- University of Colorado (Aurora, CO)
- …#:37574** **Job Summary:** Key Responsibilities: + Act as a Primary Coordinator on multiple trials/studies, managing the day-to-day operations. + Develop ... procedures, and assessments as defined in the study protocol and in compliance with regulating bodies. + Assist Team Leads, Supervisors, and/or management with… more
- University of Colorado (Aurora, CO)
- …and patient safety. + Assist with audits, inspections, and reporting for regulatory and compliance entities including FDA , DEA, and COMIRB. + Teach and mentor ... Prepare, compound, and dispense sterile and non-sterile investigational drugs in compliance with state, federal, and regulatory standards. + Collaborate with… more
- University of Colorado (Aurora, CO)
- …teams to ensure safe and efficient investigational drug management + Ensure compliance with FDA regulations, IND requirements, Good Clinical Practice standards, ... particular interest in clinical research, investigational drug management, and regulatory compliance in academic or healthcare settings. + **Excellent written and… more
- University of Colorado (Aurora, CO)
- …scheduling as per Gates Biomanufacturing facilities' standard operating procedure to meet FDA good manufacturing practice (GMP) compliance . + Participate in new ... **Job Summary:** Key Responsibilities: **Project Management, Process Improvement & Regulatory Compliance - 10%** + Evaluate and ensure traceability and status… more
- University of Colorado (Aurora, CO)
- …to research regulatory standards + Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration ( FDA ), study ... and assessments as defined in study protocol and in compliance with regulating bodies + Assist Team Leads, Supervisors...and quality improvement initiatives + Act as a Primary Coordinator on multiple trials/studies + Assist and train junior… more
- University of Colorado (Aurora, CO)
- …forms, and other essential documents for assigned studies. + Maintain compliance with research regulatory standards and NIH subrecipient monitoring plans, including ... management aspects of research projects, including grant management and compliance with fiscal policies. + Experience in preparing and... requirements, such as those set by the NIH, FDA , and IRB. + Ability to coordinate and delegate… more
- University of Colorado (Aurora, CO)
- …documents are filed as required + Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration ( FDA ), study ... laboratory, radiology, pharmacy) + Coordinate and administer patient care in compliance with protocol requirements + Assist with developing or develop… more
- University of Colorado (Aurora, CO)
- …review, maintain regulatory and other program/project documentation + Ensure program/project compliance with Food and Drug Administration ( FDA ) and other ... with Disabilities Act, please contact the Human Resources ADA Coordinator at ###@cuanschutz.edu (https://apptrkr.com/get\_redirect.php?id=6514895&targetURL=###@cuanschutz.edu) . The University of Colorado… more
- University of Colorado (Aurora, CO)
- …analytic and post-analytic variables that reduce efficiency, quality, cost, compliance , and workplace satisfaction. + Participate in clinical pathology on-call ... functioning of multiple laboratories, including providing expert guidance for validating both FDA cleared or approved tests and lab developed tests (LDTs), advising… more
- University of Colorado (Aurora, CO)
- …documents are filed as required. + Maintain detailed records of studies to ensure compliance with requirements of the Food and Drug Administration ( FDA ), study ... with Disabilities Act, please contact the Human Resources ADA Coordinator at ###@cuanschutz.edu (https://apptrkr.com/get\_redirect.php?id=5613530&targetURL=###@cuanschutz.edu) . The University of Colorado… more