, epidemiology, cancer control and patient care throughout UCSF.. Experience with grant application procedures, personnel documentation, contract generation and subcontracting, preferably at UCSF.Certification by the Society of Clinical Research Associates or the Association of Clinical Research Professionals. 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.
This position works closely with key stake holders including Clinical Operations, Global Planning, Quality Assurance, Regulatory Affairs, Contract Manufacturing Operations (CMO’s), and Contract Research Operations (CRO’s) to ensure seamless supply of Clinical Trial Material. Some key areas of management/oversight include forecasting, packaging, labeling, distribution, inventory management, financial planning/ budgeting, vendor oversight, and eTMF filing of Clinical Supply documents. Managing packaging, labeling, and distribution of clinical trial material for global clinical trials.. · Support (Interactive Response Technology) IRT development, user acceptance testing (UAT), and system oversight, as well as utilize the system to actively manage clinical trial material. NSIDE, Bioclinica, 4G, Oracle, etc)
They have run hundreds of sponsored clinical studies in Phase I - IV in therapeutic areas mainly focused in GI, Hepatology, and CNS!. As a Clinic Manager you will be responsible for directly managing the clinical research team as well as ensuring studies proceed to protocol and regulation. Support and help coordinate clinical trials to ensure studies are completed on time, within budget and in compliance with protocol, standard operating procedures, FDA regulations and ICH/GCP guidelines.. Institutional Review Board and regulatory compliance.. Ensure visit preparedness for all the relevant sponsor and CRO visits and appropriate and timely follow-up on action items.
Supervises daily activities including preparation of solutions, pre-packaging supplies, maintaining inventory levels, filling requisitions delivery of narcotics to nursing units, filling and maintaining of automated dispensing, pre-packaging machines, and preparing sterile products, chemotherapy, etc.. With Assistant CPO, organizes workflow to provide staff pharmacists opportunities to perform clinical pharmacy functions.. Ensures proper storage and security of narcotics and controlled substances.. D. and registration as required by the Commonwealth of Massachusetts and by Newton-Wellesley Hospital.. Knowledge of the special needs and behaviors of infant, child, adolescent, adult and older adult patients preferred.
Participate in the design, planning & conduct of clinical trials program and clinical research projects.. Perform clinical site activities (regulatory issues, patient accrual, patient scheduling & care coordination, data capture & monitoring, adverse events reporting).. Manage tracking & reporting Serious Adverse Events (SAEs) and Adverse Events (AEs).. Prepare and present materials to Institutional Review Board (IRB).. Coordinate performance improvement activities as they relate to clinical trials and research.
At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai’s human health care (hhc) mission.. We’re a growing pharmaceutical company that is breaking through in neurology and oncology, with a strong emphasis on research and development.. · 5+ years of experience in GCP auditing.. · Substantial experience with US, EU, and international regulatory standards and guidelines for the conduct of clinical trials.. E-Verify is an Internet based system operated by the Department of Homeland Security in partnership with the Social Security Administration that allows participating employers to electronically verify the employment eligibility of all new hires in the United States.
Position description DIRECTOR, EARLY PHASE CLINICAL TRIALS & PRECISION THERAPEUTICS, UCI HEALTH Responsible for the development and growth of UCI’s early phase clinical trials portfolio for both oncology and non-oncology indications, across the UCI Chao Family Comprehensive Cancer Center’s (CFCCC) Stern Center for Cancer Clinical Trials & Research (Stern Center), the UCI Center for Clinical Research (CCR), and the UCI Alpha Stem Cell Clinic (Alpha Clinic, AC).. Position the Early Phase Clinical Trials Unit to serve as a hub for precision medicine clinical trials by fostering seamless integration of oncology, genomics, computational biology, pathology, interventional and diagnostic radiology, and medical and surgical specialties. In collaboration with the UCI Health Hematopoietic Stem Cell Transplant and Cell Therapy Program, develop innovative cellular therapies, collaborate in trial design, provide medical expertise, provide feedback on the scientific merit of the trials, and identify unmet medical needs and opportunities for pioneering new technologies. We desire applicants who have evidence of commitment to or strong potential for commitment to the advancement of diversity, equity, and inclusion for underrepresented minority students and groups (Black/African-American, Latino(a)/Chicano(a)/Hispanic, and Native American).. Clinical cancer research includes a large portfolio of early-phase and investigator-initiated trials under the Stern Center for Cancer Clinical Trials & Research, which coordinates all cancer-related trials.
Sr. Manager, Clinical Research Scientist Princeton, NJ, USA •. As a Senior Manager, Clinical Research Scientist, you will play a pivotal role in our mission, leveraging your expertise to drive innovative clinical research and contribute to groundbreaking therapies.. The Senior Manager, Clinical Research Scientist has responsibility assisting in design, execution and reporting of current and future clinical oncology trials ranging from phase 1 - 3.. Use scientific expertise to support the creation of relevant high-quality clinical documents such as study protocols and clinical study reports (CSRs), investigator brochures, DSUR, NDA/MAA registration documents and publications.. At least 2 years in drug development industry in oncology and with previous exposure to clinical development, such as reviewing of the quality of ongoing and final clinical study data, protocols and CSRs, investigator brochures, DSUR, NDA/MAA registration documents and publications.
