University of Chicago Senior Clinical Research Center Coordinator in Chicago, Illinois
About the Unit
The University of Chicago was awarded a Clinical and Translational Science Award (CTSA) by the National Institutes of Health, National Center for Advancing Translational Sciences (NCATS) to provide resources to basic, clinical, and translational scientists through new professional interactions, program and research projects, and through the elimination of barriers within research. The Institute for Translational Medicine (ITM) is the administrative unit for UChicago's CTSA program, and it works with more than 60 institutions across the country as part of the CTSA consortium to advance medicine in innovative ways and transform research results into improved clinical practice. The ITM operates across divisional, departmental, and professional school lines to generate new research methods, technologies, and molecular target discovery. It also works with its affiliates at Rush University Medical Center, the Illinois Institute of Technology (IIT), and NorthShore University HealthSystem, along with strategic Chicagoland partner organizations and community members to convert biomedical research into health improvement and to raise public awareness both about the research being done and the importance of participation in clinical trials.
Unit Job Summary
The Senior Clinical Research Center Coordinator (SCRCC) is a highly specialized research professional partnering with the ITM Associate Director for the Hub Research Capacity Cluster, study Principal Investigators (PI), Co-Investigators, departments, sponsoring agencies, and/or the Office of Clinical Research. The Senior CRC has full autonomy over the daily administrative and technical activities in highly complex, large, nationwide or multiple moderately complex and concurrent clinical trials involving multiple sites and/or longitudinal assessments/interventions. This role ensures that all activities are completed by strictly following Good Clinical Practices (GCP) and all relevant current local, state, and federal laws, regulations, guidance, policy and procedure developed by the Institutional Review Board (IRB), Food and Drug Administration (FDA) and Code of Federal Regulations (CFR).
The Senior CRC develops, manages, and reports on key data; ensures timeliness of data and reporting submissions from multiple investigators; and, establishes and implements consistent standards and protocols. This role is responsible for preparing and coordinating internal and external audits; coordinating external surveys; and, participating in periodic study meetings/teleconferences.
The Senior CRC trains/mentors study teams using the HRC Cluster of the ITM on the basics of clinical research, Good Clinical Practice (GCP), Good Documentation Practices (GDP), Standard Operating Procedures (SOPs) and other related aspects of the clinical study. The Senior CRC acts as an advocate for junior clinical research staff by communicating needs and identifying and resolving issues that arise, and identifies staff development needs and provides in-services to staff.
The Senior CRC may assist in developing and executing strategic and operational plans for clinical research within a department/unit.
Bachelor's degree required.
Minimum of 5 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials) required. Experience coordinating multiple and a variety of studies (e.g., investigator initiated, industry sponsored, multi-site trials) required.
Ability to train junior CRCs required. Ability to participate in protocol review and clinical trials evaluations required. Excellent interpersonal skills required. Strong data management skills and attention to detail required. Ability to handle competing demands with diplomacy and enthusiasm required. Ability to work collaboratively with faculty and divisional clinical research infrastructure required. Excellent time management and ability to prioritize work assignments required. Ability to read and understand clinical trials protocols required. Familiarity with medical terminology/environment required. Working knowledge of Good Clinical Practices (GCP) required. Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat required.
Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance) preferred.
Required Job Seeker Documents
Resume Cover Letter
Optional Job Seeker Documents
Requisition Number: 103137
Departmental Job Title: Senior Clinical Research Center Coordinator
Type of Position: Staff
Number of Positions Available: 1
Division: Biological Sciences
Department: 2010014-BSD-Clinical & Translational Science Award
Work Location: Campus - Hyde Park
Work Schedule: Full-Time
If other than regular hours (M-F, 8:30-5:00) please detail: Flexible Hours, Occasional evening, night or weekend hours may be needed.
Benefits Eligible?: Yes
Union (If applicable): Non-Union
Pay Grade: NA
Pay Range: Depends on Qualifications
Pay Frequency: Monthly
Does this position require incumbent to operate a vehicle on the job?: No
Is a Background Check Required?: Yes
Is Drug Testing Required?: Yes
Employee Referral Bonus Amount: None
Posting Date: 07-17-2017
Remove from posting on or before: 01-17-2018