Collecting information
Organizing data
Informed by basic research done at our Sloan Kettering Institute, scientists across MSK collaborate to conduct innovative translational and clinical research that is driving a revolution in our understanding of cancer as a disease and improving the ability to prevent, diagnose, and treat it. MSK is dedicated to training the next generation of scientists and clinicians, who go on to pursue our mission at MSK and around the globe. Exciting Opportunity at MSK: We’re looking for a Clinical Trials Nurse in Lymphoma to join our team!. Participate in an individualized training/orientation program geared to teaching or reinforcing the principles of Clinical Trials Nursing practiced at MSKCC. Hours: 4, 10 hour days shifts flexed Monday - Friday, no weekends no holidays
The purpose of the position is to manage and lead the medical, pharmacy and dental billing of third-party payers applicable to outpatient, inpatient, ancillary, ambulatory surgery and professional services.. Minimum five-year experience as a medical billing technician in a tribal or non-profit healthcare patient accounting. Demonstrated knowledge of ICD-10, and CPT/HCPCS coding/billing procedures, Uniform Hospital Discharge Data definitions regarding diagnostic and procedural sequencing in order to interpret and resolve problems based on information derived from system monitoring reports and the UB-04, HCF1500, and ADA billing forms submitted to the third-party. Thorough knowledge of third-party payer rules and regulations (i.e. Medicare, Medicaid, Managed Care, Commercial Insurance, Workers’ Compensation, Motor Vehicle Insurance). Experienced with charge master, EDI claims, medical billing, E.H.R., CCI Edits and Claims Scrubbing, and Insurance Verification of Benefits systems.
Responsible for the strategic development and administration of contracts with State and/or Federal governments for Medicaid, Medicare, Marketplace, and other government-sponsored programs to provide health care services to low income, uninsured, and other populations. Responsible for managing the plan's State healthcare contracts, reviewing and implementing new program requirements and ensuring the plan complies with all health plan contractual and regulatory reporting requirements. Assesses proposed State laws and regulations to determine potential impact and provides written reports of findings to requesting Plan and or MHI corporate staff. Comprehensive knowledge of Medicaid, Medicare, and Marketplace policies and programs. Remote working/work at home options are available for this role.
Communicates with patient, family, physician/Advanced Practice Clinician (APC), and other healthcare providers regarding patient care. Maintains established departmental policies and procedures, objectives, quality assurance program, safety, environmental and infection control standards. Presbyterian employees have access to a fun, engaging and unique wellness program, including free on-site and community-based gyms, nutrition coaching and classes, mindfulness and meditation resources, wellness challenges and more. We are a locally owned, not-for-profit healthcare system comprised of nine hospitals, a statewide health plan and a growing multi-specialty medical group. Our health plan serves more than 640,000 members statewide and offers Medicare Advantage, Medicaid (Centennial Care) and Commercial health plans.
Coordinates performance measurement and improvement activities among all departments including patient safety.. Improves clinical outcomes and patient care related to patient safety with an emphasis on evaluation and improvement of medication administration processes.. Prior experience in quality assurance and utilization management preferred.. Must have knowledge of accreditation standards and current concepts of performance improvement.. A working knowledge of data processing systems and data analysis is required.
Baptist Health is the region's largest not-for-profit healthcare organization, with 12 hospitals, over 28,000 employees, 4,500 physicians and 200 outpatient centers, urgent care facilities and physician practices across Miami-Dade, Monroe, Broward and Palm Beach counties.. With internationally renowned centers of excellence in cancer, cardiovascular care, orthopedics and sports medicine, and neurosciences, Baptist Health is supported by philanthropy and driven by its faith-based mission of medical excellence.. Work within a Nurse-APRN-Physician ambulatory care model.. ACRP Certified Clinical Research Associate. Knowledge of medical terminology, nursing assessment, clinical trials and GCP concepts.
The Regulatory Affairs Specialist 4 performs the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections.. Recommends changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.. Responsibilities are performed through the collaboration with various functions across the business, including but not limited to Regulatory Affairs, Research and Development, Clinical, Quality, and Marketing.. High degree of attention to detail Regulatory Affairs Certification (RAC) is beneficial.. Experience working in regulated medical device industry Experience with 483, warning letter or consent decree remediation efforts preferred Must follow all applicable FDA regulations and ISO requirements.
