University of Colorado Anschutz Medical Campus

Department: Barbara Davis Center for Diabetes, Pediatric Division

Job Title: Research Services Regulatory Compliance (Entry – Senior) Professional

Position: 00842778– Requisition:38373

Job Summary:

The Barbara Davis Center (BDC) for Childhood Diabetes at the University of Colorado Denver is a multi-disciplinary diabetes center affiliated with the University of Colorado, School of Medicine. The patient population spans the ages 1 to 70 years with either type 1 or type 2 diabetes. The BDC also serves as a clinical center for TrialNet, an international, multi-center research organization with the goal of understanding the pathophysiology of type 1 diabetes as well as finding ways to prevent type 1 diabetes. Additionally we have many treatment and prevention industry sponsored clinical trials for type 1 diabetes. 

The Prevention Team at the Barbara Davis Center is seeking a full-time Regulatory Compliance Lab Coordinator. The Prevention Teams conducts clinical trials for type 1 diabetes prevention and intervention. This position involves coordinating the Pathway to Prevention NIH funded screening program and independently managing the sample processing, shipping and storage of specimens from several NIH funded and industry funded clinical trials.  The person in this position will act as the lead screening study coordinator and coordinate laboratory activities for numerous other trials.

Regulatory Compliance Lab Coordinators provide direct professional support of research activities. Functions include contracts and grant solicitation and administration, grant/agreement preparation, review and negotiation, regulatory compliance, sponsor communication and post and pre award management, human subject compliance, research animal management, research laboratory coordination and instruction, environmental health and safety, radiation control, hazardous materials use, disposal and training.

Key Responsibilities:

• Process human biological samples for multiple clinical research studies including blood centrifugation, aliquoting, preparation, storage, data entry, samples management and shipping, maintaining laboratory compliance to safety regulation.

• Conduct analysis of biological samples to answer research questions: including hemoglobin A1C analysis, urine pregnancy tests, and blood glucose levels.

• Assist with the day-to-day laboratory operations of clinical trials and studies

• Adhere to research regulatory standards

• Maintain detailed records of sample processing to ensure compliance with requirements of the Food and Drug Administration (FDA), study protocols, department, hospital/clinical standard operating procedures and other regulatory guidelines

• Ensure that the necessary supplies and equipment for studies are in stock and in working order

• Independently perform sample processing and management

At the Intermediate Rank, individuals will also be expected to:

• Oversee the day-to-day laboratory operations of clinical