Healthcare & Pharma Careers

The Quality Engineer is responsible for supporting and improving the current Quality Systems within the Madison, WI manufacturing facility.. This position will have a wide range of tasks which may include product complaint investigations, root cause analysis (RCA), manufacturing quality process development, maintenance, trending and reporting, deviation investigation, CAPA management, change management, internal/external auditing, supplier quality management, and direct involvement and collaboration with the Operations, Technical Operations, Engineering, and Materials Management groups to drive quality culture.. Support supplier quality management with respect to desk audit and quality agreement creation, execution and review via direct customer contact. Statistical analysis – Minitab or other software equivalent, preferred.. The Quality Engineer collaborates closely with Manufacturing, Quality Control, Facilities, Materials Management, Regulatory Affairs, and Process Development.

Summary Position SummaryThe Research Support Analyst manages the Clinical Trial Management System (CTMS) to support sponsored studies from pre award to post award for the department of Clinical Research.. This position will require knowledge of data collection related to accruals and be responsible for budget builds and financial monitoring of sponsored trials.. This position will be expected to be a super user of the Clinical Trial Management System (CTMS) and will be responsible for maintaining the study portfolio in the CTMS which includes support in the following areas: financials, Medicare coverage analysis, accrual and data reports, study builds, and study amendments.. This position will be responsible for billing review for clinical trials patients based on Medicare Coverage rules and Clinical Trial contracts to ensure proper compliance and reimbursement.. This position requires advanced knowledge of research program billing requirements, as well as Medicare, Medicaid, and federal research billing rules.

Follows all aspects of Standard Operating Procedures and Good Clinical Practices in the conduct of clinical research; collects and prepares documents as required by sponsoring agencies; attends Investigator Meetings, as assigned. Understands and can conduct clinical research studies that require but not limited to Emergent Access/Compassionate use, Multi-site clinical trials, conduct Investigator Initiated studies, Research Team training manuals. Participates in training nursing and ancillary study staff for study purposes; builds relationships with various departments to ensure protocol compliance.. Completes Case Report Forms; responds to sponsor queries, prepares for audits by sponsor, IRB and/or the FDA/DHHS.. Minimum 2 years experience as a Clinical Research Nurse I or Clinical Research Coordinator I.

Job Summary The division currently seeks a Clinical Research Technician to support our growing and exciting clinical research program that includes a portfolio of clinical trials and patient-oriented observational studies.. Our studies include the full spectrum of chronic kidney disease (CKD) and its complications (cardiovascular, mineral-bone disorders, musculoskeletal and other disorders) as well as in the kidney transplantation population.. The Clinical Research Technician will have the opportunity to work with various Principle Investigators (PI) in the division and participate in continuing education.. Job Classification Career Level: IntermediateFLSA: NonexemptJob Function: ResearchJob Family: Clinical Research Click here to learn more about Indiana University's Job Framework.. Indiana University does not discriminate on the basis of sex in its educational programs and activities, including employment and admission, as required by Title IX. Questions or complaints regarding Title IX may be referred to the U.S. Department of Education Office for Civil Rights or the university Title IX Coordinator.

The Clinical Research Coordinator (CRC) is a professional working under the direction of their Novant Health leader in conjunction with study investigators.. Clinical Research Coordinator I RN. Clinical Research Coordinator II RN. Clinical Research Coordinator III RN. Clinical Research Coordinator IV RN

Through our vision to become the most trusted partner in healthcare, we offer a diverse portfolio with solutions in the therapy areas of anesthesia, emergency medicine, interventional cardiology and radiology, surgical, vascular access, and urology.. The role of the Senior Regulatory Affairs Specialist is focused on supporting material cost improvement projects that will shift this dynamic, reduce costs, and enhance product margins.. The Senior Regulatory Affairs Specialist will develop strategies and submissions for Material Cost Improvement Projects (CIP) and address issues related to regulatory documents, submissions, investigations, product development planning, and regulatory agency interactions.. Provide Regulatory support for Material CIP projects, input and approval for new supplier changes.. Identify key risks on Material CIP programs and communicate appropriately into the Program Lead to ensure all RA impacts are captured in each project.

Participate in study start up activities.. Maintain and audit Trial Master File to ensure inspection readiness.. Involved in the preparation of all applicable documents required for the conduct of the study (such as Trial Master File (TMF), Clinical Protocols and Reports).. May interact with RA/QA in responding to audits and FDA inquiries Skills: BS degree in life sciences with three years of experience as a CRA or CRC or combination of appropriate education and experience required.. Working knowledge of GCP, Clinical and Regulatory Affairs.