Department Patient Financial Services Job Summary “Working and Living in Paradise" Come join us in beautiful Sarasota, Florida as part of our Patient Financial Services team for Sarasota Memorial Healthcare System.. At Sarasota Memorial Hospital, you will be a part of a diverse environment where all people are valued and respected.. Problem solves RTP and denied claims and provides support/maintenance for the electronic Medicare billing system.. Require a minimum of four (4) years of Patient Financial Services experience, two (2) of which are in working with Medicare billing and collections.. Some highlights: Total Rewards Package Paid Time Off (start earning PTO on day one of employment) Tuition Reimbursement Discounted Medical, Prescription, Dental, Vision Benefit Plans for Full & Part-Time Employees Flexible Spending Accounts (Health Care and Dependent Care) - Pre-Tax Dollars Life Insurance Competitie rates Bonuses offered Disability Insurance Retirement Savings Plan: 403b Sarasota Campus for now - Discounted Child Care & Before and After School Program and Summer Camp!
The PositionThe Associate/Senior Regulatory Affairs Associate will play a key role in Regulatory Operations, focusing on the collection, preparation, and management of regulatory documents and submissions activities.. Additionally, the Associate/Senior Regulatory Affairs Associate will ensure all regulatory requirements and compliance standards are met throughout the document development and submission process.. Collaborate with external CROs/vendors to faciliate the efficient transfer of clinical trial regulatory submission documents and completed FDA Agency electronic submission documents to electronic document system (i.e., Veeva Vault).. Develop and manage electronic document system tools, including dashboard and reports, in Veeva Vault to enhance submission transparency and streamline efficiency.. Monitor and track regulatory activities, update metadata and attributes in Veeva Vault regularly, and ensure all submission records are accurate, complete, and up to
More than one million people in the United States today are fighting blood cancer.. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.. Summary of Role: As a Specialist, Regulatory Affairs (Clinical focus) at Orca Bio, you will play a pivotal role in coordinating Phase 1–3 clinical trials, managing regulatory submissions, and ensuring compliance with FDA, EMA, and other applicable regulations.. Minimum of 3 years of experience in regulatory affairs, supporting clinical trials.. Preferred experience in oncology and/or cell therapy.
Job Title: Regulatory Affairs Specialist. Industry: Flavor, Fragrance, Food, Brewing, Distilling, Confectionery, Nutraceutical. Schedule: Monday-Friday 8am-5pm, flexible to come onsite as needed, the rest remote work from home. 4+ years of regulatory affairs experience, with knowledge of GFSI, HACCP, Food Safety, Organic, Kosher, and GMO.. Contribute to the development of high-quality food, fragrance, and nutraceutical products.
A generous start-up package including 50% protected research time and access to state-of-the-art resources such as molecular pharmacology, biostatistics, mouse biology, in vivo translational imaging, and biorepository shared resources will be provided.. The incumbent will maintain regular communication with UCDCCC leadership (Director, Associate Directors, Physician-in-Chief), School of Medicine leadership (Vice Deans, Clinical and Translational Science Center, and clinical Chairs), and other key stakeholders (e.g., UCDCCC Internal Advisory Committee, External Advisory Committee, Scientific Council, Community Advisory Board, and the Sacramento City Wide Oncology Phase I Program [SCOPE] Board).. It is a major component of the NCI-designated UC Davis Comprehensive Cancer Center and has a strong presence in developmental therapeutics with an ETCTN grant and as a Lead Academic Participating Site (LAPS) with the NCI National Clinical Trials Network.. The UC Davis Comprehensive Cancer Center is a member of the National Comprehensive Cancer Network (NCCN).. The UC Davis School of Medicine ranks in the top quarter of US medical schools for NIH funding and is among the inaugural Clinical and Translational Award sites.
