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Research Instructor - Aurora Colorado
Company: University of Colorado Anschutz Medical Campus Location: Aurora, Colorado
Posted On: 01/27/2025
Research Faculty Description University of Colorado Anschutz Medical Campus Department: Anesthesiology Job Title: Research Instructor Position #00600002: - Requisition #:34579 Job Summary: The Research Instructor in the iC42 Clinical Research and Development group is a hands-on individual responsible for the group's clinical trials strategic initiatives. Such responsibilities include developing program/project goals and communicating goals, progress, and outcomes with a variety of stakeholders; participating in tactical and strategic program/project development and planning, including managing strategic infrastructure and resource, strategic collaborations, organization of collaboration among sites, site training and education, quality control, risk assessment, developing milestone, deliverables, managing scope, and delivering the scope on-time and on budget. The Research Instructor will coordinate, administer, organize and document all of iC42 Clinical Research and Development's clinical trials operations and therefore manage all relevant communications with the Clinical Investigators, Laboratory Director, Administration, Quality Assurance, IRB, University of Colorado Regulatory Affairs and Compliance, the Colorado Clinical Translational Sciences Institute including its clinical trials services and Regulatory Knowledge and Support group, software programmers, IT, database managers, clinical sites and sponsors. The Research Instructor will manage and supervise all aspects of the day-to-day operations of iC42 Clinical Research and Developments clinical trials operations. The individual will also carry out these processes. Given their oversight of clinical and laboratory research staff, the position is responsible for the development and maintenance of standard operating procedures, and training of personnel, and implementation. Moreover, this position is also responsible for the recruitment of personnel in collaboration with the Department of Anesthesiology's Administration and Human Resources. Key Responsibilities: Contribute to clinical trial design and protocol writing which will also include Site visits, inspections, CRF, database audits, resolution of queries and corrective actions Communication with the regulatory team and assistance in FDA IND and IRB submissions Clinical trials advertisement and recruiting as well as registration, maintenance and update of ClinicalTrial.gov entries Communicating with participants regarding study objectives through obtaining written consent/ assent Collecting data obtained from research, coding and analyzing it. This includes the design and setup of eCRFs, data entry and review in electronic clinical trials system such as REDCap Design, oversight over the preparation, documentation and quality control of sample collection kits as well as making sure that all equipment and supplies needed for the study are in-stock and in good working order Sample collection (e.g. blood draws), sample processing and analysis Work Location: Onsite - this role is expected to work onsite and is located in Aurora, Colorado. Why Join Us: iC42 Clinical Research & Development is a cutting-edge bioanalytical resource and Service Center at the University of Colorado as well as a CU Medicine site of clinical practice. iC42 Clinical Research and Development provides clinical toxicology and therapeutic drug monitoring and carries out its own clinical trials, in collaboration with the biotech/ pharmaceutics industry and academic collaborators. iC42 Clinical Research and Development has a CAP/CLIA accredited laboratory with 17 LC-MS/MS systems, a pharmacokinetics/ pharmacokinetic modeling group, quality assurance unit and a clinical toxicology laboratory, serves as a central laboratory for multi-center clinical trials and is set up to run clinical trials including design, protocols, coordination and conduct, pharmacokinetics/ toxicokinetics, statistical analysis to reporting. The University of Colorado offers a comprehensive benefits package that includes health insurance, life insurance, retirement plans, tuition benefits, ECO pass, paid time off - vacation, sick, and holidays and more. To see what benefits are available, please visit: . Diversity and Equity: The University of Colorado Anschutz Medical Campus is committed to recruiting and supporting a diverse student body, faculty and administrative staff. The university strives to promote a culture of inclusiveness, respect, communication and understanding. We encourage applications from women, ethnic minorities, persons with disabilities, persons within the LGBTQ+ community and all veterans. The University of Colorado is committed to diversity and equality in education and employment. Qualifications: Minimum Qualifications: Applicants must meet minimum qualifications at the time of hire. Master's degree in a medical field such as nursing 5 years of documented experience in clinical trials management, coordination and/ or as a research nurse Certification as phlebotomist Preferred Qualifications: |
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