- HonorHealth (Scottsdale, AZ)
- …problem solving and getting involved in the planning process. Serves as a representative at the Institutional Review Board ( IRB ). Serve as an ad hoc ... implementing the preparation, compounding and dispensing of investigational drugs. The research pharmacist ensures compliance with the required record-keeping,… more
- New York Medical College (Hawthorne, NY)
- …team and clinical research nurses and team. Responsibilities Assist in new IRB application and annual renewal process of COG, sponsored, local and other multi- ... trial set up, initial and ongoing regulatory submission and IRB activities, subject screening and enrollment, specimen collection and... with the Good Clinical Practice guidelines in clinical research . Monitor study patients for adverse events… more
- Axogen (Tampa, FL)
- …site GCP compliance , trouble shoot issues and facilitate resolution, and monitor safety at the site. The position will also conduct site qualification visits ... as a resource for new CRAs in setting a high standard for site management, data review , and SOP compliance . They will also assist, as needed, as a back-up… more
- Loyola University Chicago (Chicago, IL)
- …completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. *Assemble study ... and other study related documents, and complete study documents/case report forms. *Ensure compliance with research protocols, and review and audit case… more
- The Ohio State University (Dublin, OH)
- …and local regulations; develops and prepares protocol submissions to local and national Institutional Review Boards ( IRB ), including writing of abstract, ... of assigned protocols and informed consent forms prior to IRB review ; ensures timely submission of protocol...compliance ; establishes and oversees tracking system to continually monitor progress of protocol review and status… more
- Medix (Atlanta, GA)
- …is highly desirable. Key Responsibilities: Prepare, submit, and track regulatory documents for Institutional Review Board ( IRB ) submissions, protocol ... is highly desirable. Key Responsibilities: Prepare, submit, and track regulatory documents for Institutional Review Board ( IRB ) submissions, protocol… more
- Boston Medical Center (Boston, MA)
- …Security/Information Technology, Legal and Compliance , Clinical Research and Institutional Review Board , Patient Advocacy, Quality & Safety, and ... matters via consultations to the Privacy office. Team Leadership Monitor intake and reports to the Compliance ...completion. Proactively recommend topics to bring to the bi-weekly Research Compliance meeting with support from the… more
- Regional Cancer Care Associates LLC (Sparta, NJ)
- …with protocol requirements. Interacts with Research Sponsors, site personnel, IRBs ( Institutional Review Boards), and other research entities regarding ... ready to be a pivotal force in groundbreaking cancer research ? RCCA is in search of an outstanding ...compliance with RCCA SOP, US Oncology Policies, HIPAA, IRB , FDA, and ICH-GCP guidelines at all times. Provide… more
- Children's Hospital of Philadelphia (Philadelphia, PA)
- …subject billing issues Develop advertisement materials Act as liaison for research subject, investigator, IRB , sponsor, and healthcare professionals Organize ... and outreach Provide training to junior staff on conduct of research studies Document investigational product (drug/device) accountability Self- monitor and… more
- Virginia Commonwealth University (Richmond, VA)
- …level pre-award reporting for areas assigned. Responsibility 2 (30%): Post-Award Research Administration and Compliance Monitoring Task 1: Provide financial ... CIMR Research Administrator | School of Medicine/Neurology Benefits of...index requests seeking department approvals as needed. Task 7: Review terms and conditions of awards and communicate special… more
- Wayne State University (Detroit, MI)
- Research Compliance Monitor , IRB Wayne...For-Cause Audits as requested by the Institutional Review Board Committee or Human Research ... compliance . Submit monitoring reports to the Human Research Protection Program Administration and to the Institutional...and protocol violations and direct to committee Chair, individual Institutional Review Board , institutional… more
- Alaka'ina Foundation Family of Companies (Camp Lejeune, NC)
- …Companies (FOCs) is possibly looking for an Institutional Review Board Administrative Support to provide research support administration services for our ... Institutional Review Board Administrative...providing direct administration or management of a human subjects research IRB conducting active research … more
- Virtua Health (Marlton, NJ)
- …Supports the IRB by triaging and managing submissions through a pre- review process for completeness. Supports the research community by providing policy ... before being reviewed by the IRB . Manages IRB documents, website, training compliance , files and...IRB member meeting attendance to ensure quorum and monitor quorum during IRB meetings. Serve as… more
- Fairfield University (Fairfield, CT)
- …and Compliance is responsible for overseeing the daily operations of the Institutional Review Board ( IRB ) at Fairfield University. This ... to the IRB , ensures consistent and thorough pre- review of research protocols, and supports the...guidance. + **Regulatory & Administrative Support** + Ensure university compliance with federal regulations, institutional policies, 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 ... AEs, SAEs, and UADEs reports to the Investigator and Institutional Review Board ( IRB...request; storage, and shipping/delivery of biospecimens per protocol and institutional policies; reviewing and approving research billing;… more
- Cedars-Sinai (Los Angeles, CA)
- …term follow-up patients only. + Assists supervising staff with regulatory submissions to the Institutional Review Board ( IRB ) including submission of ... for this purpose. The database is also used to monitor subject participation, assure regulatory compliance and...and Drug Administration (FDA) and local Institutional Review Board . + Maintains research … 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 ... Portability and Accountability Act (HIPPA) protocol development and ensure compliance of research operations with protocols. May assist in developing and… more
- Stanford University (Stanford, CA)
- …for completion and accuracy with source documents. Prepare regulatory submissions and ensure institutional Review Board renewals are completed. + Assemble ... documents, and complete study documents/case report forms. + Ensure compliance with research protocols, and review...and research data in appropriate files per institutional and regulatory requirements. + Participate in monitor… more
- University of Utah (Salt Lake City, UT)
- …of oncology, and oncology related research + Prior experience with Institutional Review Board ( IRB ) procedures + Strong written and oral ... four years of clinical research experience that includes regulatory compliance monitoring/auditing, IRB application submission, and experience in human… more
- University of Miami (Miami, FL)
- …and participant compensation/reimbursement records. + Prepares and submits annual continuing reviews to the Institutional Review Board ( IRB ). + Notifies ... community agencies, and study sponsors. + Updates appropriate agencies (such as sponsors, IRB , etc.) regarding current status of research project. + Provides… more
