Clinical Research Coordinator III - Advanced Therapeutics Initiative (ATI)

10 HOSP Ann & Robert H. Lurie Children's Hospital of Chicago; Chicago (IL); On-site; USD 59,000 - 97,000; Full time

Benefits offered by this job

Medical, dental and vision insurance

403(b) with employer match

PTO and holidays

Job summary

Ann & Robert H. Lurie Children’s Hospital of Chicago is seeking a Clinical Research Coordinator to oversee all aspects of pediatric clinical studies. You will manage start-up, monitoring, and close-out visits, ensure regulatory compliance, and maintain study documentation.

The role includes coordinating participant engagement, data lifecycle tasks, and budget support. The position emphasizes ethical conduct, mentorship, and collaboration with investigators.

Qualifications

• Bachelor’s degree and two or more years research experience required.
• Two-three years with complex research projects preferred.
• Strong organizational skills with ability to manage multiple simultaneous studies.
• Strong verbal and written communications skills.
• Strong knowledge of FDA, HSR, and GCP Guidelines.
• Strong analytical skills with ability to recognize quantitative and qualitative research methods.
• May assist in technology system implementation.
• Strong leadership skills with ability to prioritize tasks, problem solve, and mentor.
• Ability to foster an inclusive environment where all team members feel valued and respected.

Responsibilities

• Coordinates and oversees all aspects of clinical research projects, including start-up, site qualifications, initiation, monitoring, and close-out visits.
• Oversees site visits, addresses sponsor queries, and ensures adherence to study protocols and regulatory requirements.
• Manages regulatory compliance and documentation, including regulatory submissions and SOPs.
• Promotes ethical conduct in research and ensures integrity in study conduct and data handling.
• Manages logistics and administrative aspects, inventory, lab kits, documents, and deadlines.
• Manages participant engagement: recruitment, consent/assent, reimbursement, eligibility, and inquiries.
• Manages the data lifecycle: abstracting, entering, coding, analysis, QA/QC and data monitoring.
• Supports in budget prep, fund review, and grant reporting activities.
• Provides training and mentorship to research personnel and assists onboarding.

Skills

Research coordination

Regulatory knowledge

GCP knowledge

Data management

Leadership

Communication skills

Mentoring

Education

Bachelor’s degree

Job description

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do.

Location

Simpson Querrey Biomedical Research Center

Job Description

Coordinates all clinical research activities with minimal supervision. Adheres to the service values and principles as well as the principles of research ethics. Based on specific research program needs, patient facing vs. data administrative responsibilities will vary.

Essential Job Functions

• Coordinates and oversees all aspects of clinical research projects, including study start-up, site qualifications, initiation, monitoring, and close-out visits.
• Oversees site visits, promptly addresses sponsor queries, and ensures strict adherence to study protocols and regulatory requirements throughout all study activities.
• Manages regulatory compliance and documentation processes, including preparing and maintaining regulatory documents, registering studies on clinicaltrials.gov if required, assisting investigators with regulatory submissions such as to the FDA, and developing and updating Standard Operating Procedures (SOPs) to ensure adherence to research protocols and regulatory standards.
• Promotes ethical conduct in research and ensures integrity in all aspects of study conduct and data handling.
• Manages logistical and administrative aspects of clinical research projects by maintaining inventory of supplies and equipment, preparing lab kits and requisitions, organizing, and maintaining study documents including regulatory binders and source documents, tracking deadlines for grants and deliverables, and constructing codebooks for data dictionaries.
• Manages participant engagement throughout clinical research studies by identifying and recruiting eligible subjects, conducting informed consent/assent processes, coordinating subject reimbursement, verifying participant eligibility, and serving as the primary point of contact for study-related inquiries and support.
• Manages the data lifecycle in clinical research by abstracting information from medical records, entering data into case report and study forms, preparing abstracted/coded data for analysis, conducting statistical analyses, and ensuring database validity and integrity through QA/QC checks and data monitoring processes.
• Manages some financial aspects of research projects by assisting in budget preparation and fund review, as well as supports the research central offices and Principal Investigator (PI) in grant preparation and reporting activities.
• Provides comprehensive training and mentorship to research personnel by assisting in study conduct training, serving as a mentor and resource, and assists the onboarding process for new study team members.
• Leads the dissemination of research findings through manuscript preparation, collaboration on abstracts/posters, presentation of research at national meetings, or coordination of research education conferences.
• Other job functions as assigned.

Knowledge, Skills, and Abilities

• Bachelor’s degree and two or more years research experience required.
• Two-three years with complex research projects preferred.
• Strong organizational skills with ability to manage multiple simultaneous studies.
• Strong verbal and written communications skills.
• Strong knowledge of FDA, HSR, and GCP Guidelines.
• Strong analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems.
• May assist in technology system implementation.
• Strong leadership skills with the ability to prioritize tasks, problem solve, and serve as a mentor.
• Ability to foster an inclusive environment where all team members feel valued and respected.

Education Pay Range

Pay Range $59,280.00-$96,928.00

Benefit Statement

• Medical, dental and vision insurance
• Employer paid group term life and disability
• Employer contribution toward Health Savings Account
• Flexible Spending Accounts
• Paid Time Off (PTO), Paid Holidays and Paid Parental Leave
• 403(b) with a 5% employer match
• Supplemental Life, AD&D and Disability
• Critical Illness, Accident and Hospital Indemnity coverage
• Tuition assistance Student loan servicing and support
• Adoption benefits
• Backup Childcare and Eldercare
• Employee Assistance Program, and other specialized behavioral health services and resources for employees and family members
• Discount on services at Lurie Children’s facilities
• Discount purchasing program

There's a Place for You with Us

Lurie Children’s and its affiliates (collectively “Lurie Children’s”), we embrace and celebrate diversity and equity in a serious way. We are committed to building a team with a variety of backgrounds, skills, and viewpoints — recognizing that diverse identities strengthen our workplace and the care we can provide to the Chicago community and beyond. We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging and allyship. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care.

Lurie Children’s and its affiliates are equal employment opportunity employers. We value diversity and are committed to creating an inclusive environment for all employees. All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity or expression, religion, national origin, ancestry, age, disability, marital status, pregnancy, protected veteran status, order of protection status, protected genetic information, or any other characteristic protected by law.

For questions about how to request an accommodation please contact: [e-mail]

AI Notice

Lurie Children’s utilizes certain AI-enabled features within our recruiting platform to support candidate engagement and assist recruiters in identifying and prioritizing applicants whose experience aligns with job requirements. All employment decisions are made by individuals. It is a civil rights violation with respect to recruitment, hiring, promotion, or employment for an employer to use artificial intelligence that has the effect of subjecting employees to discrimination on the basis of protected classes under the Illinois Human Rights Act or to use zip codes as a proxy for protected classes. For questions about the use of artificial intelligence in this process or any additional support, please contact: [e-mail]

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do.