- Novant Health (Winston Salem, NC)
- …our cutting-edge Structural Heart Program. We're looking for a Structural Heart Regulatory Coordinator who's passionate about ensuring compliance and supporting ... BSN are Required for this position. + Experience in regulatory affairs or healthcare compliance preferred. +...five years exp in disease/condition management programs or relevant clinical exp in the management of cardiac patients, required.… more
- Stryker (Portage, MI)
- … Affairs (RA) intern at Stryker, you will gain exposure to global regulatory strategy and compliance while working cross-functionally with teams such as ... R&D, Supplier Quality, Marketing, and Clinical Affairs. You will contribute to projects that ensure...will contribute to projects that ensure our products meet regulatory requirements and reach patients safely and effectively: … more
- Dana-Farber Cancer Institute (Boston, MA)
- …the oversight of their disease group's clinical trial portfolio and all related regulatory and compliance requirements. + The ACRM will assist the CRM will ... for assisting with the design, implementation and evaluation of their program's clinical research activities, related regulatory oversight, and will provide day… more
- Hospice of Michigan (Kalamazoo, MI)
- …monitoring and supporting clinical staff, for ensuring quality and compliance with practice standards and regulatory requirements, thereby ensuring that ... with the Five Star Visit model in addition to compliance with clinical standards of practice, ...practice, compliance to policies and procedures, and compliance to regulatory requirements. + Conducts patient… more
- Dana-Farber Cancer Institute (Foxborough, MA)
- …CRC will be responsible for the primary data collection, management of patient clinical information, and regulatory documents as it pertains to participation in ... including shipment to outside entities as required. Maintains site regulatory binders and ensures study compliance with...other Harvard Medical School-affiliated hospitals. + Oversight of the clinical trials regulatory process at the DFCI… more
- Lilly (San Diego, CA)
- … studies that efficiently test therapeutic hypotheses + Collaborate with clinical pharmacology, biostatistics, regulatory affairs, operations, and other ... (biologics, small molecules, cell therapies, genetic medicines) + Knowledge of regulatory requirements for early clinical development (IND strategy, FDA… more
- Abbott (Plano, TX)
- …and exchange of documents between stakeholders (eg, internal personnel such as Regulatory Affairs, R&D Engineering, Clinical Engineering, A&P and Marketing, ... Notified Body questions upon review of submissions. + Provide strategic guidance on regulatory requirements, pertaining to clinical data and clinical … more
- J&J Family of Companies (Irvine, CA)
- …within the Clinical R&D Department to execute and manage company sponsored clinical trials, ensuring compliance with timelines and study milestones for JnJ ... based on study need; + In EMEA, responsible for Regulatory Affairs related tasks associated with clinical ... evidence needs; + May provide on-site procedural protocol compliance and data collection support to the clinical… more
- University of Miami (Miami, FL)
- …of W9 forms. Regulatory Compliance & Documentation + Ensures compliance with Good Clinical Practice (GCP), IRB requirements, and federal regulations. + ... in supporting faculty-led research. In this role, the incumbent will ensure compliance with research standards, regulatory guidelines, and protocols while… more
- J&J Family of Companies (Cincinnati, OH)
- …communication skills and interpersonal relationships + Proven knowledge and experience in clinical research, quality regulatory compliance , adverse event ... junior writers. + Conducting technical reviews to ensure document accuracy and compliance to local procedures, J&J guidelines and regulatory requirements. +… more