Collecting information
Organizing data
SUMMARY The Clinical Research Coordinator (CRC) is responsible for the coordination of daily clinical trial activities.. The CRC will assist the PI in protecting the rights, safety and welfare of all study participants.. Responsible for the preparation and ongoing maintenance of Essential Documents (The Trial Master File).. For example, but not limited to; (FDA Federal Code of Regulations Good Clinical Practice (GCP), Health Insurance Portability and Accountability Act (HIPPA), International Air and Transportation Association (IATA) - Shipping of Dangerous Goods.. Basic knowledge of FDA regulations, IRB requirements and Good Clinical Practice.
This position is ideal for a licensed pharmacist with strong attention to detail and an interest in clinical research.. Oversee IP preparation, sterile compounding, storage, and dispensing activities. Doctor of Pharmacy (PharmD) degree OR completing a program in less than 3 months. Flourish Research represents one of the industry's most progressive and diversified clinical trial companies with robust capabilities in the therapeutic areas of cardiology/metabolic disorders/renal, CNS, pulmonology, and vaccines.. In clinical trials and healthcare, excellence means everyone deserves the best care, regardless of their race, color, gender identity, religion, ethnicity, physical abilities, age, sexual orientation, or veteran status.
Seeking an innovative and experienced leader to join our dynamic team in Philadelphia as a Patient Care Manager.. Serve as a communication link between patients, families, and healthcare providers to ensure seamless care coordination.. Required Qualifications: Previous experience in home care setting with two years management or supervisory experience, preferred.. Knowledge of accepted professional standards and practice, Medicare Conditions of Participation, and federal, state, and local regulatory requirements Required Certifications and Licensures: Registered nurse with current licensure to practice nursing in the practicing state.. If you are passionate about leading a team to achieve excellence in home health care, we welcome your application.
Seeking an innovative and experienced leader to join our dynamic team in Philadelphia as a Patient Care Manager.. Serve as a communication link between patients, families, and healthcare providers to ensure seamless care coordination.. Required Qualifications: Previous experience in home care setting with two years management or supervisory experience, preferred.. Knowledge of accepted professional standards and practice, Medicare Conditions of Participation, and federal, state, and local regulatory requirements Required Certifications and Licensures: Registered nurse with current licensure to practice nursing in the practicing state.. If you are passionate about leading a team to achieve excellence in home health care, we welcome your application.
Under direction of a Research Clinical Trial Operations leader, the Lead Clinical Research Coordinator will independently coordinate and will be accountable for the overall administration and outcome of multiple clinical studies within the Clinical Trials Office, requiring advanced-level knowledge and skills, involving human subjects that are being conducted within the Nicklaus Children's Research Institute.. Oversees study conduct including all support data collection for study start-up activities.. Submits protocol amendments and other documents requiring IRB submission to the Research Regulatory Affairs team and notifies CTMS support staff for protocol digitization.. Compiles accurate CTMS metrics data for updating SAC CTO slides and runs weekly enrollment reports for management review.. Clinical research certification through SOCRA or ACRP (CCRC, CCRP, CRA) required within 1 year in position
MedInsight is a subsidiary of Milliman; a global, employee-owned consultancy providing actuarial consulting, retirement funding and healthcare financing, enterprise risk management and regulatory compliance, data analytics and business transformation as well as a range of other consulting and technology solutions.. As the Director, Government Programs - Medicare & Medicaid, you will lead the strategic expansion of MedInsight's footprint in the Medicare Advantage and Medicaid Managed Care sectors.. Serve as a thought leader on value-based care contracting, continuously assessing the evolving needs of government payers and adapting strategy accordingly.. Familiarity with Medicaid waiver programs, dual-eligible strategies, and state innovation models. Background in government affairs, regulatory strategy, or public health policy a plus
Mission: To reduce the state cancer burden for all Virginians by addressing the confluence between biological, social, and policy drivers through high-impact, cutting-edge research; person-centered care across the continuum, from prevention through survivorship; community integration; and training the next generation of community-centric researchers and healthcare professionals.. Vision: To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all.. A Clinical Research Nurse (CRN) supports Principal Investigators (PI) in the day-to-day activities required for activation, execution, and management of clinical research studies or protocols. Serve as a lead research coordinator for an emerging central coordinator pool, work with leadership to lay the groundwork for expanding a coordinator pool, and overall portfolio staffing and management;.. Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as well as any other mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training as required;
Vision: To be a premier community-focused cancer center leading the nation in cancer health equity research and ensuring optimal health outcomes for all.. Serve as a lead research coordinator for an emerging central coordinator pool, work with leadership to lay the groundwork for expanding a coordinator pool, and overall portfolio staffing and management;.. Maintain current CITI credentials for Human Subjects Protections, Good Clinical Practice (GCP), Clinical Research Coordinator, plus additional sponsor GCP certifications as well as any other mandatory competencies and certifications required by VCU and VCUHS, individual clinical trials and the NIH Human Subjects Protection training as required;.. 2+ years experience with various clinical research or healthcare technologies including but not limited to: EDC software, XML, OnCore, EMR (Cerner or EPIC), RedCap, DEEP6A;.. Please note that if you are employed as a university employee working in any of the health system's facilities, you will need to follow VCU Health System policies, which will include but will not be limited to, vaccination requirements.
