- IQVIA (Durham, NC)
- …manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award ... resolving project related issues where required. Ensure collaboration across Regulatory & Site Activation, including communication with regions and countries,… more
- University of Pennsylvania (Philadelphia, PA)
- …the initiation of Phase I-V clinical trials with a focus on required regulatory start -up approvals and associated site initiation documentation. Reporting to the ... CRU OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Start -Up Specialist-CC to facilitate, with minimal supervision, the regulatory … more
- Houston Methodist (Houston, TX)
- …position for Department of Medicine will also work with industry sponsors' or grant funder's regulatory personnel for study regulatory start up and study ... At Houston Methodist, the Senior (Sr.) Regulatory Compliance Specialist position is responsible for leading,...is responsible for leading, coordinating and performing study specific regulatory processes such as local IRB submissions or external… more
- University of Miami (Miami, FL)
- … Analyst II reviews, prepares, and provides oversight for initial and subsequent regulatory submissions from study start -up through study closure as well as ... the maintenance of regulatory documents to ensure compliance with applicable requirements and...the process of study submissions (initial and amendment) and regulatory document maintenance; serves as point of contact for… more
- Action for a Better Community, Inc. (Rochester, NY)
- …guidance, training and monitoring for program partners and delegates as required by Head Start funding sources and regulatory bodies. The Head Start ... Job Vacancy Program: Head Start Location: 400 West Avenue Position: Head Start Recruitment, Retention and Staff Development Manager Hours: 37.5 hrs./wk. 52… more
- Dana-Farber Cancer Institute (Boston, MA)
- …for new projects and amendments. + Relays and discusses operational, logistical, and regulatory challenges related to the start -up, active, and closeout phases ... The Assistant Regulatory Operations Manager (AROM) is a newly created...consultation. + Has a good understanding of clinical trials start -up, active and close out phases. + Has a… more
- University of Washington (Seattle, WA)
- …regulations. This position will be responsible for expeditious coordination of the regulatory submissions in the study start -up phase to meet sponsor ... of Medicine: Hematology and Oncology has an outstanding opportunity for Regulatory Coordinator.** **Position Purpose:** The University of Washington's Division of… more
- Actalent (Boston, MA)
- …(WIs), quality of designated deliverables, and project timelines. + Perform regulatory , start -up, and maintenance activities according to applicable regulations, ... for planning, setting up, managing, executing, and overseeing RWE projects from start to finish. Ensure projects are delivered on time, within budget, and… more
- Abbott (Dallas, TX)
- …Contracts Associate), as needed. Manage all aspects of study lifecycle to include site regulatory and quality: + Start Up + Nominate, approach, and complete ... aspects of the start -up process and site initiation visits + Understand regulatory and legal requirements for study participation at a level that allows for… more
- Abbott (Pleasanton, CA)
- …Associate), as needed. **Manage all aspects of study lifecycle to include site regulatory and quality:** + ** Start Up** + Nominate, approach, and complete ... aspects of the start -up process and site initiation visits + Understand regulatory and legal requirements for study participation at a level that allows for… more
- Huntington National Bank (Columbus, OH)
- …The Regulatory Relations Specialist - Senior is responsible for facilitating regulatory exams from start to finish and assisting with remediation of ... regulatory findings. The Regulatory Relations team has extensive exposure across the Company...closely with business units to ensure comprehensive responses to regulatory requests. The Regulatory Relations group is… more
- IQVIA (San Diego, CA)
- …daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start -Up teams, to ensure a complete and accurate ... File delivery. **Essential Functions** * Assist Clinical Research Associates (CRAs) and Regulatory and Start -Up (RSU) team with accurately updating and… more
- Mount Sinai Health System (New York, NY)
- …regarding specific protocols. + Manage clinical trials portfolio and assure timely regulatory start -up of protocols. + Monitor accruals and identify ... of Good Clinical Practice, Human Subject Protection, clinical trial design, regulatory processes, and clinical development process. + Strong verbal and written… more
- University of Pennsylvania (Philadelphia, PA)
- …assessments, liaising with sponsors, vendors, CROs & PI teams, and completing start -up regulatory documents and submissions. Develop source docs, training ... includes overall management of research projects, supervision of research staff, regulatory submissions, recruitment strategy, and development of key study documents… more
- University of Pennsylvania (Philadelphia, PA)
- …Responsibilities include preparing and processing regulatory documents to all regulatory committees from study start up to study completion. Interacting ... preparing and processing regulatory documents to all regulatory committees from study start up to...documents to all regulatory committees from study start up to study completion. Interacting with study sponsors,… more
- University of Pennsylvania (Philadelphia, PA)
- …organizations (CROs), the NCI Cooperative/Clinical Network Groups to prepare and organize regulatory documentation for study start up day to day oversight ... trials that offer cutting-edge oncology treatments. Contingent upon funding.The Regulatory Affairs Administrative Coordinator provides high-level, administrative support for… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Regulatory Operations Manager, Clinical Research Manager and / or ... directly for the Clinical Trials Office to complete the regulatory requirements of the clinical research project. The RC coordinates aspects of protocol submissions,… more
- Dana-Farber Cancer Institute (Brookline, MA)
- The Regulatory Coordinators (RC) works under the direction of the Principal Investigator(s), Clinical Research Manager and / or directly for the Clinical Trials ... Office to complete the regulatory requirements of the clinical research project. The RC...Trial Management** + Track and manage assigned new protocol start -up packet; initiate, facilitate and monitor study start… more
- University of Miami (Miami, FL)
- …Provides regulatory support for multiple clinical trials from study start -up through study closure. Generates and updates essential regulatory documents, ... Miami/UHealth Department of SCCC has an exciting opportunity for a Full Time Remote Regulatory Analyst 1. CORE JOB SUMMARY: The SCCC department is seeking a … more
- American Electric Power (Columbus, OH)
- …involves providing expert accounting services to support development and execution of regulatory strategy across the AEP system. Includes managing regulatory ... activities. Position requires interaction and communication with various parties to regulatory proceedings, including the presentation of written and oral testimony… more