Clinical Research Coordinator 1 - Pediatrics
University of Chicago
Department
BSD PED - Clinical Trials Office: Allergy and Immunology
About the Department
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.
Job Summary
This at-will position is wholly 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.
Responsibilities
Aliquot and prepare experimental and clinical samples for freezing.
Ensures accurate storage for all specimen types, including blood and plasma samples.
Coordinates all aspects of conducting clinical trials including: screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
Recruit and interview potential study patients with guidance from PI and other clinical research staff.
Maintains accurate and complete documentation of signed informed consent, relevant IRB approvals, source documentation, Case Report Forms (CRF's), and study-related communication.
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
Perform experiments, collect, analyze, and interpret data under the supervision of the PI or designee.
Ensures Standard Operating Procedures (SOP) are implemented and documented in accordance with study sponsor, primary investigator, and regulatory agency specifications.
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and potential side effects.
Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
Understand the IRB submission and review process and when and how to apply for IRB review, including facilitation of study initiation through meticulous and timely preparation of IRB submissions independently.
Coordinate the conduct of the study from startup through closeout including recruitment and screening of study subjects, obtaining informed consent, collecting research data, and ensuring protocol adherence.
Assist with preparation and attend group intervention sessions.
Assist with goal setting of step goals via text-messaging through iCardia platform.
Facilitate accelerometer initialization and distribution for participants at all sites.
Follow-up with participants regarding accelerometer data collection and returning devices.
Assist with downloading accelerometer data using ActiLife software.
Set up Fitbit accounts at each site.
Charge Fitbits prior to distribution.
Troubleshoot Fitbit syncing issues and replace lost or malfunctioning Fitbits.
Monitor weekly steps, last time synced and Fitbit battery level of intervention participants.
Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
Ensures compliance with federal regulations and institutional policies.
Prepares for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups.
Participates in study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
Plans and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
Educates patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
Performs assessments at visits and monitors for adverse events.
Organizes and attends site visits from sponsors and other relevant study meetings.
May prepare and maintain protocol submissions and revisions.
May assist in the training of new or backup coordinators.
Performs various aspects of clinical research, such as collecting and processing specimens, interviewing subjects, taking vital signs, and contributing to the case report.
Analyzes study-related documentation, such as protocol worksheets, procedural manuals, adverse event reports, institutional review board documents, or progress reports.
Accountable for all tasks in basic clinical studies.
Assists with various professional, organizational, and operational tasks under direct supervision.
Uses knowledge of clinical studies to coordinate the collection of analyzable clinical research data and/or samples.
Performs other related work as needed.
Minimum Qualifications
Education:
Minimum requirements include a college or university degree in related field.
Work Experience:
Certifications:
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Preferred Qualifications
Education:
Bachelor’s degree.
Experience:
1-year clinical research experience or relevant experience.
Preferred Competencies
Experience with basic laboratory techniques including centrifuging, aliquoting, measuring, pipetting, labeling, storing, and shipping.
Ability to communicate in writing.
Ability to communicate orally.
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 handle sensitive matters with tact and discretion.
Ability to handle stressful situations.
Ability to learn and develop skills.
Ability to pay attention to detail.
Ability to perform multiple tasks simultaneously.
Ability to prioritize work and meet deadlines.
Ability to work effectively and collegially with little supervision or as member of a team.
Ability to work independently.
Strong data management skills and attention to detail.
Knowledge of Microsoft Word, Excel, and Adobe Acrobat.
Ability to read and understand complex documents (e.g., clinical trials).
Ability to handle competing demands with diplomacy and enthusiasm.
Ability to absorb large amounts of information quickly.
Application Documents
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
Role Impact
Scheduled Weekly Hours
Drug Test Required
Health Screen Required
Motor Vehicle Record Inquiry Required
Pay Rate Type
FLSA Status
Pay Range
The included pay rate or range represents the University’s good faith estimate of the possible compensation offer for this role at the time of posting.
Benefits Eligible
The University of Chicago offers a wide range of benefits programs and resources for eligible employees, including health, retirement, and paid time off. Information about the benefit offerings can be found in the Benefits Guidebook.
Posting Statement
The University of Chicago is an equal opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, or expression, national or ethnic origin, shared ancestry, age, status as an individual with a disability, military or veteran status, genetic information, or other protected classes under the law. For additional information please see the University's Notice of Nondiscrimination.
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.
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.
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