Clinical Research Coordinator 1
Hyde Park Campus
2012716 Surgery-Surgical Res.
About the Unit
Since the founding of the Department in 1927, many scientists, including our very own Nobel Prize-winning Charles B. Huggins, MD, have made important discoveries about various diseases and treatment protocols that still serve as a basis for standard clinical practice today. Today, our scientists continue to embody the ethos of the University of Chicago's commitment to open, rigorous, and intense inquiry. Our laboratories tackle some of today's most complex biomedical challenges, including research into immunotolerance, vaccine stabilization and bioengineering. This ongoing work and achievement would not be possible without the cohesive effort of the faculty and staff. We are always looking for individuals who are willing to work in our dynamic and collaborative environment.
The Clinical Research Coordinator 1 (CRC1) works under the general direction of a departmental, clinical research manager and/or the Office of Clinical Research (OCR) in partnership with the Principal Investigator (PI), Co-Investigator(s) and other study personnel. The CRC1 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 CRC1 coordinates, completes and monitors the daily clinical trial or research activities and performs a variety of duties involved in the collection, compilation, documentation and reporting of clinical research data. The CRC1 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:
- Manages all aspects of conducting clinical trials and clinical research studies from startup to closeout for one or two clinical trials. 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 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.
- 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.
- Other duties as assigned.
- 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
- Bachelor's degree required.
- Minimum of 1 year of research experience or relevant experience preferred.
- Cover Letter
- Contact information for at least three supervisory references
NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application
Depends on Qualifications
Scheduled Weekly Hours
Job is Exempt?
Drug Test Required?
Does this position require incumbent to operate a vehicle on the job?
Health Screen Required?
Remove from Posting On or Before
The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, status as an individual with a disability, protected veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
Staff Job seekers in need of a reasonable accommodation to complete the application process should call 773-702-5800 or submit a request via Applicant Inquiry Form.
The University of Chicago's Annual Security & Fire Safety Report (Report) provides information about University offices and programs that provide safety support, crime and fire statistics, emergency response and communications plans, and other policies and information. The Report can be accessed online at: http://securityreport.uchicago.edu. Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.
The University of Chicago is an urban research university that has driven new ways of thinking since 1890. Our commitment to free and open inquiry draws inspired scholars to our global campuses, where ideas are born that challenge and change the world.
We empower individuals to challenge conventional thinking in pursuit of original ideas. Students in the College develop critical, analytic, and writing skills in our rigorous, interdisciplinary core curriculum. Through graduate programs, students test their ideas with UChicago scholars, and become the next generation of leaders in academia, industry, nonprofits, and government.
To learn more about the university click here http://www.uchicago.edu/