- 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
- Rush University Medical Center (Chicago, IL)
- …of each case. **Summary:** The position supports the Office of Research Affairs ' Clinical Research Administration Division, their clinical department ... Practices and Good Documentation Practices. * Demonstrated knowledge of current NIH and/or FDA regulations and guidelines related to clinical research. * Strong… more
- Pfizer (South San Francisco, CA)
- …and external partners, such as project leaders, research units, biostatistics, regulatory affairs , clinical pharmacology, human genetics, translational ... of Oncology Drug Development especially in Early Development + Strong knowledge of clinical procedures, ICH guidelines,GCP and familiarity with FDA , EMA, and… more
- University of Pennsylvania (Philadelphia, PA)
- …health and wellness programs and resources, and much more. Posted Job Title Clinical Research Coordinator B/C - Epidemiology Division Job Profile Title Clinical ... will assist in the coordination and management of multiple clinical trials along with other research projects and responsibilities...be expected to adhere to all University of Pennsylvania, FDA , and GCP guidelines. The CRC-B/C will be responsible… more
- Mount Sinai Health System (New York, NY)
- …The Regulatory Project Coordinator will be responsible for supporting the regulatory affairs team in managing and coordinating regulatory projects. ... research. **Responsibilities** ** Regulatory Oversight & Documentation** + Coordinate regulatory activities for multi-site clinical trials, including domestic… more
- Terumo Medical Corporation (Somerset, NJ)
- …ID: 5279 Location: Somerset, NJ, US Company: Terumo Medical Corporation Department: Clinical Affairs Terumo Medical Corporation (TMC) develops, manufactures, and ... / 14971, 21 CFR 50/56/812, and ICH-GCP and applicable regulatory requirements, while driving continuous improvement in clinical.../ 13485 / 14971, 21 CFR 50/56/812, ICH-GCP, and FDA regulations * Strong auditing and risk management skills.… more
- University of Pennsylvania (Philadelphia, PA)
- …needed. Coordinate non-therapeutic studies and complex Phase I, II, or III oncology clinical trials. + Assist the Regulatory Coordinator by preparing components ... programs and resources, and much more. Posted Job Title CLINICAL RESEARCH COORDINATOR B/C Job Profile Title Clinical...IRB stipulations, queries and concerns; remain aware of the regulatory statuses for assigned protocols. + Lead or contribute… more
- Takeda Pharmaceuticals (Boston, MA)
- …Oversees and leads all clinical science activities involved in interactions with FDA , other regulatory agencies and key opinion leaders relevant to assigned ... empower you to shine? Join us as a Executive Medical Director, Oncology Clinical Sciences in our Cambridge office. At Takeda, we are transforming the pharmaceutical… more
- Abbott (Austin, TX)
- … Clinical Operations, Clinical Data Science and Analytics, Marketing, Regulatory , Legal, Clinical Affairs , Research and senior management to ... PM and categorization of A and B categorization by FDA . + Remain current on developments in field(s) of...Remain current on developments in field(s) of expertise, applicable clinical requirements and regulatory restrictions; and a… more
- Takeda Pharmaceuticals (Boston, MA)
- …and reporting to regulatory agencies. + Act as strategic partner to Clinical Program Quality for complex clinical deviations and Serious Breaches. + Review ... experience in GCP Quality/Compliance. + Advanced knowledge of pharmaceutical development, medical affairs and GCP/GVP regulations including FDA , EU, MHRA, PMDA… more