- Alaka'ina Foundation Family of Companies (Frederick, MD)
- Regulatory , Clinical , and Technical Clinical Trial support Location MD - Frederick Job Code 10393 # of openings 1 Apply Now ... has a potential need for top talent to provide Regulatory , Clinical , and Technical Clinical Trial support services to a DoD biomedical research program… more
- University of Washington (Seattle, WA)
- …with laboratory clients (physician and other medical providers) related to aspects of technical clinical development and regulatory questions or concerns. + ... Regulatory Development (Research Scientist/Engineer-Senior (ES 10)) will supervise technical development of clinical assays and optimization of… more
- Actalent (Maryland Heights, MO)
- …that may require concept building, Target Product Profile (TPP), claims definition, regulatory strategy (including non- clinical and clinical ), Non- ... Qualifications: Skills Needed for Day 1: o Responsible for regulatory review of clinical documentation o Authoring... documentation o Authoring summaries/having very good skills in technical review of clinical summaries o Knowing… more
- Dignity Health (Phoenix, AZ)
- …relevant communications to the physician-investigators and clinical research teams. Provides regulatory and technical guidance to the clinical program ... campus._ **Responsibilities** Manages the daily operation and supervision of the Clinical Research Regulatory Affairs area and program specialist(s) in… more
- Children's Hospital Boston (Boston, MA)
- 74351BRJob Posting Title:Safety & Quality Coordinator (Patient Safety/ Clinical Regulatory )Department:Program for Patient Safety and ... and Quality Coordinator - Patient Safety will support safety and regulatory system improvement projects and the safety event reporting system. They… more
- Universal Health Services (King Of Prussia, PA)
- …in development, establishing ownership and maintaining work teams. + Apply broad clinical informatics knowledge ( technical and process) with highly comprehensive ... Information Services Department is seeking a dynamic and talented Senior Clinical Informatics Specialist. The Senior Clinical Informatics Specialist provides… more
- St. Peters Health (Helena, MT)
- JOB SUMMARY (overview of job): The Technical Clinical Laboratory Supervisor oversees the activities of the clinical laboratory and ensures its smooth and ... efficient functioning. This position maintains technical area assigned to meet regulatory requirements,...experience, or both, in high complexity testing . The Technical Clinical Laboratory Supervisor is responsible for… more
- ThermoFisher Scientific (South San Francisco, CA)
- …the autonomy, resources and tools they need to take science a step beyond. The Technical Application Scientist - Clinical Sequencing is part of the Life Sciences ... support for Ion and Oncomine Assays. Collaborate on customer projects, providing technical expertise and clinical insights to enhance the implementation and… more
- Sutter Health (Davis, CA)
- …transfusion / blood bank as wel as other areas of the laboratory. Functions as the technical and clinical subject matter expert in one or more areas of the ... regulatory agency inspections. Advises on, and provides guidance for, technical and clinical problem-solving or trouble-shooting, ensuring accurate and… more
- Trinity Health (Maywood, IL)
- …happening at Loyola Medicine. New state of the art Regional Clinical Laboratory. The new lab enables greater operational efficiencies, improved turnaround ... HLA **Hours:** **Day shift: Monday-Friday** **8:00am -4:30pm** Brand NEW Clinical Laboratory - Features daylight access, in an open...lab space **About the Job** In this role, the Technical Specialist (HLA) will oversee the daily operation of… more
- Pfizer (Cambridge, MA)
- …strategies with global strategies + May provide indication-specific input for efficient clinical trial development and response to regulatory authorities + May ... events, including serious adverse events, and other safety **RESPONSIBILITIES** + Provides clinical expertise and technical excellence for asset development, … more
- Lilly (Indianapolis, IN)
- …Lilly in external forums where standards, common protocols, assessment instruments, regulatory standards and clinical guidelines concerning drug development ... study initiation and conduct (ie, ethical review board, informed consent, regulatory approval/notification) consistent with Good Clinical Practices (GCPs) and… more
- University of Colorado (Aurora, CO)
- …phone contacts and personal interviews. + Schedule subject participation in research clinical trial. + Adhere to research regulatory standards. + Maintain ... of the Food and Drug Administration (FDA), study protocols, department, hospital/ clinical standard operating procedures, and other regulatory guidelines. +… more
- Abbott (Manhattan, NY)
- …failure, attrition rate, etc. Monitors to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive ... key site personnel including the Principle Investigator, Research Coordinator, as well as regulatory and legal personnel. + Provide ongoing technical support to… more
- University of Colorado (Aurora, CO)
- …of the Food and Drug Administration (FDA), study protocols, department, hospital/ clinical standard operating procedures and other regulatory guidelines. + ... of the Food and Drug Administration (FDA), study protocols, department, hospital/ clinical standard operating procedures and other regulatory guidelines. +… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …and regulatory aspects of the products to provide medical, clinical and scientific support, mentoring and leadership across these areas. **RESPONSIBILITIES AND ... with the appropriate integration of safety and efficacy data from clinical studies longitudinally and cross-sectionally to support regulatory submissions,… more
- University of Colorado (Aurora, CO)
- …- Requisition: #** **33067** **Job Summary:** **Key Responsibilities:** + Performs clinical research coordination and regulatory processes, procedures as defined ... #00821011 - Requisition: #33067** **Job Summary:** **Key Responsibilities:** + Performs clinical research coordination and regulatory processes, procedures as… more
- Johns Hopkins University (Baltimore, MD)
- …Requires minimum of two years of management experience. + Requires experience in clinical research and regulatory affairs. + Experience in protocol and informed ... and/or clinical trials. + Requires experience in clinical research and regulatory affairs including FDA...clinical trials preferred. + Proficiency in writing SOPs, technical and programmatic reports. + Proficiency in the use… more
- Abbott (Atlanta, GA)
- …attrition rate, etc. and will monitor to ensure compliance with applicable regulatory requirements, Good Clinical Practice, and accuracy standards inclusive of ... key site personnel including the Principal Investigator, Research Coordinator, as well as regulatory and legal personnel. + Provide ongoing technical support to… more
- Edwards Lifesciences (Columbus, OH)
- …safety, in keeping with protocols, GCP (Good Clinical Practices) and regulatory requirements. + Develop and deliver technical training on GCPs, protocols, ... related field or equivalent + 5 years of medical device/sponsor/CRO/Pharma clinical field monitoring experience, quality assurance/control and regulatory … more