- Merck & Co. (North Wales, PA)
- …others to implement the regulatory strategy for the DHT/SaMD in global clinical trials . Finally, in the post-market commercial landscape, RDH works with ... regulatory capabilities of DHTs and SaMDs, identify regulatory risks and requirements. In the clinical ...Opportunities: This Fellowship will be geared towards a Sr. Specialist position and does not align to a full… more
- 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
- Merck & Co. (Rahway, NJ)
- …The Specialist will be responsible for: Authoring scientifically valid clinical trial registration and results postings on www.ClinicalTrials.gov (United ... Writing & Disclosure Department of the GCTO ( Global Clinical Trial Operations) organization prepares a variety... development portfolio and compliance in public disclosure of clinical trials and their results, document disclosure,… 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
- 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 (Paramus, 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 (Wilmington, 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
- 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
- Actalent (Basking Ridge, NJ)
- …and life-enhancing care! Apply Now for more info! Description: + Manages multiple clinical trials . + Oversees reports and assists with statistical analysis. + ... center members. + Builds research infrastructure to support multi-center clinical trials . + Performs project management for...experience in clinical research. + Experience in clinical protocol and trial document development. +… 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
- 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
- Rush University Medical Center (Chicago, IL)
- …activities. Responsible for managing, reconciling and invoicing all revenue secured by Clinical Trials Research Revenue Cycle, work closely with operations, ... requirements specific to Research Billing. * Maintain a detailed understanding of Medicare's Clinical Trial Policy (NCD 310.1) and related guidance documents. *… more
- Children's Hospital Boston (Boston, MA)
- …to coordinate and manage clinical research as a part of the Progeria Clinical Trials team at Boston Children's Hospital. The coordinator will interact with ... research subjects and families during complex clinical trial visits and work with our...knowledge of each study. + Maintaining and completing all regulatory documents that include: FDA annual reports, DSMB reports,… more
- Hackensack Meridian Health (Paramus, NJ)
- … Practice (GCP), and Institutional policies and procedures as it relates to all regulatory aspects of assigned clinical trials conduct. This role will ... for all regulatory matters concerning all assigned clinical trials and is responsible for the...clinical trial lifecycle for all assigned clinical trials . **Responsibilities** A day in the… more
- Johns Hopkins University (Baltimore, MD)
- …start-up process and minimize delays. Operational support related to OnCore (JHM Clinical Trial Management System), including the eReg platform, and managing ... Prepare accurate IRB submissions and obtain timely IRB approval. + Submit NDA, clinical trial agreement/contract, and budget approval for review and execution. +… more
