- 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 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 ... Summary Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start - Up Specialist-CC to facilitate, with minimal… more
- Arkansas Children's (Little Rock, AR)
- …leadership and stakeholders. *Provide training and guidance to study teams on start - up procedures, regulatory requirements, and institutional workflows. ... Type:** Full time **Department:** CC033020 Clinical Research Operations **Summary:** The Study Start - Up Project Manager serves as the institutional lead and… more
- University of Washington (Seattle, WA)
- …some independent decision making in all aspects of the research study start up process as well as ongoing regulatory study maintenance. This position will be ... responsible for expeditious coordination of the regulatory submissions in the study start - up phase to meet sponsor and institutional timelines, which is a… more
- IQVIA (Durham, NC)
- …Office Job Overview Under moderate supervision, executes the feasibility, site identification regulatory , start - up , and maintenance activities in accordance ... and accuracy. * Inform team members of completion of regulatory contractual. and other documents for individual sites. *...complete project specific information. * Review, track and follow up the progress, the approval and execution of required… more
- Abbott (Abbott Park, IL)
- …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 (Minneapolis, MN)
- …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
- Vitalief (New Brunswick, NJ)
- …(for Industry, NIH, Cooperative Group, NCI and Investigator Initiated sponsored trials); Regulatory work required for start - up documents; Processes related ... work for Industry, NIH, Cooperative Group, NCI and Investigator Initiated sponsored trials; Regulatory work for start - up document; Contract review and… 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 ... study enrollment, establishing a database of patients, protocol treatment and follow- up care for patients participating in clinical trials. + Collaborates with… 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