- UTMB Health (Galveston, TX)
- Clinical Study Monitor ( IRB ) - Provost...clinical research studies approved by UTMB Institutional Review Board ( IRB ). ... the research community. + Establish a monitoring plan for IRB -approved studies including UTMB investigator-initiated projects. +...findings from monitoring visits. + Asses the conduct of clinical studies by monitoring compliance with the… more
- Trinity Health (Ann Arbor, MI)
- …time **Shift:** Day Shift **Description:** As part of the Research Compliance Department, the Institutional Review Board ( IRB ) Administrator will join a ... policies and procedures. + Provides education and guidance to IRB members to assure that the board ...to meet or exceed regulatory requirements. Responsible for evaluating clinical studies and associated study … more
- Stanford University (Stanford, CA)
- …applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions ... handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify...protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies .… more
- Stanford University (Stanford, CA)
- …applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, ... handling research administration activities associated with the conducting of clinical trials. Monitor staffing levels and identify...protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies .… more
- Stanford University (Stanford, CA)
- …applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, ... Panel. + Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies . Complete annual reports to … more
- Emory Healthcare/Emory University (Atlanta, GA)
- …+ Performs related approved responsibilities as required. JOB SPECIFIC DUTIES: 1. Study Coordination: Oversee the day-to-day operations of clinical research ... up-to-date and complete throughout the course of the research projects. 5. Clinical Monitoring: Monitor participants' progress throughout the trials, and… more
- Stanford University (Stanford, CA)
- …or governing bodies, which include HIPAA and FDA regulations, Institutional Review Board requirements, and Good Clinical Practices. + Knowledge ... for staff handling research administration activities associated with the conducting of clinical trials. + Monitor staffing levels and identify adequate coverage… more
- Touro University (Hawthorne, NY)
- … team. + Ensure compliance with the Good Clinical Practice guidelines in clinical research. + Monitor study patients for adverse events in collaboration ... institutional protocols. + Screen and enroll patients onto clinical trials in collaboration with clinical team,...mail, phone, fax, e-mail for COG, sponsored, local and multi- institutional studies . Act as liaison between NYMC… more
- Bristol Myers Squibb (Summit, NJ)
- …site and CRA training materials and present these at SIVs and Investigator meetings + Review clinical narratives + Monitor clinical data for specific ... Scientist role is essential for providing scientific expertise to design and deliver clinical studies and programs. This position involves leading and executing … more
- System One (Pittsburgh, PA)
- …for the Billing Compliance and Financial Support Unit within the office. Responsibilities: + Review clinical trial submissions from study team into central ... system. + Maintain spreadsheets and systems designed to track study information. + Review IRB ...studies have entered OCT workflow per policy. + Monitor clinical research invoicing mailbox and route… more
- MD Anderson Cancer Center (Houston, TX)
- …or SOP) related to staff development and clinical trial regulation. Monitor adherence to department SOP and institutional policies. Communicates updates and ... protocols. Evaluate and resolve start up logistics with the study team and the Clinical Research Group...Group (CRG) Managers. * Faciltiation of applicable local, federal, institutional , and sponsor clinical trial process over… more
- Mount Sinai Health System (New York, NY)
- …events to institutional offices and committees (ie Data safety monitoring, institutional review board , etc.) + Facilitates in/external monitoring and ... events (ie serial vitals) and the accurate capture of clinical data for the purposes of the study...analysis of clinical program activity data. + Monitor clinical trial portfolio and enrollments to… more
- National Institutes of Health (Montgomery County, MD)
- …research including both exempt human subjects research and human subjects research that requires IRB review . Serve as the primary contact regarding IRB ... serves as the NIH Human Research Protection Program (HRPP) Institutional Official (IO). Responsibilities As an IRB ...as the responsible point of contact in regard to review of all research activities that are considered human… more
- University of Colorado (Aurora, CO)
- …and oversee the day to day operations of clinical trials and studies + Obtain study subject's medical history and current medication information, reviews ... not move beyond this level.** This position will coordinate clinical research studies for the Depression and... study progress summaries for sponsors, independent site monitor for clinical trials, and independent monitoring… more
- GAP Solutions Inc (Baltimore, MD)
- …marginalized communities. + In depth knowledge of Institutional Review Board ( IRB ) regulations and Good Clinical Practice (GCP) guidelines - ... and update files of all applicable regulatory documentation for Institutional Review Board ( IRB...practices. 4 + Assist staff on all facets of clinical studies including subject enrollment, scheduling outpatient… more
- Vitalief (Newark, NJ)
- …this resource will perform various research operations for specific assigned observational clinical studies (meaning patients are NOT being treated in a ... of standard operating procedures and manuals of operations for clinical studies . + Assist with the instructing...study patient consent forms & applications to the IRB . Responsible for reporting protocol changes to the … more
- Actalent (San Diego, CA)
- …staff in executing the clinical programs. Responsibilities + Serve as a Study Medical Monitor , authoring clinical trial documents including protocols, ... external partners and stakeholders, including clinical investigators, study coordinators/CRAs, and KOLs. + Review and...Essential Skills + Medical Degree (MD or DO) preferably board certified in medical oncology. + 5+ years' experience… more
- Pfizer (Pearl River, NY)
- …appropriate SOPs and the "Safety Data Review Guide - for Clinicians." + Monitor study safety issues and provide input to serious adverse events (SAEs) ... study team** + With supervision of medical monitor (director/Sr director) provides clinical input to...patient population, adequacy of clinical assessments as study is ongoing. + Contributes to medical review… more
- Stanford University (Stanford, CA)
- …applicable regulations; provide leadership in identifying and implementing corrective actions/processes. Monitor Institutional Review Board submissions, ... or governing bodies, which include HIPAA and FDA regulations, + Institutional Review Board requirements, and Good Clinical Practices. + Knowledge of… more
- University of Rochester (Rochester, NY)
- …in developing and overseeing the "on call" system for research staff to cover all active clinical studies + Monitor and track achievements of clinical ... & maintain the day-to-day operational duties of their assigned clinical trials and clinical research study...Obtain fully informed consent of all eligible trial & study patients in accordance to IRB , local… more