Join our Legal team at Helen of Troy and make an immediate impact on our trusted brands: OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar , Curlsmith , Revlon and Olive & June. Together, we build innovative and useful products that elevate people's lives everywhere every day.. Ensure compliance with global regulatory requirements from agencies such as the FDA, Health Canada, and the European Union's MDR, as well as with standards from organizations like CPSC, FCC, and EPA where applicable.. Provide regulatory input for clinical evaluations, human factors studies, and post-market surveillance activities.. Advanced degree (MS, PhD, MBA, or RAC certification).. Founded in 1968, Helen of Troy is a prominent player in the global consumer products industry, offering diverse career opportunities across North America, South America, Europe, and Asia. We boast a collection of renowned brands such as OXO, Hydro Flask, Osprey, Honeywell, PUR, Braun, Vicks, Hot Tools, Drybar, Curlsmith, Revlon, and Olive & June – many of which rank #1, #2, or #3 in their respective categories, making the Helen of Troy name synonymous with excellence and ingenuity.
As the Public Policy Strategist, Clinical Trials, you will lead Veeva’s policy engagement with federal lawmakers, regulatory agencies, and key industry stakeholders from our Washington, D.C. office.. Minimum 3 years of experience in public policy, government affairs, or regulatory strategy related to life sciences or healthcare. Demonstrated ability in lobbying, legislative affairs, public policy, or government service (nonprofit, trade association, corporate, or public sector roles). Established network of government and/or industry contacts in clinical trials, regulatory, or digital health policy. Working knowledge of global data standards and interoperability frameworks relevant to clinical research (e.g., CDISC, USCDI, HL7 FHIR)
Job Title: Director, Regulatory Affairs Advertising & Promotion — Novartis.. Serves as a primary regulatory advertising and promotion reviewer for assigned products on Materials Approval Process (MAP) teams, including launch products/indications, or complex and/or high-priority products.. Collaborates with other Regulatory Affairs colleagues to provide input to study designs or US label regarding feasibility of promoting potential data/claims.. Advanced degree desirable (MS, PhD, PharmD, or JD). Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution
Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials.. Within the Regulatory Affairs Team, the Regulatory Affairs Manager will be responsible for the following, under the direction of Department Leadership.. The Regulatory Affairs Manager will oversee, and assist in the review of promotional materials to comply with regional regulatory requirements concerning advertising and promotion.. The Regulatory Affairs Manager will champion continuous improvement efforts and lead department initiatives.. Bachelor's degree in bioengineering/biomedical engineering,biochemistry, chemistry, molecular biology, or related technical science discipline required.
