- University of Colorado (Aurora, CO)
- …**University of Colorado Anschutz Medical Campus** **Department: Colorado Multiple Institutional Review Board (COMIRB)** **Job Title: IRB Review ... ** IRB Review Specialist ** **Description**...of 1 days per week on campus The Colorado Multiple Institutional Review Board (COMIRB) exists to … more
- University of Maryland, Baltimore (Baltimore, MD)
- …position significantly contributes to the conduct of research. * Coordinates the preparation of Institutional Review Board ( IRB ) and Health Insurance ... them through procedures and visits required by the research protocol . The Bone Marrow Research Specialist is...Serves as a liaison to other departments such as IRB or CCT, outside organizations, government agencies, and product… more
- University of Maryland, Baltimore (Baltimore, MD)
- …collection and clarification, and general administrative duties. * Assists in the preparation of Institutional Review Board ( IRB ) and Health Insurance ... them through procedures and visits required by the research protocol . The Bone Marrow Clinical Research Senior Assistant/ Specialist...the conduct of research. * Coordinates the preparation of Institutional Review Board ( IRB… more
- Northwell Health (Lake Success, NY)
- …adherence to established protocols to ensure projects are carried out as directed by the Institutional Review Board ( IRB ). Works within scope of practice ... Drug Administration (FDA), Good Clinical Practice, institutional policies, sponsor requirements, Institutional Review Board ( IRB ) and related… more
- AdventHealth (Orlando, FL)
- …setting, with at least 2 years in a clinical research setting including an institutional review board office, research administration, or regulatory affairs ... Specialist II functions as a liaison between the IRB of record for each study protocol ,...review , approval, and clearance activities for each research protocol maintaining detailed, complete, accurate and current records at… more
- Houston Methodist (Houston, TX)
- …laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board ( IRB ), Food and Drug ... forms and associated documentation + Serves as a liaison between the institutional review committees, regulatory agencies, and the investigators to ensure… more
- University of Southern California (Los Angeles, CA)
- …Submits protocols and supporting documents to internal and external regulatory bodies (ie Institutional Review Board ), ensuring trials are consistent with ... and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for… more
- Actalent (Hackensack, NJ)
- …serve as a liaison to investigators, collaborating divisions, departments, and institutions, the Institutional Review Board ( IRB ), and external ... Job Title: Regulatory Specialist Job Description The Regulatory Specialist ...Serious Adverse Event (SAE) and IND safety reports. - Review and interpret IRB correspondence with the… more
- Actalent (Hackensack, NJ)
- …serve as a liaison to investigators, collaborating divisions, departments and institutions, the Institutional Review Board ( IRB ), and external regulatory ... Job Title: Regulatory Specialist Job Description The Regulatory Specialist ...Serious Adverse Event (SAE) and IND safety reports. + Review and interpret IRB correspondence with the… more
- Magellan Health Services (Falls Church, VA)
- …subject matter expert to Institutional Officials, Human Research Protections Officers (HRPOs), Institutional Review Board ( IRB ) members and staff, ... will assist with oversight of human research protection programs, Institutional Review Boards (IRBs), human subject protection...a final Assessment report or summary. + Headquarters Level Review of IRB reviewed protocols for which… more
- Weill Cornell Medical College (New York, NY)
- …and submits all necessary documents to the Clinical Science Evaluation Committee (CSEC), the Institutional Review Board ( IRB ) and ancillary committees. + ... Title: Regulatory Specialist Location: Upper East Side Org Unit: Geriatrics...+ Reports all Serious Adverse Events (SAEs) to the Institutional Review Board and other… more
- Cedars-Sinai (Los Angeles, CA)
- …federal and local agencies including the Food and Drug Administration (FDA) and local Institutional Review Board ( IRB ). Primary Duties and ... known nationally for excellence in research!** The Clinical Research Specialist I provides clinical research expertise by participating in...including the Food and Drug Administration (FDA) and local Institutional Review Board . + Maintains… more
- Dignity Health (Phoenix, AZ)
- …Administration (FDA) Office for Human Research Protections (OHRP) Good Clinical Practices (GCP) Institutional Review Board ( IRB ) HIPAA regulations and ... limited to the following duties: + Knowledge of regulatory requirements and institutional requirements when conducting study protocol (s). + Assists with… more
- University of Pennsylvania (Philadelphia, PA)
- …B will assist the regulatory specialist in preparing for all local and Central Institutional Review Board ( IRB ) documentation through the IRB , ... Williams Syndrome. Clinical Research Coordinator work includes study design, protocol development, submission to review boards, subject...specialist in preparing for all local and Central Institutional Review Board ( IRB… more
- Methodist Health System (Dallas, TX)
- …the IRB . * Create and/or adapt clinical trial informed consent documents for Institutional Review Board ( IRB ) submission. * Maintain regulatory ... Shift :** **Job Description :** Your Job: The Regulatory Specialist will perform expertise in the regulatory component of...events in accordance with Food and Drug Administration, sponsor protocol , and IRB regulations and guidelines. *… more
- Hackensack Meridian Health (Paramus, NJ)
- …and external investigators, sponsors, collaborating divisions, departments and institutions, and Institutional Review Boards (IRBs), Data Safety and Monitoring ... for a clinical trial in order to initiate a review in tandem with IRB review...documents pertaining to the DSMB, Biosafety Committee, and the Protocol Review Committee, when applicable. + Arranges… more
- Pennsylvania State University (University Park, PA)
- …In this dynamic position, the successful candidate will monitor and audit IRB protocol compliance, assist with the management of ClinicalTrials.gov accounts, ... and state regulations, track audit outcomes, and handle self-assessment audits to ensure IRB protocol adherence. + FDA QA Support: Offer support for… more
- Dana-Farber Cancer Institute (Boston, MA)
- …and review of select protocol and monitoring processes prior to IRB review . The Regulatory Affairs Specialist (RAS) positions are critical to ... The Regulatory Affairs Specialist (RAS) positions provides advanced expertise and regulatory... protocol documents in order to ensure timely scientific/ IRB review and approval. + Evaluates research… more
- Highmark Health (Pittsburgh, PA)
- …RESPONSIBILITIES:** + Manages work flow processes and conducts activities pertaining to IRB review and approval for protocols involving human subjects submitted ... OVERVIEW:** Ensures compliance with federal regulations, state laws and institutional guidelines throughout the review and approval...by researchers; monitors the protocol review process to ensure complete and… more
- University of Michigan (Ann Arbor, MI)
- …with grants administrators as necessary on purchases, effort allocations, etc. + Assist with Institutional Review Board ( IRB ) procedures such as ... responsibilities and meet deadlines + Understanding of basic medical terminology + Experience with Institutional Review Board ( IRB ) and other regulatory… more