- Abbott (San Diego, CA)
- …international regulatory guidelines, policies and regulations Ethical guidelines of the regulatory profession, clinical research and regulatory ... regulatory filing strategies based on proposed preclinical, clinical , and manufacturing changes. + Monitor the...in a regulated industry, +7 years of experience in regulatory preferred but may consider quality assurance, research… more
- St. Luke's University Health Network (Allentown, PA)
- …the financial management, regulatory compliance, and long-term sustainability of SLUHN Clinical Trials and Research programs within the Clinical Trials ... the department and all clinical trials and research programs and studies; monitor and mitigate...financial and billing requirements safeguarding both financial integrity and regulatory compliance across all clinical studies +… more
- Dartmouth Health (Lebanon, NH)
- …professional guidelines and code of ethics related to the conduct of clinical research and Dartmouth-Hitchcock (D-H) and project specific training requirements. ... consent, enroll, randomize and collect data on study participants following the research study protocol. Coordinate the clinical trial under the supervision… more
- University of Rochester (Rochester, NY)
- …**Continuing Education:** Demonstrates accountability for continuous learning related to clinical research . + Keeps current with study-specific training, ... I. ** Regulatory Oversight:** Oversees and manages the regulatory details for multiple assigned research studies....Attends training sessions and other educational opportunities related to clinical research in order to keep current… more
- Abbott (Santa Clara, CA)
- …regulatory review. + Monitor and submit applicable reports to regulatory authorities. + Evaluate proposed preclinical, clinical and manufacturing changes ... for submission filing. + Compile, prepare, review and submit regulatory submissions to authorities. + Monitor impact...years of experience. + 2-3 years of experience in regulatory preferred but may consider quality assurance, research… more
- Lilly (Indianapolis, IN)
- …byleveragingteam expertise, as well as scientific, drug/device clinical development and knowledgefromhealth authorities such as ... with Global Regulatory Team. + Continually expand therapeutic area knowledge. Monitor and assess impact of relevant global regulations, guidance, and current … more
- IQVIA (Durham, NC)
- …**\#LI-Remote** **\#LI-NITINMAHAJAN** IQVIA is a leading global provider of clinical research services, commercial insights and healthcare intelligence ... Clinical Operations with statistical expertise. + Contribute to clinical study reports and other regulatory documents...other benefits. IQVIA is a leading global provider of clinical research services, commercial insights and healthcare… more
- Dartmouth Health (Lebanon, NH)
- …and finances of existing trials. Responsibilities * Ensures quality and success of clinical research endeavors. * Leads the development of operational and ... established research policy. * Supervises all assigned clinical research personnel either directly or via...and study Principal Investigators (PI) to develop, manage and monitor clinical trial contracts and budgets; monitors… more
- University of Miami (Miami, FL)
- …other Department Specifics The Individual will be responsible for the day-to-day management of Clinical Research Services (CRS) clinical research staff ... (SDGs). Management would include the oversight of over 125 clinical research protocols, which have resulted in...Ensures the implementation of training is implemented into daily research procedures. Assess and monitor the implementation… more
- Johns Hopkins University (Baltimore, MD)
- …Generate monthly enrollment and screening reports and submit to NIH via CROMS. + Monitor , document, and report adverse events to regulatory agencies. + Report ... **Specific Duties & Responsibilities** _Database Management_ + Maintain and update research databases, ensuring compliance with regulations and entry. + Develop data… more