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As you shop, dine and Client a Great American Main Street, you will enjoy a rich variety of performing and visual arts, hiking, biking, camping, golfing and fishing.. The rolling hills and abundant farmland of the Frederick County countryside is where scenic byways lead to wineries, orchards, and Civil War heritage.. The Research Physician shall serve as a Principal Investigator or Clinical Research Physician and provide expertise in the areas of clinical research and regulatory affairs as they relate to clinical studies, healthcare management, and technology-based training and education programs.. Must have one of the following specialties: Board Certification in a Primary Care Specialty including Family Practice, Internal Medicine, Preventive Medicine, or Pediatrics with knowledge of adult medicine.. Shall be knowledgeable in the areas of clinical research and regulatory affairs as they relate to clinical studies, healthcare management, and technology-based training and education programs.
Community Outreach Develop and implement strategies to engage with the local community to raise awareness about clinical trials and Velocity Clinical Research. Collaborate with Patient Experience team to plan and facilitate community outreach events. Organize and participate in community events, workshops, and educational sessions to educate potential participants about the benefits and risks of clinical trials. Operational Execution Enact on centrally planned strategies/campaigns directed by the Recruitment Strategy Manager (RSM) or other Velocity operational leadership. 2+ years previous experience in clinical research, recruitment, or healthcare administration; or advanced healthcare degreee or certification.
The University of Maryland School of Medicine has exciting opportunity for Clinical Research Nurse to join the Division of Addictions Research and Treatment in the Department of Psychiatry.. The Clinical Research Nurse will assist in the administration of NIH-funded, multi-site clinical trials investigating interventions with patients engaged in outpatient and office-based addiction treatment programs.. The Clinical Research Nurse will work in collaboration with lead and local site investigators to implement protocols and carry out day to day study activities at University of Maryland addiction programs.. The Clinical Research Nurse will support division faculty initiatives and studies as assigned.. Other: May require training related to occupational safety and health, environmental compliance, shipping of hazardous materials and/or ionizing radiation May substitute additional years of relevant experience in lieu of minimum education.
The position will ensure that processes for the Quality Management System (QMS) are effectively established, implemented, and maintained while proactively improving processes to comply with regulatory standards, including 21 CFR Parts 820 (Medical Devices) and 1271 (Human Cells, Tissues, and Cellular and Tissue-Based Products). This position is based on-site at the company’s new Gaithersburg, MD facility. Oversee Quality Assurance functions related to Operations, Quality Systems, and Quality Engineering activities. Extensive experience in the healthcare industry (medical devices, pharmaceuticals) in both commercial and R&D/product development settings; combination product experience (device/drug) is a plus. ASQ Certified Quality Engineer (CQE) or ASQ Certified Quality Auditor (CQA) preferred.
We are seeking a Sr. Research Nurse who will provide research coordination support for complex early phase clinical trials conducted in the Drug Development Unit (DDU) in the Division of Clinical Pharmacology. The Sr. Research Nurse will collaborate with the study's clinical team and faculty to implement multiple research protocols and will oversee study related activities. Oversees and supports study visits for non-licensed DDU staff (e.g. study coordinator, clinical research fellow). At the direction of the Clinical Pharmacology faculty, assists in ordering research doses of radioisotopes from a commercial radiopharmacy. Assist in monitoring the data integrity of studies assigned to other research nurse coordinators using Quality Assurance forms maintained by the DDU.
DelRicht is a clinical research company dedicated to providing an excellent customer experience to all patients that participate in our clinical trials. Our clinical trials provide new treatment options for our patients and ultimately our goal is to get new medications and medical devices FDA approved!. Clinical Research Nurse’s Main Objective: Overall, the Clinical Research Nurse is responsible for providing quality, excellent patient care and a great experience for our patients in our clinical research studies. Required: Registered Nurse (R.N.) or Licensed Practical Nurse (L.P.N).. This is an onsite Monday-Friday position traveling between Vienna, VA and Rockville, MD. No remote or hybrid-seeking applicants, please.
Clinical Research Nurse. Research Nurse Specialist. The National Institute of Dental and Craniofacial Research (NIDCR) is seeking a dedicated Research Nurse Specialist to support our Clinical Research program.. We offer a variety of full-time, project (SOW), seasonal, and surge support opportunities in science, engineering, technology, professional, and administrative support roles.. It's the ripple effect that changes and improves everything for your family, your community, and the world.
