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Pediatric Clinical Research Coordinator 2

University of Chicago

University of Chicago

Chicago, IL, USA
Posted on Friday, December 22, 2023

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 (https://pediatrics.uchicago.edu/). 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.


Job Summary

The Pediatric Clinical Research Coordinator 2 provides support to the Section of Pediatric Gastroenterology. The CRC 2 will be involved in coordinating all aspects of studies under the supervision of a PI. The Clinical Research Coordinator 2 works under the direction of Dr. Amelia Kellar and the leadership within the Pediatric Clinical Trials Office. Clinical trial tasks may include study concept development, protocol development and writing, study administration and data collection for an investigator-initiated trial and other new research projects developed by the PIs.

In part, this role will assist with ensuring that the Intestinal Ultrasound (IUS) machine used for procedures is set up correctly by clinic staff and functional prior to clinic, ensuring that clinic staff are aware of which clinic patients require IUS and are assigned to the correct rooms, and identifying appropriate patients for consent into the Genesys project, the IUS protocol, and notifying clinic staff of consent. Additionally, the role will assist with procedure support, consenting patients for research studies (Genesys, IUS protocol), inputting IUS results into report template for Dr. Kellar to finalize, printing report for family if requested, inputting IUS procedure data into redcap, and ensuring a procedure note is sent to referring physician. The role will also assist Dr. Kellar with research projects (both IUS-related as well as clinical trials) in partnership with other members of the team.

Responsibilities

  • Manages all aspects of conducting clinical trials including screening, enrollment, subject follow-up, completion of the case report form, and adverse event reports.
  • Recruits and interviews potential study patients with guidance from PI and other clinical research staff.
  • Collects, processes, ships and stores specimens to appropriate laboratory according to established aseptic techniques.
  • Identifies and explains the responsibilities of principal investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
  • Coordinates 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.
  • 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.
  • Protects patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
  • Ensures standard operating procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
  • Maintains accurate and complete records which may include, but are not limited to, signed informed consent, relevant IRB approvals, source documentation, case report forms (CRF's), drug dispensing logs, and study related communication.
  • Understands 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.
  • May prepare and maintain protocol submissions and revisions.
  • May assist in the training of new or backup coordinators.
  • Coordinates and may participate in quality assurance reviews conducted by study sponsors, federal agencies, or specially designated review groups.
  • Analyzes 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 a college or university degree in related field.

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Work Experience:

Minimum requirements include knowledge and skills developed through < 2 years of work experience in a related job discipline.

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Certifications:

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Preferred Qualifications

Education:

  • Bachelor’s degree in health science field or MSc/PhD.

Experience:

  • 2-5 years clinical research experience, clinical trial experience, or relevant experience.
  • Experience coordinating multiple studies (e.g., investigator-initiated, industry-sponsored, multi-site trials).
  • Prior work experience in clinical/basic science/translational research.

Technical Skills or Knowledge:

  • Understanding of federal research regulations and identify the federal research organizations’ role in regulating human research participation.
  • Knowledge of data analysis.
  • Competent in general Microsoft Office Suite products.
  • Experience in SPSS, STATA, R, or equivalent.
  • Education and knowledge in biostatistics and statistical software (ie. SAS, MedCalc, Covidence).
  • Work with Redcap.

Preferred Competencies

  • Communicate in writing.
  • Communicate orally.
  • Comprehend technical documents.
  • Develop and manage interpersonal relationships.
  • Exercise absolute discretion regarding confidential matters.
  • Follow written and/or verbal instructions.
  • Give directions.
  • Handle sensitive matters with tact and discretion.
  • Handle stressful situations.
  • Learn and develop skills.
  • Maintain a high level of alertness.
  • Pay attention to detail.
  • Perform multiple tasks simultaneously.
  • Prioritize work and meet deadlines.
  • React effectively, quickly, calmly, and rationally during conflicts and emergencies.
  • Train or teach others.
  • Work effectively and collegially with little supervision or as member of a team.
  • Work independently.

Application Documents

  • Resume/CV (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

Exempt


Pay Frequency

Monthly


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 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.

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