- University of Pennsylvania (Philadelphia, PA)
- …of health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A Job Profile Title Clinical Research Coordinator A ... This position will assist in the management of multiple clinical trials and responsibilities in specific research area. Coordinate.... Coordinate IRB submissions and renewals in accordance with FDA and IRB guidelines . Assure compliance with the… more
- Cedars-Sinai (Beverly Hills, CA)
- …and submission of investigator-initiated study applications including IND submissions to the FDA . + Manages Clinical Coordinating Center (CCC) with academic and ... in monitoring and auditing activities as well as site visits from sponsors, Clinical Research Organizations and FDA . + Conceptualizes and builds research… more
- University of Colorado (Aurora, CO)
- …the Food and Drug Administration ( FDA ), study protocols, department, hospital/ clinical standard operating procedures and other regulatory guidelines + ... Clinical Sciences Professional (Open Rank)- Pediatric Endocrinology Research...visits, data management, development and oversight of multisite protocols, regulatory affairs , and excellent interpersonal skills with… more
- Takeda Pharmaceuticals (Lexington, MA)
- …as clinical liaison to Global Device Team, including engineering, regulatory affairs , quality, and commercial functions + Coordinate interdepartmental ... principles, while fostering collaboration across multidisciplinary teams to deliver device clinical outcomes that exceed quality benchmarks and regulatory … more
- University of Pennsylvania (Philadelphia, PA)
- …to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is an integral and ... clinical research investigators, Research Team Leaders, our clinical research nurse(s), and regulatory coordinator. The...allows you to relax, take vacations, attend to personal affairs , recover from illness or injury, spend time with… more
- Takeda Pharmaceuticals (Boston, MA)
- …experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA ... + Experience must include successful development and implementation of a clinical or pharmacovigilance audit program, hosting/leading regulatory inspections,… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …applicable to the design, analysis of clinical trials and process for regulatory submissions across difference regions (ICH, FDA , EMA and others). + Advanced ... Clinical Sciences, Outcomes, Digital Health, Pharmaceutical Sciences/Device, and Global Regulatory Affairs . + Advanced knowledge of regulatory guidance… more
- Sanofi Group (Cambridge, MA)
- …strategy with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs , biostatistics, drug ... SOPs, GCP, ICH guidelines and other regulations + Review documents supporting clinical development such as Investigator's brochure, regulatory documents for IND… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B Job Profile Title Clinical Research Coordinator A ... Research Coordinator (CRC) will support the conduct of Phase I-IV clinical trials, registries, and possibly grant-funded research studies for the Advanced Lung… more
- University of Pennsylvania (Philadelphia, PA)
- …safety, protocol compliance, and data qualify. Adhere to all University of Pennsylvania, FDA , and GCP guidelines. Clinical Coordinator B, in addition to the ... health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator A/B/C Job Profile Title Clinical Research Coordinator A… more