- Gilead Sciences, Inc. (Foster City, CA)
- …monitoring, including but not limited to assessment of eligibility criteria, addressing investigator questions, safety monitoring, and ensuring high data quality ... scientific and clinical leadership or oversight in the preparation of investigator brochures + Provide scientific and clinical leadership to cross-functional teams… more
- Parexel (Atlanta, GA)
- …for the site management, site monitoring and close-out of assigned clinical trials investigator sites to ensure patient safety and quality study execution in ... trials (eg enrollment, database release), to safeguard the quality of investigator sites (eg patient safety , site quality and compliance with GCP), to maintain … more
- Rush University Medical Center (Chicago, IL)
- …to the regulatory aspects of clinical research. * May coordinate timely investigator assessment of safety reports. * Proactively identifies regulatory issues ... studies, single site studies, intergroup studies, industry studies, and investigator initiated studies. Prepares internal and external regulatory submissions… more
- Colliers Engineering & Design (Phoenix, AZ)
- …members and report progress and/or any issues to Field Director or Principal Investigator . + Conduct daily safety tailgate meetings. + Pre-plan upcoming survey ... crew is prepared for the day including tasks such as required equipment, daily safety briefing or log has been addressed, team members are working at the appropriate… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Investigational New Drug (IND), IND amendment, and routine submissions (eg, Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.). ... + Leads cross-functional teams in the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc. + Provides input to the content of the original label and label updates. + Ensures product packaging and associated… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Investigational New Drug (IND), IND amendment, and routine submissions (eg, Development Safety Update Reports / DSURs, Investigator Brochure/ IB updates, etc.). ... + Oversees and approves the authoring of regulatory documents, including meeting requests, Module 1 documents for original IND, etc. + Oversees and guides labeling, packaging and associated information updates and maintenance in accordance with the product… more
- Texas A&M University System (College Station, TX)
- …laboratory supplies and maintain inventory. .Maintain laboratory equipment. .Oversee laboratory safety . .Assist the principal investigator and other laboratory ... methods with preparing reports, figures, invoices, cataloging records and other documents. .Other duties and tasks as assigned. -Assists undergraduate and/or graduate students and other laboratory, technical or field staff involved in research. Required… more
- Regeneron Pharmaceuticals (Tarrytown, NY)
- …aspects of trial - Assist with medical monitoring, raising and responding to investigator queries, writing safety narratives, analysis of trends of safety ... documents such as: regulatory agency briefing books, IND/IMPD submissions, investigator 's brochure, informed consent forms, IRB/IEC submissions, clinical study… more
- Kelly Services (South San Francisco, CA)
- …ECG, and concomitant medications; and maintain a medical decision log. + Represent safety during Site Initiation Visits, Investigator Meetings, CROs ,and other ... The Director, Pharmacovigilance is responsible for leading global drug safety activities, ensuring compliance with regulatory requirements for adverse event… more
- Adecco US, Inc. (Fairfax, VT)
- …etc. * Develop and implement motivational programs that promote a high degree of safety awareness. * Serve as the investigator on all work-related injuries and ... scale:** $60K to $70K **Required** : Bachelor's Degree (BS) in Occupational Safety and Health, Environmental Management or equivalent experience. Minimum of two… more