- 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 ... of education and experience required. Advanced degree preferred. Minimum 4 years regulatory start - up experience required; at least 2 years' experience in the… more
- IQVIA (Durham, NC)
- …training and experience. * In-depth knowledge of applicable clinical research regulatory requirements (ie, Good Clinical Practice (GCP) and International Conference ... on Harmonization (ICH) guidelines). * Good leadership skills. * Computer skills including proficiency in use of Microsoft Word, Excel and PowerPoint. * Written and verbal communication skills including good command of English. * Excellent organizational and… more
- University of Pennsylvania (Philadelphia, PA)
- …issues impacting regulatory compliance, and ensure smooth transition of protocols from regulatory start up to study activation. They will assist the ... with facilitating and tracking the flow of new research studies through the start - up process, by identifying regulatory obstacles to activation, and propose… more
- ICON Clinical Research (NC)
- …Review Board (IRB) Submissions: + Proficiently collect, review, organize and assemble regulatory initial start - up and maintenance submission packages to ... Study Start Up Associate II - Home...Study Start Up Associate II - Home Based (San Diego,... regulatory affairs, with specific experience in study start - up activities. + Ability to work on… more
- University of Colorado (Aurora, CO)
- …and institutional research regulatory standards and guidelines. + Manage all regulatory aspects of study start - up and ongoing maintenance, ensuring ... **Research Services Professional ( Regulatory and Pre-Award) - Open Rank** **Description** **University of Colorado Anschutz Medical Campus** **Department:… more
- Dana-Farber Cancer Institute (Boston, MA)
- …Board (and other institutions' IRBs) + Identify and manage operational, logistical, and regulatory challenges related to the start - up , active, and closeout ... relevant to children with cancer and blood disorders. CTIP Regulatory unit will provide pan-CTIP support as part of...proficient knowledge of and ability to execute clinical trials start - up , active and close out phases +… more
- Georgetown Univerisity (Washington, DC)
- …for regulatory correspondence and plays a key role in facilitating study start - up and ongoing regulatory maintenance. Strong interpersonal skills are ... IRB applications, amendments, safety reports, protocol deviations) + Maintain accurate and up -to-date regulatory files for clinical research studies + Ensure… more
- Georgetown Univerisity (Washington, DC)
- …for regulatory correspondence and plays a key role in facilitating study start - up and ongoing regulatory maintenance. Strong interpersonal skills are ... documents (eg, IRB applications, amendments, safety reports) + Maintain accurate and up -to-date regulatory files for clinical research studies + Ensure… more
- Weill Cornell Medical College (New York, NY)
- …direction, oversees the regulatory aspects of clinical trials from start - up through study closeout. **Job Responsibilities** + Coordinates designated ... enrollment. Submits eligibility exceptions to the IRB. + Ensures maintenance of up -to-date regulatory records in compliance with established regulations and… 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