Position Overview The Quality Assurance Manager serves as a critical member of the multidisciplinary team, overseeing quality-related activities across healthcare communities.. The Quality Assurance Manager provides leadership, support, and direction while working collaboratively with community management and regional teams to develop and implement quality processes.. Monitor and analyze infection control data and vaccine compliance rates. Utilize Electronic Health Records (EHR) systems for quality monitoring and reporting. Current state license as a Registered Nurse (RN) or Licensed Practical Nurse (LPN)
The Director of Clinical Training and Quality Assurance is a Registered Nurse (RN) or a Qualified Therapist (Physical Therapist, Occupational Therapist, or Speech Therapist) licensed in the state of practice.. This individual is responsible for the professional development and clinical training of staff and the administration of the agency’s Performance Improvement (PI) and Quality Assurance (QA) program.. Participate in policy development and ensure regulatory compliance (Medicare, Medicaid, accrediting bodies, etc. Participate in community education, research, and special projects as assigned.. Assist in developing and implementing the agency’s emergency management and PI plans.
IDEAYA is a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer.. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease.. The Director of GCP QA is a leadership role responsible for overseeing the quality assurance activities related to Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP).. The candidate will represent QA and function as the GCP QA lead and accountable for Good Clinical Practice (GCP), Good Pharmacovigilance Practice (GVP), Good Clinical Laboratory Practice (GCLP) oversight for all Ideaya Bio. clinical studies.. Partner with clinical development, regulatory affairs, pharmacovigilance, and other functions to ensure alignment on quality and compliance objectives.
The scope includes enhancing growth accelerators within the current CAP and Respiratory Care business domains and diversifying into alternative therapies, adjacent sleep disorders, and beyond.. This role requires the ability to oversee a broad portfolio of products, including those that may not be medical devices in all markets, understanding the nuance of such differences and providing the business with actionable strategies to support growth.. Qualifications & Experience Bachelor’s degree in biomedical engineering, regulatory affairs, life sciences, or related discipline.. Prior experience working with ResMed-type devices (CPAP, ventilators, masks, accessories).. Hands-on experience with submission platforms and document control tools (e.g., RIMSYS, Jira, Confluence).
Novartis has an incredible opportunity for a talented individual to join our team as the Director, Regulatory Affairs Advertising & Promotion.. Advanced degree desirable (MS, PhD, PharmD, or JD). Novartis may change the published salary range based on company and market factors.. The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.. Clinical Trials, Cross-Functional Teams, Drug Development, Lifesciences, Negotiation Skills, People Management, Problem Solving Skills, Regulatory Compliance, Risk Management, Strategy Execution
The University of California, Los Angeles (UCLA) invites applications for the position of Associate Director of Clinical Theranostics Research at the Assistant or Associate Professor level within the Ahmanson Translational Theranostics Division, Department of Molecular and Medical Pharmacology.. Assume clinical responsibilities, including conventional nuclear medicine, PET/CT and therapeutic and theranostic nuclear medicine services.. Play an integral role in the dosimetry program, integrating personalized radiation dose estimation into clinical research protocols and patient care pathways,. Significant experience in clinical trials, preferably in the theranostic or molecular imaging space.. ACRP certification, expertise in regulatory affairs and regulatory submissions, IND filings, engagement with the FDA, IRB submissions, GCP, and CITI
Support healthcare professionals and investigators with publications and clinical trials related to Company products, collaborating with Global Medical, Clinical, & Regulatory Affairs. Evaluate proposals for Investigator Initiated Trials for potential sponsorship. Job Requirements Advanced degree in a clinical or scientific discipline (e.g., Ph. D., MD, PharmD, Nurse Practitioners, Physician Assistants, Registered Dieticians) with 5+ years of relevant experience. At least 1 year of experience as an MSL preferred. Knowledge of drug development, clinical trial design, US healthcare system, and regulatory standards.
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.. seeks to provide, in a synergistic fashion, excellence in education - training physicians, nurses and other health care professionals, as well as biomedical scientists - and cutting-edge interdisciplinary research collaboration, enhancing our basic science and translational biomedical research capacity in order to improve human health.. Emphasizing service, we are dedicated to the Catholic, Jesuit principle of cura personalis - "care of the whole person.". As an employee of Georgetown University, the Clinical Research Fellow directly supports the University's mission of Cura Personalis.. Experience with neuroimaging, neurophysiology, or biomarker research related to movement disorders