Clinical Research Center Coordinator
Hyde Park Campus
2010014 BSD - CTSA
About the Unit
The University of Chicago (UC) Institute for Translational Medicine (ITM) was created in 2007 to assemble, integrate, and create the intellectual, administrative, and physical resources required to catalyze research and research training in Clinical and Translational Science. Its ultimate goals are to train scientists and health care providers at UC and in our community to determine the molecular, genetic, pathophysiologic, and social determinants of disease and disease predisposition in individuals; to test interventions directed toward those mechanisms; and to achieve these goals in a way that is rigorous, efficient, ethical, respectful of, and responsive to our community's needs and values. Over its nine years, the ITM has capitalized on the outstanding intellectual and physical resources throughout the University and at ITM affiliate Institutions, Argonne National Laboratory, NorthShore University HealthSystem, Illinois Institute of Technology, and Access Community Health Network, and on substantial institutional and CTSA financial investments, to build the infrastructure for a transformative, energized, and self-improving home for clinical and translational research, ensuring the continued progress of clinical and translational science at the University of Chicago, its affiliates, on the South Side of Chicago, and beyond.
The Clinical Research Center Coordinator works under the general direction of the Clinical Research Center Director in partnership with CRC Principal Investigators (PIs), Co-Investigator(s) and other study personnel. The CRCC works with the PI, clinical research manager, department, sponsoring agencies, and the OCR to support and provide guidance on the administration of the compliance, financial, and other related aspects of the clinical study. The CRCC coordinates, completes and monitors the daily clinical trial activities and performs a variety of duties involved in the collection, compilation, documentation and reporting of clinical research data. The CRCC plays a critical role in ensuring compliance with the study protocol, Federal guidelines, Local guidelines, and in accordance with Good Clinical Practice (GCP).
Research Conduct/Study Management:
- Assists the study team with all aspects of conducting clinical trials from startup to closeout for the studies that use the CRC. Responsibilities include, but are not limited to, recruitment and screening of study subjects, obtaining informed consent, enrollment of subject in research study, subject follow-up, collecting and analyzing research data, completion of the case report form (CRF), adverse event reports and ensuring protocol adherence.
- Plans and coordinates subjects schedule for study procedures, return visits, and study treatment schedules; educates subjects about study procedures to be performed, what to report between and during visits, and the risks and benefits of the procedures; performs assessments at visits and monitors for adverse events.
- Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
- Independently performs assessments to monitor for and identify adverse events and protocol deviations or violations, and assists PI in reporting to the sponsor and IRB under general direction of department, clinical research manager and/or the Office of Clinical Research.
- Reviews the protocol plan to understand and assist with feasibility evaluation and planning for the various costs and resources required such as clinical care expenses, personnel effort, site initiation costs (IRB fees, pharmacy costs, etc.), equipment, and supplies.
- Monitors recruitment and identifies studies at risk for not meeting timelines and milestones.
- Organizes and actively participates in site visits from sponsors and other relevant study meetings.
- Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.
- Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol. Responsibilities include, but are not limited to, provides efficient and complete data collection, processing, analysis and reporting; assures source documentation and data abstraction and entry are being done at the protocol specified time-points; ensures data accuracy and integrity by working closely with internal monitors and/or auditors to promptly resolve any data quality concerns or outstanding queries; and, facilitates the exchange of data across projects and organizations.
- Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.
- Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.
- Maintains accurate and complete records which may include, but are not limited to, signed informed consent, Institutional Review Board (IRB) communication, source documentation, CRFs, drug dispensing logs, and study related communication.
- May prepare and maintain protocol submissions and revisions.
- Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others required.
- Ability to communicate with tact and diplomacy required.
- Strong organizational skills required.
- Strong communication skills (verbal and written) required.
- Excellent interpersonal skills required.
- Strong data management skills and attention to detail required.
- Knowledge of Microsoft Word, Excel and Adobe Acrobat required.
- Ability to read and understand complex documents (e.g., clinical trials) required.
- Ability to handle competing demands with diplomacy and enthusiasm required.
- Ability to absorb large amounts of information quickly required.
- Adaptability to changing working situations and work assignments required.
- Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines preferred.
- Knowledge of medical terminology / environment preferred
- Understanding of the IRB submission and review process and when and how to apply for IRB review preferred
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation preferred
The above information on this description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities and qualifications required of employees assigned to this job.
Education, Experience and Certifications:
- Bachelor's degree required.
- Minimum of 1 year of research experience or relevant experience preferred.
- Direct contact with research participants in a clinical care setting. Exposure to biological fluids and samples. Exposure to infectious material. Standard office environment as well.
- Ability to bend, crouch, lift, or stoop.
- Cover letter
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualification
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
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