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Denali Health is seeking a Clinical Research Coordinator I to join our dynamic and mission-driven research team in Plant City, Florida. This is an incredible opportunity for International Medical Graduates (IMGs), Certified Nursing Assistants (CNAs), or Medical Assistants (MAs) who want to grow in the field of clinical research. Our site in Plant City focuses on high-impact studies across neurology, endocrinology, psychiatry, and more. As a Clinical Research Coordinator I, you will play a hands-on role supporting clinical trials from start to finish. Coordinate day-to-day study activities in compliance with protocol, GCP, and FDA regulations
Overview The work of this position is performed at St. Francis Hospital in Hartford, CT. The Clinical Research Nurse II (CRN II) is responsible for providing research services to patients participating in clinical trials within the Yale Cancer Center Clinical Trials Office, while ensuring safe, compliant, efficient, and effective conduct of clinical trials. Knowledge of Food and Drug Administration (FDA) regulations, Good Clinical Practice (GCP) guidelines, and other applicable federal regulations. Adheres to study protocol, maintains accurate documentation, recruits study participants, and ensures regulatory and protocol requirements and guidelines are met per ICH/GCP, federal regulation, and institutional and sponsor requirements. Reviews Beacon order set with CRC in anticipation of upcoming participant's clinic visit. Required Education and Experience Graduate of an accredited nursing program and minimum three (3) years of related nursing experience in a hospital, clinic, or similar health care setting required or 3 years of clinical research nurse experience, or equivalent combined experience, or the equivalent combination of education or experience.
Provide skilled nursing care, including wound care, medication administration, and IV therapy. Accurately document patient care using electronic health record (EHR) systems. Current Registered Nurse (RN) license in the state of practice. Home Health Nurse certification preferred. Understanding of Medicare and Medicaid guidelines for home health services
The Senior Director (Senior Principal Scientist) has primary responsibility for planning and directing clinical research activities involving new or marketed cardiovascular and respiratory medicines.. Work closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects. Minimum of 3-5 year of industry experience in drug development or biomedical research experience in academia. A proven track record in clinical medicine and background in biomedical research is essential. Board Certified or Eligible Cardiologist or Pulmonologist
This position requires deep understanding of all aspects of the drug development process from early clinical stages to post commercialization; with emphasis on the large global clinical trials and regulatory filing activities. A clinician (M.D., or D.O.) preferably a psychiatrist or neurologist including prior management experience (direct or indirect). Requires thorough knowledge of clinical medicine and/or clinical pharmacology and associated disciplines (e.g. biostatistics, data management, medical writing). Advanced understanding of drug development principles and clinical trial implementation and management. If you believe you are the victim of fraud resulting from a job recruiting scam, please contact the FBI through the Internet Crime Complaint Center at: , or your local authorities.
Ensures successful completion of all internal and external audits, assists Clinical Research Coordinator (CRC) with regulatory compliance, maintains staff credentials, provides Quality Control of all source documents, conducts chart review, and updates SOPs as necessary.. Quality Assurance Specialist (Chemicals)QA Associate, Quality Compliance (Generic Pharma). PRN / Quality Assurance Specialist - Safe Kids Worldwide (Child Passenger Safety Exp Desired). Quality Assurance Specialist, World Bank Third Party Monitoring, Various LocationsTravel Quality Assurance Analyst (Quality Assurance, Associate). Quality Assurance Specialist Records ManagementQuality Peer Review Quality Assurance Full Time Day Shift
The preferred candidate will have expertise in multiple therapeutic areas, including metabolic diseases and obesity, and across drug modalities, and have led regulatory filings for IND and CTA opening studies.. Plan and execute regulatory agency engagements, such as pre-IND/CTA and scientific advice meetings, serving as the primary contact with agencies like the FDA.. Advanced degree (Ph. D., PharmD, M.D., M.S., or equivalent) in a relevant scientific discipline such as pharmaceutical sciences, regulatory science, or life sciences.. Minimum of 12 years in the pharmaceutical or biotechnology industry, with at least 10 years in regulatory affairs roles.. Prior involvement in metabolic diseases, immunology, or rare disease drug development is highly desirable.
