Pediatric Clinical Research Coordinator 2 - Chicago, United States - The 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.

Job Summary

The Pediatric Clinical Research Coordinator 2 provides support to the Section of Pediatric Infectious Disease. 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. Madan Kumar and the leadership within the Pediatric Clinical Trials Office. While the Principal Investigator is primarily responsible for the overall design, conduct, and management of the clinical trial, the CRC2 supports, facilitates and coordinates independently the daily clinical research activities and plays a critical role in the conduct of the study. This role will work alongside physicians, research teams, and staff to fulfill projects focused on providing quality, patient-centered care through executing research operations, development of research processes and ensuring quality assurance metrics are met to achieve the goals of multiple research projects.

Responsibilities

• Manage 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.
• Collect, process, ship and store specimens to appropriate laboratory according to established aseptic techniques.
• Identify and explain the responsibilities of Principal Investigators, research team members, sponsors, contract research organizations (CROs), and regulatory authorities related to the conduct of a clinical trial.
• 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.
• Plan and coordinates patient schedule for study procedures, return visits, and study treatment schedules.
• Educate patients about study procedures to be performed, visit schedule, what to report between and during visits, and the risks and benefits of the procedures.
• Perform assessments at visits and monitors for adverse events.
• Organize and attend site visits from sponsors and other relevant study meetings.
• Protect patients and data confidentiality by ensuring security of research data and personal health information and compliance with federal regulations and sponsor protocols.
• Ensure Standard Operating Procedures (SOP) are implemented and documented in accordance to study sponsor, primary investigator, and regulatory agency specifications.
• Maintain 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.
• 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.
• Ensure 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.

—
Work Experience:

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

—
Certifications:

—

Preferred Qualifications

Education:

• Bachelor's Degree.

Experience:

• 2-5 Years Clinical Research experience or relevant experience.
• Experience coordinating multiple studies (e.g., investigator-initiated, industry-sponsored, multi-site trials).

Preferred Competencies

• 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.
• Knowledge of data analysis.
• Competent in general Microsoft Office Suite products.
• Ability to work with Redcap.
• 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.

​​​

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

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 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: . Paper copies of the Report are available, upon request, from the University of Chicago Police Department, 850 E. 61st Street, Chicago, IL 60637.

View or Apply

To help us track our recruitment effort, please indicate in your email – cover/motivation letter where ) you saw this job posting.