Clinical Research Center Coordinator

Job Description:

Unit-specific Responsibilities

1) 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).

 2) 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, cohort discovery, 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.

3) Uses IT tools to search data warehouses and registries to determine possible cohort size and identify potential participants for recruitment.

4) 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.

5) Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.

6) 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.

7) 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.

8) Monitors recruitment and identifies studies at risk for not meeting timelines and milestones.

9) Organizes and actively participates in site visits from sponsors and other relevant study meetings.

10) Maintains a safe research environment and ensures compliance with governmental and University policies, procedures and regulations.

11) Controls the acquisition/collection, abstraction, processing, privacy, and quality assurance for all clinical research data required for the protocol.

12) 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.

13) Protect patient and data confidentiality by ensuring security of research data and protected health information (PHI) and compliance with federal regulations and sponsor protocols.

14) Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, PI, and regulatory agency specifications.

15) 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.

16) May prepare and maintain protocol submissions and revisions.

Unit-preferred Competencies

1) Ability to interact and communicate with clarity, tact, and courtesy with patrons, patients, staff, faculty, students, and others.

2) Ability to communicate with tact and diplomacy required. Strong organizational skills.

3) Strong communication skills (verbal and written) required. Excellent interpersonal skills.

4) Strong data management skills and attention to detail required. Knowledge of Microsoft Word, Excel and Adobe Acrobat.

5) 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.

6) Adaptability to changing working situations and work assignments required.

7) Knowledge of patient evaluation and triage procedures and the ability to monitor clinical research patients from many disciplines.

8) Knowledge of medical terminology / environment.

9) Understanding of the IRB submission and review process and when and how to apply for IRB review.

10) Understanding of the federal research regulations and the ability to identify the federal research organizationsâ™ role in regulating human research participation.

Preferred Qualification

Education

1) Bachelorâ™s degree

Required Documents

1) Cover Letter

2) Resume

NOTE: When applying, all required documents MUST be uploaded under the Resume/CV section of the application

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 the 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: 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.