Research Services Regulatory Compliance (Entry - Senior) Professional

University of Colorado•Aurora, CO

37d•Onsite

About The Position

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.

Requirements

A bachelor's degree in science, or a directly related field from an accredited institution
A bachelor's degree in science, or a directly related field from an accredited institution
1 (one) year relevant clinical research experience
A bachelor's degree in science, or a directly related field from an accredited institution
2 (two) years relevant clinical research experience
Substitution: A combination of education and related technical/paraprofessional experience may be substituted for the bachelor's degree on a year-for-year basis.
Applicants must meet minimum qualifications at the time of hire.
Ability to communicate effectively, both in writing and orally.
Ability to establish and maintain effective working relationships with employees at all levels throughout the institution.
Outstanding customer service skills.
Demonstrated commitment and leadership ability to advance diversity and inclusion.
Knowledge and understanding of federal regulations related to human subject research and Good Clinical Practice
Team-oriented, self-motivated and able to work independently
Excellent organizational and time management skills

Nice To Haves

Experience recruiting and consenting for human subject's research
Experience processing biological specimens

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
Oversee the day-to-day laboratory operations of clinical trials and studies
Perform informed consent process or ensures that the informed consent process has occurred, is properly documented, and that informed consent form documents are filed as required.
Schedule subject participation in research study or clinical trial, coordinating availability of necessary space and clinical research support (e.g, physician, nurse practitioner, laboratory, radiology, pharmacy)
Obtain study subject's medical history and current medication information, reviews research protocol inclusion/exclusion criteria and confirms eligibility of subject to participate in clinical trial
Independently master study materials, including but not limited to protocols, informed consent forms, and all other essential study documents for assigned studies.
Independently perform study related processes, procedures, and assessments as defined in study protocol and in compliance with regulating bodies

Benefits

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: https://www.cu.edu/employee-services/benefits-wellness.
Your total compensation goes beyond the number on your paycheck. The University of Colorado provides generous leave, health plans and retirement contributions that add to your bottom line.

Stand Out From the Crowd

Upload your resume and get instant feedback on how well it matches this job.

Upload and Match Resume