Title: Configuration Analyst (Facets, SQL -Medicare/Medicaid Programs) - Hybrid. SQL, Database ,. Healthcare claim, benefit configuration,. Facets platform, Medical Plan Benefit Configuration, Provider Network & Agreement Con

Job DescriptionGeneral SummaryUnder limited supervision, and with the latitude for initiative and independent judgment, performs, coordinates, and manages the creation and outsourcing of billing analysis in accordance with the Center for Medicaid and Medicare Services (CMS) regulations and the Clinical Trial Policy for all clinical trials.. The billing analysis must be compliant with the Medicare billing rules.. Performs basic and complex billing and budget analysis in accordance with CMS regulations for all clinical trials performed at UMMS affiliates and FPI practice offices and clinics.. Applies the appropriate CDM and/or CPT codes for potentially billable items in the coverage analysis in order to assist in the management of claims review, as well as identifying items that are to be billed to the sponsor via the budgeting and contract teams at the Office of Research and Development (ORD) at University of Baltimore (UMB).. QualificationsEducation and ExperienceBachelor’s degree in Healthcare Administration, Medical Coding, Auditing, Finance, Accounting, Nursing, or a related field required.

Established in the United States in 1989, Tosoh Bioscience has become known throughout the Americas for providing sophisticated diagnostic systems to doctor's offices, hospitals and reference laboratories.. The Quality Manager assists in the implementation, management and continuous improvement of the TBI Quality System and leads and provides cross-functional engineering support to Operations, Facilities Control and Manufacturing Project teams through system validations and data monitoring.. Reporting Relationships The Quality Assurance Manager will report to the Senior Manager, Quality Systems and Compliance.. Other duties as assigned, according to the changing needs of the business Education Bachelor’s degree in industrial technology, Biology, Chemistry, Biochemistry, Electrical/Electronic/Mechanical or Bioengineering.. Understanding of quality concepts such as: cost of quality, analytical metrics, statistics and trending, quality planning, validation, CAPA and problem solving Management of third party audits/inspections, internal audits, supplier audits, document control, change control, training, NC/CAPA, quality agreements, training employees.

A new and exciting position has opened for a Pharmacy Operations Director at a community hospital serving the Olympic Peninsula.. This Pharmacy Operations Director will join a comprehensive community medical center serving the residents of the Olympic Peninsula with a commitment to high-quality care.. The Pharmacy Operations Director will report directly to a senior hospital executive, providing a vital link to leadership.. The scenic coastal area offers an unparalleled blend of natural beauty and vibrant community life with plenty for a new Pharmacy Operations Director to explore.. Outdoor enthusiasts can enjoy hiking, kayaking, and exploring Olympic National Park, while the town s thriving arts scene, farmers' markets, and welcoming culture provide year-round enrichment.

Participate in study start up activities.. Maintain and audit Trial Master File (TMF) and upload to eTMF to ensure inspection readiness.. BS degree in life sciences preferred or equivalent with minimum 2 years of as a CRA/CRC/CTA experience, or combination of appropriate education and experience.. Experience in conducting medical device studies and/or in-vitro diagnostics studies preferred.. Working knowledge of CFR, ICH-GCP, Clinical and Regulatory Affairs

The Clinical Research Division at The IMA Group is a dynamic hub of expertise and innovation, dedicated to advancing healthcare through clinical trials and studies.. Committed to ethical practices and regulatory compliance, we aim to pioneer groundbreaking medical solutions that shape the future of healthcare.. IMA Clinical Research is seeking a Site Manager that will be responsible for the day-to-day management of clinical research activities at assigned sites.. Education: Bachelor’s Degree required; Master’s Degree, RN, Nurse Practitioner license, PC, CCRC, or CCRP certification preferred.. Our Clinical Research Division performs all types of Phase II-IV clinical trials in multiple therapeutic areas through a flexible nationwide network of site locations and virtual capabilities.

Design PoM, SoCA or POC studies in consultation with KOLs and Pfizer project team members (Stats, Clin Pharm, Regulatory, Operations, etc. Develop the primary and secondary endpoints for efficacy and safety and contribute to the precision medicine and biomarker strategy as well as to the biostatistics analytic plan that is aligned with the transition target product profile.. Develop effective collaborations with research project leaders and projects team members, including biostatistics, regulatory affairs, clinical pharmacology, clinical scientists and development operations.. QUALIFICATIONS Education: Requires MD or MD/PhD, Immunology, Inflammation and Neurology specialty required, but other specialists with experience in GI, Rheumatology, Allergy and Hematology clinical trials will be considered.. Good understanding of relevant areas such as biostatistics, regulatory, clinical pharmacology, pre-clinical toxicology, pharmacogenomics and biomarker-based approaches.

