- Merck & Co. (Rahway, NJ)
- …and adverse event reporting requirements internally and externally.Our Clinical Research and Pharmacovigilance team push the boundaries of global healthcare ... through research and innovation. Through clinical trials and surveillance, we...including local language Informed Consents and translations. Interacts with IRB /IEC and Regulatory Authority for assigned protocols.Manages country deliverables,… more
- Stanford University (Stanford, CA)
- IRB Coordination Manager ( Research Compliance Manager 1) **Dean of Research , Stanford, California, United States** Compliance Legal Post Date Jan ... Sr. IRB Manager and the IRB Chair, you will conduct in-depth protocol review...relevant experience. In addition, our preferred requirements include: + Institutional Review Board professional certification… more
- University of Utah (Salt Lake City, UT)
- …regulations, institutional policies and procedures, and internal SOPs. 2. In coordination with the Research Manager develops strategy and operational ... Sr. CRC . assists the Principal Investigator in all IRB and regulatory submissions and clinical coordination ...Knowledge of Good Clinical Practices, FDA , HIPAA and IRB regulations; an understanding of research procedures;… more
- Cedars-Sinai (Los Angeles, CA)
- …and study conduct. + Works closely with a regulatory coordinator or directly with the Institutional Review Board ( IRB ) to submit initial applications, ... other regulatory / Institutional Review Board duties, budgeting duties, and assisting with research... and/or division members. + Assists division investigators and research program manager with IRB … more
- Johns Hopkins University (Baltimore, MD)
- … institutional and external clinical research requisites. + Responsible for Institutional Review Board ( IRB ) application submissions which include ... research needs. + Coordinates with contacts at the IRB office to expedite proposals, if applicable. + Responsible...investigator and site. Will work under supervision of Sr. Research Manager . + Demonstrates understanding and sensitivity… more
- AdventHealth (Denver, CO)
- …local, state, and federal regulations. Serves as liaison between Principal Investigators and the Institutional Review Board ( IRB ) and the Office of ... coordination , evaluation, and performance of nursing care for research participants and collecting data for assigned research...+ Serves as liaison between Principal Investigators and the Institutional Review Board ( IRB… more
- Stanford University (Stanford, CA)
- …Human Subjects Panel. + Coordinate new protocol submissions, renewals, and revisions to Institutional Review Board for multiple studies. Complete annual ... Department Clinical Research Manager **School of Medicine, Stanford,...reports to Institutional Review Board , CSTA, FDA and other regulatory… more
- University of Pennsylvania (Philadelphia, PA)
- …directed by the supervisor. He/she will be responsible for submission of studies to Institutional Review Board ( IRB ), ongoing maintenance of regulatory ... implement a plan of action. Work with the regulatory manager to ensure that submissions to the IRB...each study. Assist with preparation and processing of all Institutional Review Board ( IRB… 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 ... biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and… 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 ... biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and… 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 ... biological samples and related study documents, and collection of clinical data. Assist with Institutional Review Board ( IRB ) filings and inquiries, and… more
- University of Pennsylvania (Philadelphia, PA)
- …They may assist with Institutional Review Board ( IRB ) filings, sponsor and investigator filings and research related presentations. Participate in ... meetings. They will work closely with the Principal Investigator, research manager , and study team to identify... Institutional Review Board ( IRB ) filings, sponsor and investigator filings and research… more
- Catholic Health Initiatives (Lexington, KY)
- …study/regulatory, documents, applications and forms, including but not limited to the applicable Institutional Review Board ( IRB ) application form(s), ... Research Nurse (CRN) works with the CommonSpirit Health Research Institute Market Clinical Research Manager... research . + Demonstrated ability to perform all research coordination duties for multiple clinical trials… more
- Harvard University (Cambridge, MA)
- …communications, coordination and documentation associated with the use of a single Institutional Review Board (sIRB) across these multi-site studies and ... The Epidemiology Department is seeking a Regulatory and Compliance Manager for all PHACS-affiliated research projects. This...ensure the continued smooth and time-sensitive transition from local institutional review to ceded review … more
- University of Rochester (Rochester, NY)
- …DWG Clinical Research Manager . + Prepares and tracks/guides submission to Institutional Review Board ( IRB ) (CIRB, RSRB, Commercial IRB ... for the coordination and oversight of regulatory requirements of clinical research protocols. Under the direction of the Regulatory Manager and in… more
- Cleveland Clinic (Cleveland, OH)
- …case report forms and regulatory documents for the conduct of research required by Institutional Review Board ( IRB ), Sponsor and FDA. Collect and ... Project Manager oversees the administrative functions of single and/or multi- institutional research trials. You will coordinate/Manage daily organization and… 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 ... to procedures as needed and monitor results. Responsible for study coordination for investigator-initiated studies, multi-center research studies, and… more
- Johns Hopkins University (Baltimore, MD)
- …agencies. + Draft human subjects research study protocols for submission to the Institutional Review Board ( IRB ) and management of ongoing study ... Manager , CDHAI._** The center's extensive program portfolio includes research and education projects across a broad range of...and contribute high level operational management. + Work in coordination with research team to ensure accuracy,… more
- Pennsylvania State University (Hershey, PA)
- …of studies; ensures program compliance with government regulations, University policies, and Institutional Review Board ( IRB ) requirements, and ... Department of Neurology, in Hershey, PA is seeking a Research Project Manager . The Research ...direction, conduct, and reporting of studies, surveys and/or applied research projects + Review and make recommendations… more
- University of Colorado (Aurora, CO)
- …with NCI/CTEP requirements including but not limited to site rostering, NCI Central Institutional Review Board (NCI CIRB) authorization, and credentialing. + ... Cancer Screening Research Network (CSRN) Hub Program Manager ...**Preferred** **Q** **ualifications** **:** + Familiarity with NCI Central Institutional Review Board (CIRB), Clinical… more
