• Manager, Regulatory and Start

    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
    IQVIA (10/08/24)
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  • Clinical Research Regulatory Specialist B…

    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
    University of Pennsylvania (09/14/24)
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  • Senior Regulatory Compliance Specialist

    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
    Houston Methodist (10/09/24)
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  • Regulatory Analyst 2 - Remote

    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 Miami (10/02/24)
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  • Regulatory Coordinator

    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
    University of Washington (09/25/24)
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  • Assistant Regulatory Operations Manager

    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
    Dana-Farber Cancer Institute (10/17/24)
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  • Associate Director, RWE Program Delivery

    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
    Actalent (11/26/24)
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  • Senior Clinical Site Lead - Dallas/Fort Worth

    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 (11/27/24)
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  • Clinical Site Lead - Southern CA Territory

    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
    Abbott (11/26/24)
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  • Clinical Program Manager (RN/NP Required) - Tisch…

    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
    Mount Sinai Health System (11/14/24)
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  • Clinical Trial Assistant

    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
    IQVIA (10/24/24)
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  • Clinical Research Coordinator C (Department…

    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 (11/06/24)
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  • Project Manager A/B

    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 (10/27/24)
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  • Administrative Coordinator (Abramson Cancer…

    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
    University of Pennsylvania (10/27/24)
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  • Study Start Up Head (Sr. Director)

    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
    Astellas Pharma (11/14/24)
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  • Clinical Research Project Manager A/B

    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
    University of Pennsylvania (11/26/24)
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  • Senior Regulatory Coordinator

    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 (11/09/24)
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  • Regulatory Coordinator I

    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
    Dana-Farber Cancer Institute (11/02/24)
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  • Manager Research Project A

    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 Pennsylvania (10/03/24)
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  • Regulatory Analyst 1

    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
    University of Miami (10/05/24)
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