Establishes and maintains the lifecycle of controlled documents, including but not limited to: records management system including version control, document distribution, archival, retrieval, retention and destruction. Bachelor in a Life Sciences discipline with 8 - 10 years of experience within the life sciences or similar industry, preferably biotechnology or pharmaceuticals, performing within a Quality Systems/Quality Assurance/Quality Control role with some or all of that time responsible for Document Control activities.. Masters' in a Life Sciences discipline with 6 - 8 years of experience within the life sciences or similar industry, preferably biotechnology or pharmaceuticals, performing within a Quality Systems/Quality Assurance/Quality Control role with some or all of that time responsible for Document Control activities.. Thorough knowledge of cGMP regulations, quality systems and regulatory requirements. 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.
Overview: The Senior Manager role, reporting to the Senior Director in Risk Adjustment and will manage 3-4 direct reports in the Medicare risk adjustment coding of medical records utilizing Epic EMR with application of RA standards.. This role will support development and maintenance of key risk adjustment policies and procedure (coding guidance, chart review, deletes, QA).. PowerPoint presentation and execution of various regulatory audits (RADV, HHS, OIG).. Collaborates across organizations to manage collection and analysis of data from multiple reporting systems, sources, and emerging industry trends to identify opportunities to improve risk and threat management.. Bachelors degree in Analysis, Research, Statistics, Health Care (e.g., Registered Nurse), Healthcare Administration, Health Care Management, Economics, Business, Homeland Security, or related field AND minimum six (6) years of experience in risk management, quality program, claims management, patient safety, or directly related field OR Minimum nine (9) years of experience in risk management, quality program, claims management, patient safety, or a directly related field.
The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.. Within Leidos Biomedical Research Inc. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum.. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations.. Provides inpatient and outpatient consultative Infectious Disease care for Hematopoietic Stem Cell Transplant (HSCT) Patients. Board certification in Internal Medicine and Allergy and Immunology or Infectious Diseases (other Internal Medicine specialty training will be considered)
The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.. Within Leidos Biomedical Research Inc. (operator of the Frederick National Laboratory for Cancer Research), the Clinical Research Directorate (CRD) provides clinical supervision of programs at the clinical end of the research spectrum.. CRD also provides operational support for clinical research and supports clinical trials management, regulation, pharmacovigilance, and protocol development/protocol navigations.. Provides inpatient and outpatient consultative Infectious Disease care for Hematopoietic Stem Cell Transplant (HSCT) Patients. Board certification in Internal Medicine and Allergy and Immunology or Infectious Diseases (other Internal Medicine specialty training will be considered)
The Frederick National Laboratory is operated by Leidos Biomedical Research, Inc. The lab addresses some of the most urgent and intractable problems in the biomedical sciences in cancer and AIDS, drug development and first-in-human clinical trials, applications of nanotechnology in medicine, and rapid response to emerging threats of infectious diseases.. The Vaccine, Immunity and Cancer Directorate (VICD) at the Frederick National Laboratory investigates immune responses to vaccines in preclinical and clinical studies.. To address gaps and unmet needs in serology assay development and standardization and to gain a solid fundamental knowledge of the immune response to underlying mechanisms of protection against infection, leveraging the vast expertise and excellence in HPV serology at the FNL. Experience in quality control and quality assurance related to immunology, virology and/or molecular biology procedures for reagent production and assay development and performance.. Experience working with standards and reference materials, immune assay (ELISA, multiplex assays) development and validation.