Key areas of focus include vendor management, cross-functional collaboration, and driving the in vivo and in vitro strategy across the pipeline.. Identify and implement preclinical models that reflect patient pathology; develop assays to support in vitro and in vivo assessments of efficacy or relevant biomarker activity.. Lead and oversee in vivo preclinical safety, PK/PD, and potential efficacy studies.. Define preliminary dosage and dosing regimens based on in vitro and in vivo data; partner with CMC and device teams to ensure feasible delivery approaches.. Ph. D. in Pharmacology, Pharmacokinetics, Biology, or related scientific fields.
Medication Access Coordinator - Medical Billing (Reimbursement Specialist). Position Highlights: Nebraska Medicine is now taking applications for a talented individual to join us as an Experienced Medication Access Coordinator in our Retail/Specialty Pharmacy department and will focus on medical billing.. The MAC will support the new home infusion location by completing prior authorizations, insurance appeals, and removing any medication access barriers for patients.. (Also known as: Medical Billing, Reimbursement Specialist, Pharmacy Advocate, Pharmacy Insurance Tech, Pharmacy Technician, Pharmacy Financial Counselor). Leading Health Network Work with the region's top academic health network, partnering with UNMC to transform lives through education, research, and patient care.
Foresight Diagnostics is an early-stage, venture-backed molecular diagnostics company that is developing non-invasive cancer detection technologies to improve the lives of patients worldwide.. Our portfolio of cell-free DNA based liquid biopsy tests are rooted in novel and proprietary methods developed at Stanford University.. We have deep expertise in molecular biology, bioinformatics, and Next Generation Sequencing (NGS), and maintain a dynamic, fast-paced work environment with significant opportunities for high-impact contribution and rapid professional growth.. Support medical device reporting, post-market surveillance, and vigilance reporting per the regulations.. Experience with next generation sequencing in vitro diagnostics in highly regulated environments (e.g., US FDA, CAP/CLIA, IVDD/IVDR).
This team includes a Psychiatric MD, a Primary Care Physician, a Psychologist, highly qualified Group Facilitators, and a dedicated Patient Navigator.. Minimum of 3 years of experience in medical billing and revenue cycle management, with a focus on mental health services or telehealth billing.. Proficiency in medical billing software and electronic health record (EHR) systems, with advanced knowledge of CPT, ICD-10, and HCPCS coding.. Knowledge of healthcare compliance regulations, including HIPAA, Medicare, and Medicaid billing requirements.. If you’re passionate about optimizing revenue cycle management and ensuring accurate and timely medical billing for virtual mental health services, we invite you to join our team at Sygnity Wellness.
We are seeking an experienced Business Analyst (BA) with expertise in Medical Billing and Coding, Java-based applications, SaaS platforms, and Agile methodologies.. Understand and document workflows related to medical billing and coding processes.. Ensure compliance with industry standards such as ICD-10, CPT, HCPCS, HIPAA, and Medicare/Medicaid guidelines.. Assist in optimizing revenue cycle management (RCM) through effective process documentation.. Strong knowledge of medical billing & coding (ICD-10, CPT, HCPCS, RCM, HIPAA).
Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders.. Reporting to the VP, Regulatory Affairs and Policy, this individual is responsible for leading and contributing to the preparation of CMC regulatory information packages for global submissions.. Line manage/mentor less experienced CMC regulatory team members as appropriate. Sr. Director Regulatory Affairs Early Development Lead Senior Director Regulatory Affairs, Sports Medicine & ENT Senior Director, Global Regulatory Affairs CMC, Cell Therapies Lexington, MA $208,200.00-$327,140.00 2 weeks ago. Director, Regulatory Affairs, Regulatory Science & Execution Associate Director, Global Regulatory Affairs Director Global Regulatory Affairs - Precision Medicine and Digital Health Boston, MA $174,500.00-$274,230.00 2 weeks ago
Associate Director, Regulatory Affairs Strategy. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.. Agios Pharmaceuticals is searching for a dynamic Associate Director, Regulatory Affairs Strategy to join our growing Regulatory team.. Associate Director: Must have minimum of 8 years pharmaceutical industry with 6 years in Regulatory affairs strategy. Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
CorDx a multi-national biotech organization focused on pushing the limits of innovation and supply in global health.. CorDx is at the cutting edge of technology, artificial intelligence, and data science with the goal of delivering diagnostic solutions to some of the most critical questions in healthcare.. Job Title: Regulatory Affairs Manager. 5-7 years of regulatory affairs experience within the medical device or IVD industry. Get notified about new Regulatory Affairs Manager jobs in San Diego, CA.
Our North American Commercial Operations, as well as our Headquarters and Technology Center for Hemostasis and Acute Care Diagnostics, are based in Bedford, MA. Our Headquarters and Technology Center for Autoimmunity Diagnostics is based in San Diego, CA. Additionally, our Technology Center for Hemostasis and Blood Gas Reagents is in Orangeburg, NY, and our Technology Center for Whole Blood Hemostasis is in San Diego, CA.. Provide guidance and regulatory input to various functional groups within the company to ensure optimal development of market access strategies.. Determine an event’s reportability to FDA under the Medical Device Reporting System (MDR), and to Competent Authorities for EU/EEA and Canada under Medical Device Vigilance System (MDV).. Must have experience in setting up/supporting multicenter medical device clinical trials, clinical FDA audits (BIMO), quality system development/implementation and both internal and 3rd party/FDA audits.. Emotional Intelligence Essentials Establishing and sustaining trusting relationships by accurately perceiving and interpreting own and others’ emotions and behavior; leveraging insights to effectively manage own responses so that one’s behavior matches one’s values and delivers intended results.
Key areas of focus include vendor management, cross-functional collaboration, and driving the in vivo and in vitro strategy across the pipeline.. Identify and implement preclinical models that reflect patient pathology; develop assays to support in vitro and in vivo assessments of efficacy or relevant biomarker activity.. Lead and oversee in vivo preclinical safety, PK/PD, and potential efficacy studies.. Define preliminary dosage and dosing regimens based on in vitro and in vivo data; partner with CMC and device teams to ensure feasible delivery approaches.. Ph. D. in Pharmacology, Pharmacokinetics, Biology, or related scientific fields.
Ambu A/S is currently looking for a Senior Regulatory Affairs Specialist to be based in Columbia, MD, US. As a Senior Regulatory Affairs Specialist, you will be responsible for enhancing our regulatory presence in the US and strengthening relationships with the FDA and other regulatory bodies.. FDA Intelligence : Stay informed by monitoring regulatory news and participating webinars, town halls, and conferences. Maintain contact with the FDA Ombudsman. Education: Bachelor’s or Master’s degree in Life Science, Pharmacy, Engineering, or a related field. Experience: Minimum 10 years of regulatory affairs experience in the US medical device industry, including direct FDA interactions
We build specialized, highly configurable, and integrated systems that support hospitals, blood centers, donation organizations, public health labs, and forensic labs.. InVita is a leader in the blood, implant, organ procurement, DNA, and Forensic software markets.. This is an ideal opportunity for someone who is not only fluent in regulatory requirements but is also ready to roll up their sleeves to get submissions over the finish line.. Exposure to QMS platforms and document control tools.. Reporting to : Chief Information Security Officer
Join to apply for the Regulatory Affairs Manager role at BioSpace.. Organize and track the internal review process of regulatory documents, including reconciliation of review comments, editing, formatting, version control, and finalization within the Veeva RIM Platform. Submit and distribute regulatory documents to Catalyst’s partners and the Pharmacovigilance group. Collaborate with Regulatory Operations to enhance regulatory submission and information management capabilities within the Veeva RIM platform. Solid understanding of Good Clinical Practice (GCP) and end-to-end regulatory submissions and archival processes