- Merck & Co. (Rahway, NJ)
- …pharmacokinetic, exposure-response, quantitative system pharmacology, and other model-based analyses.-Perform clinical trial simulations to inform dose selection ... the-Quantitative Pharmacology and Pharmacometrics --Immune/Oncology-(QP2-IO)-team in the role of-Senior Specialist .--QP2-IO team is part of the Global Clinical … more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …inspection/release of materials related to manufacturing of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP ... of multiple myeloma. Legend Biotech is seeking a QA Warehouse Incoming Raw Material Specialist as part of the Quality team based in Raritan, NJ. Role Overview The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Federal regulations and company SOPs regarding safety reporting from both post-marketing and clinical trial sources for all Novo Nordisk Inc (NNI) US marketed ... About the Department The Clinical Development, Medical and Regulatory (CMR)...of individual case safety reports from both post-marketing and clinical trial sources to the FDA Assist… more
- University of Pennsylvania (Philadelphia, PA)
- …including but not limited to Phase I-IV clinical trials . The Clinical Research Regulatory Specialist C will, independently prepare and process all ... programs and resources, and much more. Posted Job Title Clinical Research Regulatory Specialist C...but not limited to Phase I-IV clinical trials . + Independently prepare and process all regulatory… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …treatments, prevention, community-based research, and laboratory-based translational human immunology. The Clinical Trials Regulatory Specialist I ... an entry-level position supporting regulatory affairs in clinical trial research. The primary focus of...small trial portfolio. KEY RESPONSIBILITIES: + Assists regulatory team ( Regulatory Specialist II… more
- Stanford University (Stanford, CA)
- Clinical Trials Regulatory Specialist 2 **School of Medicine, Stanford, California, United States** Research Post Date Feb 16, 2024 Requisition # 100464 ... innovative clinical research to improve human health. SCCR seeks a mission-driven Clinical Trials Regulatory Specialist 2. You will work with a… more
- Methodist Health System (Dallas, TX)
- … clinical , investigator initiated trials (IITs), and retrospective analysis of clinical data. The Regulatory Specialist will support the mission, ... requirements * Obtain and facilitate tracking of relevant regulatory documents for clinical trials ...trials assigned. * Assist in the development of clinical trial documents for signature of principal… more
- University of Pennsylvania (Philadelphia, PA)
- …Title Veeva Quality Assurance Specialist (Abramson Cancer Center) Job Profile Title Clinical Research Regulatory Specialist B Job Description Summary The ... is a world leader in developing and conducting innovative clinical trials for the prevention, diagnosis, and...CRU Regulatory Affairs Office seeks a full-time Regulatory Affairs Veeva Quality Assurance Specialist to… more
- Houston Methodist (Houston, TX)
- …event reports, safety reports, and notifies IRB of study closures. + Maintains the required regulatory files for all clinical trials to ensure regulatory ... and study specific protocols/plans and processes. The Regulatory Compliance Specialist position maintains documentation for clinical research studies, case… more
- Hackensack Meridian Health (Nutley, NJ)
- …Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the field ... for coordinating and overseeing clinical operations of all assigned clinical trials and participates in assessing, planning, implementing and compliant… more
- Vitalief (New Brunswick, NJ)
- …activation; regulatory compliance, data management. and other clinical trial activities for solid tumor, high enrollment, ... Join us and help clients adapt to evolving requirements in the research and clinical trial industry with cutting-edge solutions. Reasons to Work for Vitalief: +… more
- ThermoFisher Scientific (Greenville, NC)
- …a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of ... research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver... clinical research services provide end-to-end support for clinical trials from study start up to… more
- University of Colorado (Aurora, CO)
- …Team (CReST) has an opening for a full-time Clinical Research Startup Specialist to provide regulatory and operationalization startup support for a variety ... communicates with these entities in order to operationalize complex clinical trials . + Develops standard operating procedures... Clinical Practice, applicable regulations, and of the clinical trial lifecycle is essential. We are… more
- UCLA Health (Santa Monica, CA)
- Description The Division of Hematology-Oncology is seeking an experienced Senior Clinical Trial Specialist to join our team. In this role you will be ... the liaison for the site management and monitoring of clinical trials in Santa Monica. Responsible for...conduct Site Initiation Visits and Interim Monitoring Visits with clinical trial sponsor representatives; you will also… more
- University of Pennsylvania (Philadelphia, PA)
- …Prepare any necessary regulatory documentation DUTIES: The Clinical Trials , Billing, Budget and Compliance Specialist will report directly to the ... and much more. Posted Job Title Clinical Trials , Billing, Budget and Compliance Specialist Job Profile Title Financial Analyst Job Description Summary Job… more
- Houston Methodist (Houston, TX)
- …accurate data collection, documentation organization, and safety of study volunteers. Ensures accurate regulatory filing + Assists Clinical Trial Manager in ... is responsible for supporting multiple projects under supervision of Clinical Trial Manager which may include ...from conceptual bench research, to prototyping and development, to clinical trials and FDA approval. The Research… more
- MD Anderson Cancer Center (Houston, TX)
- …students, trainees, professionals, employees and the public. The primary purpose of the Clinical Trial Safety Specialist is overall analysis of safety ... safety and efficacy report data from MD Anderson sponsored trials using clinical and research expertise; ensure... clinical experience to include two years of clinical research. One year clinical trial… more
- Rush University Medical Center (Chicago, IL)
- …and accurate coverage analyses with budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents in order to ... PM) **Summary:** This position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist research staff within the… more
- Rush University Medical Center (Chicago, IL)
- …and accurate coverage analyses with budget overlay in a timely manner. * Review clinical trial protocols and related regulatory documents to prepare a ... - 4:30:00 PM) **Summary:** Reporting to the Director/Manager of Clinical Trials Research Revenue Cycle, this position...position will create coverage analyses in accordance with Medicare's Clinical Trial Policy (NCD 310.1) and assist… more
- Rockefeller University (New York, NY)
- …see the hospital website at: http://www.rucares.org/ Overview The Clinical Research Specialist serves as a regulatory expert and resource for investigators ... and new investigator audits, tracks deviations for early intervention, and supports clinical trial registration in Good Clinical Practice (GCP)… more