- 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 ... 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 Director ... tracking the flow of new research studies through the start -up process, by identifying regulatory obstacles to...studies through the start -up process, by identifying regulatory obstacles to activation, and propose improvements to the… more
- ICON Clinical Research (NC)
- …Review Board (IRB) Submissions: + Proficiently collect, review, organize and assemble regulatory initial start -up and maintenance submission packages to Central ... of 2 years of experience in clinical research or regulatory affairs, with specific experience in study start -up activities. + Ability to work on site in San… 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 studies ... **Research Services Professional ( Regulatory and Pre-Award) - Open Rank** **Description** **University of Colorado Anschutz Medical Campus** **Department:… more
- Dana-Farber Cancer Institute (Boston, MA)
- …(and other institutions' IRBs) + Identify and manage operational, logistical, and regulatory challenges related to the start -up, active, and closeout phases ... 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 + Very proficient… more
- Emory Healthcare/Emory University (Atlanta, GA)
- …Coordinate protocol activation/maintenance process and communicates to allow for enrollment to start and maintain once regulatory documents (eg DSMC review) are ... problems and takes a leadership role in resolving. + Lead study start -up/maintenance: prepare and submit all required regulatory documents for new/current… more
- Georgetown Univerisity (Washington, DC)
- … regulatory correspondence and plays a key role in facilitating study start -up and ongoing regulatory maintenance. Strong interpersonal skills are essential, ... a difference in the world. Requirements Job Overview The Regulatory Coordinator plays a critical role in ensuring ...Regulatory Coordinator plays a critical role in ensuring regulatory compliance and oversight of a portfolio of clinical… more
- Weill Cornell Medical College (New York, NY)
- …when Hired for NYC Offices **Position Summary** Under general direction, oversees the regulatory aspects of clinical trials from start -up through study closeout. ... Title: Regulatory Specialist-CCTO Location: Upper East Side Org Unit: Regulatory Work Days: Monday-Friday Weekly Hours: 35.00 Exemption Status: Non-Exempt Salary… more
- Georgetown Univerisity (Washington, DC)
- … regulatory correspondence and plays a key role in facilitating study start -up and ongoing regulatory maintenance. Strong interpersonal skills are essential, ... a difference in the world. Requirements Job Overview The Regulatory Coordinator plays a critical role in ensuring ...Regulatory Coordinator plays a critical role in ensuring regulatory compliance and oversight of a portfolio of clinical… more