BSD PED - Clinical Trials Office
About the Department
In the Department of Pediatrics at the University of Chicago, we strive to provide the highest level of complex care for children from diagnosis and treatment to conducting research to find promising new therapies with a focus on teaching. We are committed to advancing the frontiers of knowledge, and the education and training of future clinical pediatricians, subspecialists, educators, clinical investigators and physician-scientists. The Department of Pediatrics is a dynamic, stimulating place to work, and because we are focused on growth and improved excellence, our staff have particularly challenging and rewarding roles.
The Pediatric Clinical Trials Office (Peds CTO) is an existing centralized support office that provides services and high level guidance to individuals (faculty, investigators, research staff, and clinic coordinators from the University and Hospital) involved in human subjects research. The Peds CTO is responsible for establishing standards, operating procedures, policies and practices, implementing educational and training programs, developing communication tools, and managing the administrative functions that impact individuals involved in clinical research.
The Senior Pediatric Clinical Research Coordinator provides support to the section of Neonatology within the Department of Pediatrics in the Biological Sciences Division. The Sr CRC will be involved in multiple research trial types: investigator initiated, multi-centered cooperative group studies, multi-institutional pharmaceutical trials, and multi-centered trials designed, implemented and coordinated in the Section. The Senior Pediatric Clinical Research Coordinator is a specialized researcher partnering with the Principal Investigator (PI) and under the direction of a departmental research manager. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the Sr CRC supports, facilitates and coordinates independently the daily clinical research activities and plays a critical role in the conduct of the study. The Sr CRC also oversees other clinical research coordinators within the Pediatric Clinical Trials Office. By performing these duties with limited supervision and/or guidance, the Sr CRC works with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.
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.
This at-will position is wholly or partially funded by contractual grant funding which is renewed under provisions set by the grantor of the contract.Employment will be contingent upon the continued receipt of these grant funds and satisfactory job performance.
- Acts as a liaison with medical staff, university departments, ancillary departments and/or satellite facilities.
- Serves as a resource person or acts as a consultant within area of clinical expertise.
- Acts as a leader within the department/unit through improving clinical research practice and serving as a resource.
- Maintain working knowledge of current protocols and internal SOPs.
- Be accountable for high standards of clinical research practice and assist in the development of accountability in others.
- Develops and implements procedures, maintain records, tracks progress, and conducts quality assurance on data collected.
- Oversees and participates in the coordination and conduct of complex clinical research studies and ensures compliance with federal and institutional regulations.
- Prepares, submits, and assists Investigators with multiple levels of research documentation (i.e. IRB submissions, educational materials, reports, grant renewal reports, and study forms).
- Provides Investigators with guidance regarding protocol requirements.
- Maintains regulatory documentation.
- Assists other research personnel with reports to regulatory agencies, such as the IRB, FDA and Data and Safety Review Committee.
- Provides direct supervision of other clinical research staff (i.e. hiring/firing, performance evaluations, disciplinary actions, approve time off, etc.), or assist.
- Attends continuing education and training opportunities relevant to job duties.
- Manages all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
- Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.
- Analyzes, facilitates and participates in the daily activities of multiple moderately complex clinical trials and performs all aspects of clinical data management, including patient data retrieval, referring MD office records, preparing clinical research charts, and participation in program audits.
- Prepares program conference lists for multidisciplinary conferences and workshops. Participates in all pharmaceutical site visits. Uses moderate understanding of clinical trials to collect and store patient specimens, radiology scans and reports.
- Solves a range of straightforward problems relating to the administration of the compliance, financial and other related aspects of a clinical study.
- Performs other related work as needed.
Minimum requirements include a college or university degree in related field.---
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.---
Licenses and Certifications:
- 5 years of clinical research experience coordinating multiple and variety of studies (e.g., investigator initiated; industry sponsored; multi-site trials).
- Experience overseeing staff.
- Research certification (e.g., SoCRA, ACRP, Graham School Clinical Trials Management & Regulatory Compliance).
- Ability to train junior CRCs.
- Ability to participate in protocol review and clinical trials evaluations.
- Excellent interpersonal skills.
- Strong data management skills and attention to detail.
- Ability to handle competing demands with diplomacy and enthusiasm.
- Ability to work collaboratively with faculty and divisional clinical research infrastructure.
- Excellent time management and ability to prioritize work assignments.
- Ability to read and understand clinical trials protocols.
- Familiarity with medical terminology/environment.
- Working knowledge of Good Clinical Practices (GCP).
- Extensive knowledge of Microsoft Word, Excel and Adobe Acrobat.
- Ability to communicate in writing.
- Ability to communicate orally.
- Ability to comprehend technical documents.
- Understanding of the federal research regulations and the ability to identify the federal research organizations' role in regulating human research participation.
- Ability to develop and manage interpersonal relationships.
- Ability to exercise absolute discretion regarding confidential matters.
- Ability to follow written and/or verbal instructions.
- Ability to give directions.
- Ability to handle sensitive matters with tact and discretion.
- Ability to handle stressful situations.
- Ability to learn and develop skills.
- Ability to maintain a high level of alertness.
- Ability to pay attention to detail.
- Ability to perform multiple tasks simultaneously.
- Ability to prioritize work and meet deadlines.
- Ability to react effectively, quickly, calmly, and rationally during conflicts and emergencies.
- Ability to train or teach others.
- Ability to work effectively and collegially with little supervision or as member of a team.
- Ability to work independently.
- Resume (required)
- Cover Letter (required)
When applying, the document(s) MUST
be uploaded via the My Experience
page, in the section titled Application Documents
of the application.Job Family
Individual ContributorFLSA Status
MonthlyScheduled Weekly Hours
YesDrug Test Required
YesHealth Screen Required
YesMotor Vehicle Record Inquiry Required
Employees must comply with the University's COVID-19 vaccination requirements. More information about the requirements can be found on the University of Chicago Vaccination GoForward.
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.
We seek a diverse pool of applicants who wish to join an academic community that places the highest value on rigorous inquiry and encourages a diversity of perspectives, experiences, groups of individuals, and ideas to inform and stimulate intellectual challenge, engagement, and exchange.
All offers of employment are contingent upon a background check that includes a review of conviction history. A conviction does not automatically preclude University employment. Rather, the University considers conviction information on a case-by-case basis and assesses the nature of the offense, the circumstances surrounding it, the proximity in time of the conviction, and its relevance to the position.
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.
This job has expired.