- Beckman Coulter Diagnostics (Miami, FL)
- …who possess various levels of clinical research experience.Ability to independently complete IRB submissions (initial review , change in research, continuing ... a part of the CCIA Clinical Affairs Team and report to the Clinical Affairs Manager responsible for planning and executing IVD clinical trials. If you thrive in a… more
- Dartmouth Health (Lebanon, NH)
- …Provides regulatory expertise, guidance and administrative support to the Dartmouth-Hitchcock (D-H) Institutional Review Board (s) ( IRB ). Responsible for ... concern to the HRPP Director or IRB Manager as appropriate. * Conducts non-committee review ...on applicable regulations, and subsequent submission in the electronic IRB protocol system. * Maintains D-H Collaborative Institutional… more
- Stanford University (Stanford, CA)
- …and relevant experience. **In addition, our preferred requirements include** : + Institutional Review Board professional certification desirable. **PHYSICAL ... IRB Manager **Dean of Research, Stanford,... IRB Manager **Dean of Research, Stanford, California, United States**...are seeking a candidate experienced with regulatory compliance and institutional review boards (IRBs) and that has… more
- Stanford University (Stanford, CA)
- …by Human Subjects Panel. + Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. + Complete annual ... Lead Program Manager (2-Year Fixed-Term) **School of Medicine, Stanford, California, United...reports to Institutional Review Board , CSTA, FDA and… more
- AdventHealth (Orlando, FL)
- …Specialist I, provides regulatory support to the research team by handling all of the Institutional Review Board ( IRB ) and regulatory submissions and ... Regulatory Specialist I, functions as a liaison between the IRB of record for each study protocol and the...experience in healthcare, clinical research or scientific setting, an institutional review board office, or… more
- University of Pennsylvania (Philadelphia, PA)
- …biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop...AEs, SAEs, and UADEs reports to the Investigator and Institutional Review Board ( IRB… more
- Johns Hopkins University (Baltimore, MD)
- …through recruiting and enrolling eligible patients into studies. + Prepare relevant documents for Institutional Review Board and as well for EPIC tracking. + ... maintaining institutional and federal regulatory compliance, including preparing the IRB initial application, annual IRB continuing reviews, changes in… more
- Rush University Medical Center (Chicago, IL)
- …Pediatrics, and liaisons with the Principal Investigators (PIs), Industry Sponsors, the Rush Institutional Review Board ( IRB ), Corporate Compliance and ... of each case. **Summary:** The Clinical Research Regulatory Compliance Manager serves as the subject matter expert for a...staff; registers for trainings (EPIC, CITI, ONCORE, Rush Internal Review Board ( IRB ) portal, Rush… more
- Stanford University (Stanford, CA)
- …Human Subjects Panel. + Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual ... Clinical Research Manager **School of Medicine, Stanford, California, United States**...reports to Institutional Review Board , CSTA, FDA and other regulatory… more
- University of Miami (Miami, FL)
- …limited to: Prepare and coordinate the entire process of regulatory document submission to the Institutional Review Board ( IRB ) from study start-up to ... faculty or staff position using the Career worklet, please review this tip sheet (https://my.it.miami.edu/wda/erpsec/tipsheets/ER\_eRecruiting\_ApplyforaJob.pdf) . The University of… more
- Houston Methodist (Houston, TX)
- …laws, regulations, guidance, policy and procedure developed by Houston Methodist Research Institute Institutional Review Board ( IRB ), Food and Drug ... and performing study specific regulatory processes such as local IRB and external IRB submissions in compliance...study personnel. + Acts as a liaison between the institutional review committees, regulatory agencies, and the… more
- Dialysis Clinic, Inc. (Decatur, AL)
- …and post-study closure. They prepare documentation for submission for review by the Institutional Review Board ( IRB ), recruit and screen study ... including the collection, preparation, maintenance, and submission of numerous study documents: Institutional Review Board ( IRB ) applications, CV's,… 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 Pennsylvania (Philadelphia, PA)
- …data entry. Independently manage different phases of clinical trials. They may assist with Institutional Review Board ( IRB ) filings, sponsor and ... They will work closely with the Principal Investigator, research manager , and study team to identify problems and develop...different phases of clinical trials. They may assist with Institutional Review Board ( IRB… more
- AdventHealth (Orlando, FL)
- …the research regulatory field in a clinical research or scientific setting, an institutional review board office, research administration, or regulatory ... Regulatory Specialist III functions as a liaison between the IRB of record for each study protocol, the Food...with the FDA and other regulatory authorities. Provides technical review and report preparation and submission of FDA required… more
- University of Pennsylvania (Philadelphia, PA)
- …biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and ... compliance, and data quality. It requires adherence to all University of Pennsylvania, IRB , and FDA guidelines and may require flexible hours. Job Description Job… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …Serving as research coordinator, the Manager , Research Projects liaises with the institutional review board ( IRB ) and implements research projects ... necessary modifications to methodologies and tools. + Manages all aspects of IRB and ethical review processes, including protocol submissions, updates,… more
- Actalent (Orlando, FL)
- …Specialist I provides vital regulatory support to the research team by managing all Institutional Review Board ( IRB ) and regulatory submissions and ... documents comply with Federal regulations, ICH/GCP guidelines, AAHRPP standards, and institutional policies. + Monitor review , approval, and clearance activities… more
- University of Pennsylvania (Philadelphia, PA)
- …with substance use disorders. Job Description Job Responsibilities + Prepare and process all Institutional Review Board ( IRB )through the IRB ... Demand clinicians (PMOD), the PI and Co- PI, program manager , and CRS Director. The SUN will be part...to all applicable PENN institutional committees for review and approval to start trial (eg, IRB… more
- AdventHealth (Tampa, FL)
- …local, state, and federal regulations Serves as liaison between Principal Investigators and the Institutional Review Board ( IRB ) and the Office of ... sponsors of research and administration. . Reviews all elements of the current institutional IRB approved informed consent (IC) document, according to current… more
