Pediatric Clinical Research Coordinator 1 - Chicago, United States - University of Chicago

Description

Department
BSD PED - Clinical Trials Office
About the Department
The Department of Pediatrics at the University of Chicago is a dynamic and stimulating place to work.

We strive for the highest level of complex care for children from diagnosis and treatment; provide outstanding education and training for students, postgraduate scholars, and physicians; and nurture the research of Department scholars who seek to elucidate the causes of pediatric disease and identify promising new therapies.

In addition to our provision of clinical care at UChicago Medicine (UCM) Comer Children's Hospital and at our regional sites, we are currently expanding our clinical care across Northern Illinois and Northwestern Indiana.

In collaboration with our partners in the Chicagoland Children's Health Alliance (CCHA; Advocate Children's Hospital, and NorthShore University Health System).

CCHA has responsibility for the care of almost 1 million children. The
Department has 6 ambulatory sites and 3 inpatient sites of care across the region with the goal of providing care 'close to home' whenever feasible ).

Our mission is to improve the health of every child entrusted to us, in an inclusive environment that is committed to family-centered care, clinical excellence, impactful scholarship, effective disease prevention, and advocacy for the appropriate care of every child.

We are especially committed to the children on the South Side of Chicago and to altering the inequities in healthcare.

The Department of Pediatrics has approximately 185 physicians, physician-scientists, and scientists in 15 sections that cover the range of pediatric care.

Our education program serves the students of the College, the Pritzker School of Medicine (PSOM), 70 categorical pediatric residents, 6 child neurology residents, 58 fellows, and numerous graduate students and post-doctoral fellows.

The Department has a staff of 220 advanced practice providers, administrators, research administrators, clinical research associates, and laboratory staff.

The Department has an expanding portfolio of Federal, foundational, and Philanthropic awards, and is committed to doubling its research base in the next three years.

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 Center for the Science of Early Trajectories (SET) is composed of a diverse network of basic scientists, physician scientists, and clinicians working collaboratively to transform infant development research and establish a biologic map of the development of pre- and neonatal infants.

Preterm infants are at risk for poor neurodevelopmental outcome due to their degree of prematurity, hospital course, and home environment.

The SET Center, alongside the Claud Lab, studies the changes in the bacterial colonization patterns of these infants in the context of their home environment and to identify a potentially modifiable factor that may influence brain development and thus ensure school readiness for these vulnerable infants.

Job Summary

The Pediatric Clinical Research Coordinator (CRC) 1 provides support to the preterm infant and microbiome studies within the SET Center within the Department of Pediatrics.

The Clinical Research Coordinator 1 works under the general direction of the PI and leadership within the Pediatric Clinical Trials Office, in accordance with established institutional policies and laboratory procedures.

This is an entry-level position with a focus on molecular biology and microbiome research of the preterm infant. Additional responsibilities may include other tasks related to research based on the skills and interests of the candidate. Spanish fluency is preferred.

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.
Our department follows a hybrid work structure that fosters productivity, collaboration, and employee well-being. Working from the office is encouraged for tasks that require a high degree of collaboration.
Responsibilities

• Aliquot and prepare experimental and clinical samples for freezing.
• Ensures accurate storage for all specimen types, including fecal or microbiome 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 to 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.
• 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.
• Performs other related work as needed.

Minimum Qualifications

Education:

Minimum requirements include vocational training, apprenticeships or the equivalent experience in related field (not typically required to have a four-year degree).

* Work

Experience:
Minimum requirements include knowledge and skills developed through 2-5 years of work experience in a related job discipline.
* Certifications:* Preferred Qualifications

Education:

• Bachelor's degree.

Experience:

• 1-year clinical research experience or relevant experience.

Preferred Competencies

• Professional working proficiency in Spanish.
• 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.

Working Conditions

• Eligible for hybrid work based on business needs and the demands of specific tasks. Working from the office is encouraged for tasks that require a high degree of collaboration.

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
Research
Role Impact
Individual Contributor
FLSA Status
Non-Exempt
Pay Frequency
Biweekly
Scheduled Weekly Hours
40
Benefits Eligible
Yes
Drug Test Required
Yes
Health Screen Required
Yes
Motor Vehicle Record Inquiry Required
No
Posting Statement

The University of Chicago is an Affirmative Action/Equal Opportunity/Disabled/Veterans and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender, gender identity, national or ethnic origin, 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.

Staff Job seekers in need of a reasonable accommodation to complete the application process should call 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.

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