Collaborating (and representing the Market Access & Strategy Team) with other teams and departments to mitigate or resolve issues and barriers related to the performance and billing of laboratory testing and related patient services.. Maintaining current knowledge of official health care billing and coding guidelines and national trends, including those from the Centers for Medicare and Medicaid Services (CMS) and other agencies within the Department of Health & Humans Services (HHS).. Bachelor’s degree in business administration or relevant areas as outlined by essential duties; 8+ years of experience advising health care organization(s) on legal, regulatory and strategy topics related to government and commercial insurance coverage, billing and reimbursement, fraud/waste/abuse, provider licensing, and patient/consumer protection.. Advanced knowledge and understanding of official health care billing and coding guidelines, including those from the Centers for Medicare and Medicaid Services (CMS) and other agencies within the Department of Health & Humans Services (HHS).. Experience with unique provider-payer contracting arrangements, including value-based care.

QUALIFICATIONS/EDUCATION:Certified Professional Coder Certification Bi-lingual English/Spanish preferred; must be able to read, write and speak English.. 3+ years of experience in Managing a Medical Billing Department.. Moderate computer knowledge: MS Word and MS Excel, internet, document with Electronic Health Records and/or authorization system with minimal typing/spelling errors, send e-faxes and email.. Clinical Care Medical Centers believes that diversity and inclusion among our employees is critical to our success as a company.. We support an inclusive workplace where employees excel based on personal merit, qualifications, experience, ability, and job performance.

Extract, clean, and analyze data from electronic health records (EHR), financial systems, and other sources.. Assist with data submission for regulatory reporting and compliance requirements (e.g. Medicare, Medicaid, UDS reports).. Proficiency in SQL, Excel, and data visualization tools (Power BI, Tableau, or similar).. Familiarity with electronic health records (EHR) systems, particularly Cerner, Epic, Meditech is a plus.. Knowledge of healthcare data standards and regulatory requirements (e.g., HIPAA, HEDIS, UDS).

The Clinical Research Supervisor Non-RN serves the AdventHealth Research Institute (AHRI) providing oversight of the conduct of industry-sponsored and investigator-initiated clinical trials in accordance with trial protocols, Food and Drug Administration (FDA) regulations and International Conference on Harmonization/Good Clinical Practices (ICH/GCP) guidelines.. The Supervisor is able to function as a clinical study coordinator as needed and serves to train, mentor and develop the clinical study coordinators and research staff in the conduct of clinical research within the AdventHealth research enterprise at the institute level and may extend across multiple U.S. Division locations.. Delivers effective and compliant clinical research study coordination as necessary, based on the needs of the department, including planning, organizing, and managing all activities related to clinical research protocols and execution of timelines, for industry-sponsored and investigator-initiated clinical trials.. Serves in a supportive role for the preceptorship of new team members, which would be inclusive of monitoring the progress of each new team member and providing open communication to the Operational Manager for workflow planning.. Certified Clinical Research Coordinator (CCRC) (per the Association of Clinical Research

With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.. RequirementsJob OverviewThe Clinical Research Coordinator II (CRC II) is a lead coordinator on multiple surgical services (General Surgery, Burn, Breast, Endocrine, Trauma, Colorectal, and Surgical Oncology) and possibly transplant clinical research studies, under the oversight of the Principal Investigator (PI) and direct supervision of the Clinical Research Nurse Manager in collaboration with a Research Director.. Work Interactions and Work Mode DesignationThe Clinical Research Coordinator II works under the direct supervision of the Clinical Research Nurse Manager in collaboration with the Research Director and conducts the studies under direct oversight of the Principal Investigators (PIs).. They work within the multidisciplinary team of the healthcare system and the university medical center, including the clinical research office, sponsored programs financial office, research development services, respective grants managers, and serve as primary point of contact with the sponsors, CROs, and IRBs. Requirements and QualificationsBachelor's degree in a scientific or related field with at least 3 years CRC I or equivalent clinical research experience.. Working knowledge of clinical trials contracting and budgeting, including understanding of Medicare Coverage Analysis (MCA) and clinical trials billing compliance, both industry and non-industry.

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.. A growing number of our centers are earning quality assurance accreditation and pioneering person - directed care.. Many of our skilled nursing facilities have achieved a 4 or 5-star overall rating from the Centers for Medicare & Medicaid Services.. With FLEXpath at Signature Healthcare, about the only thing that isnt flexible is our commitment.. At Signature Healthcare, were leading a revolution in elder-care, one shift at a time.