- IQVIA (Durham, NC)
- …Provide overall guidance and oversight of multi-regional and multi-protocol programs during initial start - up and maintenance phase as an integral member of the ... manage the delivery of all required site activation, maintenance and regulatory activities for selected studies or multi-protocol programs, including pre-award… more
- University of Pennsylvania (Philadelphia, PA)
- …of the initiation of Phase I-V clinical trials with a focus on required regulatory start - up approvals and associated site initiation documentation. Reporting ... The CRU OCCR Regulatory Affairs Office seeks a full-time Regulatory Affairs Start - Up Specialist-CC to facilitate, with minimal supervision, the … more
- Houston Methodist (Houston, TX)
- …also work with industry sponsors' or grant funder's regulatory personnel for study regulatory start up and study regulatory maintenance throughout ... 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
- University of Washington (Seattle, WA)
- …institutional regulations. This position will be responsible for expeditious coordination of the regulatory submissions in the study start - up phase to meet ... studies. This individual will be responsible for overseeing the regulatory coordination of up to 30 active...outside of the research team. * Assist in study start up activities. * Assist in writing… 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 ... 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. +… more
- Actalent (Boston, MA)
- …instructions (WIs), quality of designated deliverables, and project timelines. + Perform regulatory , start - up , and maintenance activities according to ... up , managing, executing, and overseeing RWE projects from start to finish. Ensure projects are delivered on time,...sites and internal project team members. + Prepare site regulatory documents, reviewing for completeness and accuracy. + Review,… more
- Abbott (Dallas, TX)
- …Site Contracts Associate), as needed. Manage all aspects of study lifecycle to include site regulatory and quality: + Start Up + Nominate, approach, and ... + Identify, develop, and maintain sites capable of delivering start - up goals, study participation levels and required...up process and site initiation visits + Understand regulatory and legal requirements for study participation at a… more
- Abbott (Pleasanton, CA)
- …Contracts Associate), as needed. **Manage all aspects of study lifecycle to include site regulatory and quality:** + ** Start Up ** + Nominate, approach, and ... + Identify, develop, and maintain sites capable of delivering start - up goals, study participation levels and required...up process and site initiation visits + Understand regulatory and legal requirements for study participation at a… more
- Mount Sinai Health System (New York, NY)
- …Staff 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
- IQVIA (San Diego, CA)
- …Perform daily administrative activities, in conjunction with the Clinical Research Associates and Regulatory and Start - Up teams, to ensure a complete and ... **Essential Functions** * Assist Clinical Research Associates (CRAs) and Regulatory and Start - Up (RSU) team with accurately updating and maintaining… more
- University of Pennsylvania (Philadelphia, PA)
- …platform. Responsibilities include preparing and processing regulatory documents to all regulatory committees from study start up to study completion. ... include preparing and processing regulatory documents to all regulatory committees from study start up to study completion. Interacting with study… more
- University of Pennsylvania (Philadelphia, PA)
- …feasibility assessments, liaising with sponsors, vendors, CROs & PI teams, and completing start - up regulatory documents and submissions. Develop source docs, ... with all regulatory organizations. S/he will play a key role in study start - up , intake & feasibility for many studies. The Project Manager will provide… more
- University of Pennsylvania (Philadelphia, PA)
- …research organizations (CROs), the NCI Cooperative/Clinical Network Groups to prepare and organize regulatory documentation for study start up day to day ... trials that offer cutting-edge oncology treatments. Contingent upon funding.The Regulatory Affairs Administrative Coordinator provides high-level, administrative support for… more
- Astellas Pharma (Northbrook, IL)
- …objectives), while adhering to budget targets + Efficiently manage allocations of study start - up staff which includes regulatory document collection and site ... will oversee and provide strategic direction for the global execution of study start up activities for all Clinical Development Studies (Early Development &… more
- University of Pennsylvania (Philadelphia, PA)
- …A Job Responsibilities + Manage single and multi-site clinical trials (including study start up , regulatory submissions, daily operations, external site ... + Manage single and multi-site clinical trials (including study start up , regulatory submissions, daily operations, external site communications… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …third-party auditors. **Clinical Trial Management** + Track and manage assigned new protocol start - up packet; initiate, facilitate, and monitor study start - ... The Regulatory Coordinators (RC) works under the direction of...and collaborate with clinical trial key stakeholders through the start - up process, provide regular updates and ensure… more
- Dana-Farber Cancer Institute (Brookline, MA)
- …party auditors. + **Clinical Trial Management** + Track and manage assigned new protocol start - up packet; initiate, facilitate and monitor study start - up ... The Regulatory Coordinators (RC) works under the direction of...and collaborate with clinical trial key stakeholders through the start - up process, provide regular updates and ensure… more
- University of Pennsylvania (Philadelphia, PA)
- …Job Responsibilities + Manage single and multi-site clinical trials (including study start up , regulatory submissions, daily operations, external site ... will also participate in scheduling and serve as a back- up for conducting study visits for assigned studies, in...recording forms. The Research Project Manager will assist in regulatory oversight of the research coordinators and correspond with… more
- University of Miami (Miami, FL)
- …sponsors. Provides regulatory support for multiple clinical trials from study start - up through study closure. Generates and updates essential regulatory ... has an exciting opportunity for a Full Time Remote Regulatory Analyst 1. CORE JOB SUMMARY: The SCCC department...submission to the Institutional Review Board (IRB) from study start - up to study closure, including communicating with… more