We are seeking a dedicated and dynamic Medicare Sales and Customer Service Manager to join our team. Medical, dental and vision packages, including an annual reimbursement for qualified wellness expenses, personal health coaching and telemedicine options.. Manages inbound calls and walk-in contacts with members, responsible parties, and providers/vendors for the Erickson Advantage Member Services; and Care Coordination Office at the Erickson community and documents all contacts in the CaseTrakker System.. Acts as a primary resource to health plan members in problem resolution collaborating with the United Healthcare Service Center and other United Healthcare points-of-contact as needed.. Arranges for order/delivery of medical equipment, supplies, and services as requested by the Community Care Coordinator or the Primary Care Physician
Foster close cooperative relationships with all functions in the company relative to regulatory compliance, including working with Product Development, Package Development, Legal, Quality Assurance and Marketing to execute all initiatives for assigned brands.. 6+ years of experience in U.S. and/or Canada pharmaceutical or medical device Regulatory Affairs. Significant experience with U.S. drug and/or medical device regulatory submissions and maintenance; OTC preferred.. Strong knowledge of OTC drug and device regulations, including labeling requirements. The Manager, Regulatory Affairs will provide support to Operations, Quality, Graphics,
As a technical expert in quality and compliance, the Senior Quality & Compliance Auditor plays a critical role in ensuring adherence to company policies, study protocols, GxP guidelines, and global regulatory requirements governing clinical research activities.. Lead and execute comprehensive quality and compliance audits in accordance with regulations and standards governing clinical research (including internal audit, vendor audit and site audit) to assess adherence to regulatory standards and company policies. Oversee and review corrective action/preventative action (CAPA) plans, ensuring timely implementation and effectiveness in addressing non-compliance issues. Develop and lead Alimentiv's auditor training program for Corporate Quality, ISO auditors and other Alimentiv staff by providing guidance on audit techniques, risk assessment and system approach. Certified Auditor (ASQ, ISO, or equivalent)
The role is positioned in the Clinical Pharmacology group, Clinical and Quantitative Pharmacology (CQP) function within Modernas growing Therapeutics & Oncology development organization in R&D. This role will closely partner with CQP colleagues in Pharmacometrics and Quantitative Systems Pharmacology to determine and implement the overall CQP strategies across therapeutic areas, from preclinical development through lifecycle management.. Success in this role requires close collaboration with the Translational Medicine, Research (including Nonclinical Development), Clinical Development, Clinical Safety and Risk Management, Biometrics, and Regulatory functions to ensure integrated and innovative clinical pharmacology strategies are developed and executed to enable agile development of our exciting pipeline.. PhD and/or PharmD in Clinical Pharmacology, Pharmacometrics, Pharmaceutics, Statistics, Engineering, or a related field with a minimum of 8-10 years of industry experience in clinical pharmacology. In depth knowledge of clinical pharmacology, PK/PD principles, modeling and simulation, ADME and quantitative translational sciences. A holistic approach to well-being, with access to fitness, mindfulness, and mental health support
The Vice President of Safety and Regulatory Affairs is a senior executive responsible for leading the hospitals enterprise-wide strategies in patient safety and regulatory compliance.. The VP of Safety and Regulatory Affairs also directs development and implementation of a system wide accreditation program to ensure continuous compliance with all federal and state regulatory standards (The Joint Commission, CMS, DPH, MA BORIM).. Serve as the primary liaison with legal counsel on claims, litigation, and potential liability exposure.. Masters degree in Healthcare Administration, Nursing, Risk Management, Public Health, or a related field.. Certified Professional in Healthcare Risk Management (CPHRM), Certified Professional in Patient Safety (CPPS), or related credential.
Play a major role in helping patients get involved in clinical trials.. They focus on diversity in their trials including therapeutic areas: cardiology, metabolic disorders, renal, CNS, pulmonology, and vaccines. The Clinical Research Assistant will focus on Patient Engagement and Enrollment as well as assistant for the clinical trial process. Community engagement and outreach events.. Healthcare experience (work or academic experience); Clinical Research exp preferred
From clinical trials to regulatory, consulting, and market access, every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.. At Parexel Baltimore Unit (located in the MedStar Harbor hospital) our highly trained and skilled Nurse Practitioner (NP)functions under the direction and guidance of a licensed physician to ensure the safety of study participants.. Your time here: As a Nurse Practitioner , you take the lead on study participant safety and are involved in all aspects of the trial development process at the Unit. You work as part of a team and will collaborate with other departments such as Nursing, Pharmacy, Screening, Laboratory, Clinical, Recruitment, and Project Management.. Executes and coordinates a variety of specialized clinical research activities ensuring compliance with GCP. Supports Standard Operating Procedures (SOPs), Good Clinical Practices (GCP), and all work processes to ensure the efficient and compliant clinical operation.
Leads and supports development and execution of corporate and portfolio growth strategy and provides thought leadership in achieving the mission and vision of the organization.. 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).. Must have a bachelors degree in business, project management, healthcare informatics, or related field