- Independently prepare, develop, and submit Institutional Review Board (IRB), Biosafety, and Research and Development Committee documents such as protocols for initial submissions, protocol amendments, and continuing reviews for both human subject research protocols and bench studies.
- Route Data Use Agreements, Material Transfer Agreements, Research Collaboration Agreements, and other clinical agreements for full execution and monitors progress following up as needed.
- Responsible for preparing, maintaining, and updating regulatory binders for review by internal or external monitoring/auditing groups.
- Maintain current and accurate records of all applicable training and associated documents (CITI GCP, GLP, CVs, Licenses, etc.) for all research staff.
- Serve as CAMM point of contact and coordinator for the development of new clinical protocols as well as point of contact for clinical trial sites and study sponsors to develop laboratory manuals, training materials, Standard Operating Procedures (SOP), and other material related to the collection, processing, storage, and intake of CAMM related biomarker samples collected in these studies.
- Conduct training on sample collection methods, processing, and storage for clinical trial sites.
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Research and Regulatory Coordinator - Florence, United States - University of Colorado
Description
Research and Regulatory Coordinator (Entry – Senior Level)-33673University Staff DescriptionUniversity of Colorado Anschutz Medical Campus
School of Medicine | Department of Medicine | Division of Pulmonary Sciences and Critical Care
Job Title: Research and Regulatory Coordinator (Entry – Senior Level)
Position: # – Requisition: #33673
Job Summary:
The Consortium for Applied Microbial Metrics ) is a multi-institutional collaboration of investigators with a shared goal: to develop new pharmacodynamic (PD) markers that will accelerate pre-clinical drug development and human trials in mycobacterial diseases, including tuberculosis (TB) and non-tuberculosis lung disease. As a platform for cross-disciplinary collaborative innovation, the Consortium is developing practical new solutions to accelerate drug and regimen development for tuberculosis and other mycobacterial diseases. The Consortium is committed to the highest standards in research reproducibility and transparency. The Consortium is in a phase of rapid growth as key not-for-profit, federal and pharma stakeholders seek to utilize our novel drug-evaluation tools.
The CAMM Molecular Core, under the guidance of PI Dr. Nichoals Walter and Associate Director for Operations is seeking a full-time Research and Regulatory Coordinator whose primary responsibility is to serve as the primary point of contact for the CAMM Molecular Core to interface with clinical trial sites and manage the regulatory process of the CAMM Molecular Core lab for clinical protocols.
Note: This position is not anticipated to have any patient contact.
Key Responsibilities:
Work Location:
Hybrid – this role is eligible for a hybrid schedule and as needed for in-person meetings; onsite location is at the Anschutz Medical Campus in Aurora, Colorado and schedule will be coordinated with supervisor.
Why Join Us
