- Saint Louis University (St. Louis, MO)
- …liaison between the SLU SOM, clinical partners (eg, SSM Health), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good ... in a variety of studies; develops and submits documentation and information for Institutional Review Board (IRB) review ; communicates with the IRB staff… more
- Saint Louis University (St. Louis, MO)
- …liaison between the SLU SOM, clinical partners (ex. SSM Health), the Principal Investigator, Institutional Review Board (IRB), and sponsors to ensure good ... (GCP) throughout the life cycle of the study. PRIMARY JOB RESPONSIBILITIES Review and abstract medical record information and ensure proper adherence to… more
- Planned Parenthood (Minneapolis, MN)
- …of the Research Manager. This position will focus on research study start-up, Institutional Review Board (IRB) submissions, study project coordination ... Day-to-Day Responsibilities: Study Coordination and Reporting Independently develop and prepare Institutional Review Board applications, including completion… more
- University of Iowa Hospitals & Clinics (Iowa City, IA)
- …of the appropriate Human Subjects Review forms and application materials to the Institutional Review Board (IRB-01) as well as external IRBs such as ... authorities, and investigators and study coordinators. Coordinate external and internal review processes. Prepare and submit pre site selection visit documents.… more
- Cedars Sinai (Beverly Hills, CA)
- …all federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board (IRB). What are the Primary Duties and ... conduct. Works closely with a regulatory coordinator or directly with the Institutional Review Board (IRB) to submit Adverse Events, Serious Adverse Events,… more
- Virginia Commonwealth University (Richmond, VA)
- …student research activities including funding and presentation opportunities. Assist students with Institutional Review Board (IRB) processes, including the ... Research Day or student research symposia. Familiarity with research compliance and institutional processes related to IRB review , responsible conduct of… more
- Henry Ford Health System (Detroit, MI)
- …objectives of the established research protocol are met and in compliance with the Institutional Review Board (IRB) and sponsor guidelines. Identifies and ... recruits' patients into study protocols and provides ongoing education and emotional support to patients. Demonstrates clinical competence. Reports to Principal Investigator/Administrative Leadership. EDUCATION/EXPERIENCE REQUIRED: Graduate from a school of… more
- BayCare Health System (Tampa, FL)
- …with the standards of good clinical practice, federal and state regulations and institutional review board (IRB) requirements Ensures adherence to the ... study protocol and schedule of events Patient visit scheduling for protocol related procedures Screening, study recruitment, preparation of IRB reports Establishment and maintenance of regulatory documents Performing the process of informed consent and HIPPA… more
- Kaiser Permanente (Oakland, CA)
- …including those related to human subjects' research, research privacy, data management, Institutional Review Board (IRB) practices, and export controls. ... The manager will oversee compliance with regulatory requirements and liaise with regulatory agencies and bodies such as the Office for Human Research Protections (OHRP), Office of Research Integrity (ORI), and Food and Drug Administration (FDA). They will… more
- Stony Brook Medicine (Stony Brook, NY)
- …Investigational New Drug (IND) and Investigational Device Exemption (IDE) applications. Creating Institutional Review Board (IRB) submissions and managing ... or for a maximum of 90 days. An initial review of all applicants will occur two weeks from...means that when the Hospital is faced with an institutional emergency, employees in such positions may be required… more
- Nuvance Health (Norwalk, CT)
- …protocol implementation, data collection and query resolution, and submission to the Institutional Review Board (IRB). Coordinates studies in Oncology ... all study protocols, consent forms, and other required documents to the Institutional Review Board (IRB). 7. Educates hospital staff about protocols through… more
- Children's National Hospital (Washington, DC)
- …the development of action plans to improve quality. Facilitates the preparation of Institutional Review Board applications for research proposals, develops ... manage research and/or research intervention projects within the federal and institutional regulations and policies under the direction of the principal… more
- Northwestern University (Chicago, IL)
- …state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code ... of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Project Description: This position will be focused on a new research study, Healthy Moms/Mamis Saludables: Partnership to Prevent Maternal Diabetes in US Home Visiting… more
- The University of Pennsylvania (Philadelphia, PA)
- …duties and responsibilities as assigned Regulatory Responsibilities: Prepare and process all Institutional Review Board (IRB) documentation through the IRB, ... Initiation meetings Obtain slides from pathology and ship to sponsor/independent review per protocol guidelines. Obtain records required to complete case report… more
- Northwestern University (Chicago, IL)
- …state, & federal laws, regulations, guidance, policy & procedure developed by the NU Institutional Review Board (IRB), Food & Drug Administration (FDA) Code ... of Federal Regulations (CFR), & the International Conference on Harmonization (ICH). Please note: Supervisor provides objectives, deadlines and specific instructions only for new, difficult, and/or unusual work. Work is reviewed upon completion and only… more
- University of Massachusetts Medical School (Worcester, MA)
- …related supplies Participate in grant preparation, manuscript writing, data presentations and Institutional Review Board (IRB) processes Provide detailed ... of grant and contracts. May be responsible for clinical research billing review within the required timeframe. Track and maintain study related information in… more
- The University of Pennsylvania (Philadelphia, PA)
- …samples and related study documents, and collection of clinical data. Assist with Institutional Review Board (IRB) filings and inquiries, and assist ... required for IRB submission/renewals in accordance with guidelines; continuing review , modification, deviation, adverse events, etc. Conduction of intermittent… more
- UC Davis Health (Sacramento, CA)
- …including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), ... information in the clinical trial management system (OnCore) and adhere to institutional policies and external Cancer Center Support Grant guidelines for reporting… more
- Kaiser Permanente (Oakland, CA)
- …including those related to human subjects' research, research privacy, data management, Institutional Review Board (IRB) practices, and export controls. ... Integrity (ORI), and Food and Drug Administration (FDA). Demonstrated experience with Institutional Review Board (IRB) practices. Primary Location:… more
- Mount Sinai Hospital (New York, NY)
- …grant applications and documents and assists in protocol submissions (for eg, Institutional Review Board , Grants and Contracts Office). Responsibilities ... 1. Analyzes moderately complex clinical research data; Assists in interpreting clinical research data. 2. Coordinates the clinical assessments of the study subjects including but not limited to screening and evaluation of the study subjects. 3. Prepares and… more
