- J&J Family of Companies (Irvine, CA)
- …Lead to implement and run company sponsored clinical trials, ensuring compliance with timelines and study milestones, for JJMT Electrophysiology. + ... (eg study protocol, informed consents, CRF, monitoring plan, study manual, investigator brochure, annual reports) with minimal direction. + Ensure trial registration… more
- Sanofi Group (Cambridge, MA)
- …colleagues, Medical Information and Commercial Operations) while maintaining full compliance with relevant company, industry, legal and regulatory requirements + ... reviews, medical and safety evaluation, product positioning, lifecycle evidence planning, and compliance needs. + Contribute to the creation of material for internal… more
- Lilly (Indianapolis, IN)
- …aware of and ensure that all activities of the medical team are in compliance with current local and international regulations, laws, guidance (eg FDA, ICH, CPMP ... ensure appropriate communication of risk to study subjects. + Participate in investigator identification and selection, in conjunction with clinical teams. + Ensure… more
- UNC Health Care (Chapel Hill, NC)
- …regulatory standards. The coordinator functions as a clinician, educator, investigator , consultant, and leader, applying evidence-based practice and clinical ... donor searches, and treatment planning. Oversees outpatient care. 5. **Regulatory Compliance ** Maintains accurate and timely documentation in the electronic medical… more
- Ochsner Health (New Orleans, LA)
- …process to assess toxicities from investigational therapies and works with the investigator in management of these adverse events. + Working knowledge in using ... required. + Uses the nursing process to ensure protocol compliance including but not limited to patient recruitment, engaging...as a liaison for both patient and the private investigator (PI) and monitors patients for safety and adverse… more
- Albany Housing Authority (Albany, NY)
- …AND three (3) years of work experience in a legal, policy or compliance field as a lawyer, law clerk, policy analyst, confidential advisor/assistant, investigator ... not limited to; Local, State and Federal regulatory agency compliance , customer grievances, employee grievances, disciplinary hearings, collective bargaining unit… more
- University of Utah (Murray, UT)
- …control and completion of research studies while assisting the Principal Investigator in determining and accomplishing study objectives. Oversees research studies in ... an administrative and operational capacity while maintaining compliance with guidelines set by governing agencies. **Responsibilities** 1. Oversees compliance to… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …and overseeing complex microbiological testing and environmental monitoring (EM) in compliance with cGMP, USP, FDA, and internal quality standards. This position ... QC department laboratory supplies. + Ensures laboratory equipment is in compliance with procedures and GLP requirements. + Troubleshoots laboratory issues related… more
- Johns Hopkins University (Baltimore, MD)
- …Treatment Plan development for both new submissions and amendments. + Assures compliance with local & national regulatory standards; as appropriate, prepares & ... prior to initiation of research activity. + Represents department at research, investigator and protocol initiation meetings as required. + Assures that all elements… more
- Ochsner Health (New Orleans, LA)
- …research and clinical trials, serving as a liaison for both patient and Principal Investigator (PI). + Serves as primary point of contact for patient to report and ... procedures in accordance with protocol requirements and reports results to the investigator . + Performs clinical laboratory activities as required per protocol and… more