I. JOB OVERVIEW Job Description Summary: The Senior Financial Analyst, Clinical Research is the primary contact in the GWCC Clinical Trials Office responsible for monitoring funds flow and ensuring the accuracy. This position works collaboratively with SMHS finance and the GWU Office of Clinical Research (GWOCR) in compliance, technical, fiscal, and administrative services required to support cancer clinical trials including, clinical research billing compliance, invoicing, and financial reporting. Assist with monthly billing/invoicing for funded clinical trials verifying financial data for accuracy, completeness and conformance with clinical trial study budgets, includes accurate input of budget and payment milestones into tracking system, must be able to follow monthly tracking of payments and payment issues so that contracts and budgets can be renegotiated if necessary Assist in monitoring outstanding invoices, tracking collection, reducing accounts receivable balance. Follow institutional guidelines and policies in performing Medicare Coverage Analysis (MCA). May assist with negotiations of individual budgets with sponsors, able to challenge claims made by sponsors on what they feel is appropriate, able to cover costs for GW Cancer Center, asking for appropriate funding and being able to say “no” to a sponsor without anxiety or anger, keeping GW competitive with other institutions.
Entry-level position to provide support as needed for basic research, clinical research, or research administration activities. Responsibilities may include tasks related to patient care and supporting patients on clinical trials. Providence Swedish caregivers are not simply valued – they’re invaluable. Join our team at Swedish Research and thrive in our culture of patient-focused, whole-person care built on understanding, commitment, and mutual respect. We take care of you, so you can focus on delivering our mission of improving the health and wellbeing of each patient we serve.
Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. To accelerate and expand its efforts,CRISPR Therapeuticshas established strategic partnerships with leading companies including Vertex Pharmaceuticals. Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Clinical/Translational Pharmacology, Pharmacovigilance, Quality, and external stakeholders as applicable. Solid understanding of the basic principles of biochemistry and molecular biology.. Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
Since its inception over a decade ago, CRISPR Therapeutics has transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. To accelerate and expand its efforts, CRISPR Therapeutics has established strategic partnerships with leading companies including Vertex Pharmaceuticals. Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Clinical/Translational Pharmacology, Pharmacovigilance, Quality, and external stakeholders as applicable. Solid understanding of the basic principles of biochemistry and molecular biology.. Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
The contract Biostatistician will be acting as an independent project-level statistician to support medical affairs/research, commercial, and safety.. This role is responsible for statistical aspects of research questions, for coordinating the analysis, validation, and study documentation, and analyzing data for ad-hoc analyses (associated with pubs or adcomm prep) from all phases of studies.. This position will work collaboratively with clinical development, pharmacology, clinical drug supply, project management, regulatory affairs, medical affairs, market access, safety, medical writing and data management, clinical operations, and especially with programming, and will sometimes collaborate with external statistics and programming vendors.. Work closely with medical affairs, market access, pharmacovigilance, programming, and other biostatistician. PhD degree in Statistics or Biostatistics with some applied statistics training relevant to the clinical trials or health research environment, and with 3 years of relevant work experience OR a Masters degree in Statistics or Biostatistics or a related health science field, and 5 years of biostatistical experience in the clinical trials or health research environment.
, Real World Claims Data, Electronic Health Records/Electronic Medical Records (EHR/EMR), Health Economics & Outcomes Research (HEOR), Social Determinants of Health (SDOH), clinical trials, PubMed, scientific literature and clinical research, genomics / molecular data, patents and funding, Hospital and physician data, Healthcare payer / insurance data, CMS etc.). Serve as the voice of the customer for healthcare/life sciences clients, ensuring our Healthcare and RWD solutions solve meaningful business problems (e.g., market access, HEOR, commercial optimization). Deep understanding of RWD sources (claims, EHR, registries) and related standards (ICD, CPT, NDC, SNOMED, LOINC, etc. Familiarity with tools and programming languages such as SQL, Python, R, SAS, and modern data platforms (Snowflake, Databricks, AWS/Azure/GCP).. Drive the growth of a rapidly expanding data-driven capability in a top-tier strategy consulting firm.
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
Oversee development and implementation of regulatory and other assigned clinical trial documents for GCP compliance and report findings to applicable functional area(s) and the Executive Director.. Help monitor the development, periodic review, revision, approval, version control, and historical archival of controlled documents within the QMS.. Knowledge of and experience with applicable regulatory requirements compliance (e.g. ICH, GCP and FDA) for conducting clinical trials.. With over 35 years of experience, CPC has provided services to over 150 clinical trials in a variety of indications, with an emphasis on cardiovascular, wound healing, diabetes and more.. CPC has expertise in managing clinical trials from a variety of funding sources including industry, NIH, and Investigator Initiated trials.