A leading biopharmaceutical company is seeking a Senior Director, Biostatistics to lead statistical strategy and operations across clinical development programs.. This role will work closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Clinical Pharmacology, Data Management, and Translational Medicine, to ensure the rigorous design, analysis, and interpretation of clinical data.. Lead and mentor the biometrics team, providing strategic input and statistical expertise across clinical programs.. 15+ years of statistical experience in drug development, with at least 10 years focused on oncology.. This position offers an exciting opportunity to play a critical role in advancing oncology drug development within a highly collaborative and innovative environment.
What you'll do: Research and decipher regulatory sources such as legislative rules, state registers, waiver programs and bulletins regarding payment rules for State Medicaid programs as well as deciphering contractual language regarding commercial payment arrangements.. What you'll bring to Zelis:Bachelor's degree or equivalent experience in healthcare administration, business administration, or a related fieldFive+ years of experience in Medicaid billing, reimbursement, claim payment or cost reporting.. Experience with Medicare/Medicare Advantage or commercial billing and reimbursement a plusAbility to manage/oversee pricer program.. Proficient Microsoft Office skills (i.e., functions, macros, pivot tables, data validation, business requirement writing, etc.). Location and Workplace FlexibilityWe have offices in Atlanta GA, Boston MA, Morristown NJ, Plano TX, St. Louis MO, St. Petersburg FL, and Hyderabad, India.
As a(an) Patient Safety Attendant with Mission Hospital you can be a part of an organization that is devoted to giving back!. Referral services for child, elder and pet care, home and auto repair, event planning and more. Healthgrades named Mission Hospital as of one America's 50 Best Hospitals from 2020-2023.. Mission Hospital provides the only open heart and interventional cardiology in the region.. HCA Healthcare Co-Founder
The IT Senior Manager, R&D and Quality Systems is responsible for implementing and supporting R&D and quality business systems required for drug development in the cGMP environment.. This position is responsible for the business analysis, planning, project management, implementation, computer systems validation and ongoing support of business applications in the areas of Research & Development Analytical, Regulatory Affairs, Clinical, Quality Affairs and Quality Control.. Manages the application support of R&D and Quality systems to ensure they meet business needs and user requirements, remains in compliance per cGMP requirements and GAMP5 guidelines.. Experience with R&D, Brand, Quality Assurance / Quality Control, Regulatory Affairs, Clinical, Manufacturing environments regulated by the FDA. Experience with Waters CDS, Trackwise, LIMS, Electronic Regulatory Filing System, Document Management, Quality Systems, Laboratory Operations.
Cardiosense's solutions are built on over a decade of clinical research and we continue to collaborate with the world's leading academic institutions to introduce the next generation of cardiac monitoring and disease management.. Work closely with data science and product teams to define clinical data requirements for AI model validation.. Minimum 8-10 years of experience in clinical research, with at least 5 years in a leadership role managing clinical trials, preferably in the medical device, digital health, or AI/healthcare sectors.. Proven experience designing and executing clinical studies, including model validation trials, for medical AI or digital health products.. Familiarity with AI model validation methodologies, particularly in healthcare applications.
PhD with at least 7 years of professional experience in QA/QC pharmaceutical manufacturing or;. Master’s degree with at least 9 years of professional experience in QA/QC pharmaceutical manufacturing or;. Bachelor’s degree with 10 years of professional experience in QA/QC pharmaceutical manufacturing.. Experience leading audit preparations, electronic quality management systems such as deviation management, analytical investigations (OOS), CAPA and change control.. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market.
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
to lead statistical strategy and operations across clinical development programs.. This role will work closely with cross-functional teams, including Clinical Development, Regulatory Affairs, Clinical Pharmacology, Data Management, and Translational Medicine, to ensure the rigorous design, analysis, and interpretation of clinical data.. Lead and mentor the biometrics team, providing strategic input and statistical expertise across clinical programs.. 15+ years of statistical experience in drug development, with at least 10 years focused on oncology.. This position offers an exciting opportunity to play a critical role in advancing oncology drug development within a highly collaborative and innovative environment.
Provide internal and external consultancy on safety issues related to Pharmacovigilance and Patient Safety activities (processing safety and epidemiology reports, providing benefit-risk assessments, signal detection and investigations). Act as an expert to department and organization members regarding risk management, insurance, legal and regulatory matters. MD or an advanced degree in Pharmacy or Health Sciences (PharmD, PhD). Extensive professional experience in pharmacovigilance and clinical safety and understanding of clinical research development. Experience in clinical trials from CRO or pharma/biotech company or as an investigator
The company is also recruiting for talented scientists who have deep knowledge in immunology, translational science, bioinformatics and biologics platforms to develop novel drugs leveraging disease-driving biology, novel technology in protein engineering, antibody discovery and new modalities.. Data Analysis and Interpretation Oversee the analysis, interpretation, and reporting of in vitro and in vivo pharmacology/translational biomarker data, including pharmacokinetic and pharmacodynamic parameters, exposure-response relationships, and safety/tolerability profiles.. Cross-Functional Collaboration Collaborate closely with colleagues in data sciences, biologics, immunology/pharmacology, clinical development, clinical operations and regulatory affairs to integrate translational biomarker and mechanism of action insights into overall drug development strategies.. M.D or Ph. D. in oncology, immunology, immuno-oncology, pharmacology, pharmaceutical sciences, or a related discipline.. Experience with immuno-oncology and autoimmune disease/chronic inflammation targets and associated in vitro and in vivo models.