- 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 ... organize and maintain all regulatory affairs documentation/files as required. The Regulatory Affairs Start -Up Specialist is expected to resolve, with minimal… more
- University of Colorado (Aurora, CO)
- …ensuring compliance with IRB consenting policies. + Direct and manage all regulatory study start -up, and maintenance activities ensuring that opening timelines ... ** Regulatory and Compliance Program Director** **Description** **University of...Colorado Anschutz Medical Campus** **Department: Cancer Center** **Working Title: Regulatory and Compliance Program Director** **Position #:660200 - Requisition… more
- Rush University Medical Center (Chicago, IL)
- …staff. . Leads regular, timely meetings to track progress of study regulatory activities, including study start -up, maintenance, close-out activities; and ... vary depending on the circumstances of each case. **Summary:** The Clinical Research Regulatory Compliance Manager serves as the subject matter expert for a team of… more
- Houston Methodist (Houston, TX)
- …Harmonization (ICH). This position will work closely with the study teams for study start -up regulatory paperwork, maintain regulatory documents such as DOA ... At Houston Methodist, the Regulatory Compliance Specialist position is responsible for coordinating...position is responsible for coordinating and performing study specific regulatory processes such as local IRB and external IRB… 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
- American Express (New York, NY)
- …Preparedness team + Conduct readiness assessments for impacted areas prior to the start of regulatory exams/reviews to identify potential gaps and solutions. + ... schedule. **Minimum Qualifications:** + 3 years of experience in Regulatory reporting. + Strong understanding of US Regulatory... Regulatory reporting. + Strong understanding of US Regulatory and US GAAP requirements. + Ability to manage… more
- Action for a Better Community, Inc. (Rochester, NY)
- …guidance, training and monitoring for program partners and delegates as required by Head Start funding sources and regulatory bodies. The Head Start ... Job Vacancy Program: Head Start Location: 400 West Avenue Position: Head Start Recruitment, Retention and Staff Development Manager Hours: 37.5 hrs./wk. 52… more
- 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 ... Temporary Employee - Non-Exempt Job Description Ophthalmology seeks a part-time Regulatory Affairs Start -Up Specialist-CC to facilitate, with minimal supervision… more
- Johns Hopkins University (Baltimore, MD)
- … Regulatory Specialist_** who will be responsible for managing regulatory start -up of clinical trials, assisting development of investigator-initiated ... continuing education trainings for the specific Urology Clinical Research Program. Regulatory start -up activities include site evaluation visits, feasibility… more
- Sanofi Group (Swiftwater, PA)
- …role you will provide expert guidance on country and site selection strategies, regulatory considerations and start -up timelines, as well as patient access ... therapeutically customized site identification and patient strategy with the start -up team, collaborates with Project Management Leads, Clinical Trial Management,… more
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