Clinical Research Coordinator III - Advanced Therapeutics Initiative (ATI)

Lurie Children's Hospital•Chicago, IL

1d•$59,280 - $96,928•Onsite

About The Position

Coordinates all clinical research activities with minimal supervision while adhering to service values, research ethics, study protocols, and regulatory requirements. The balance of patient-facing and data-administrative responsibilities varies according to the needs of the research program. The coordinator manages clinical research projects from start-up through close-out, supports participant engagement and data integrity, contributes to regulatory and financial processes, trains and mentors research personnel, and helps disseminate research findings.

Requirements

Bachelor’s degree.
Two or more years of research experience.
Strong organizational skills and ability to manage multiple simultaneous studies.
Strong verbal and written communication skills.
Strong knowledge of FDA, HSR, and GCP guidelines.
Strong analytical skills, including ability to recognize quantitative and qualitative research methods and adapt to different technology systems.
Strong leadership skills, including ability to prioritize tasks, solve problems, and mentor others.
Ability to foster an inclusive environment where team members feel valued and respected.

Nice To Haves

Two to three years of experience with complex research projects.
May assist in technology system implementation.

Responsibilities

Coordinate and oversee clinical research projects, including study start-up, site qualifications, initiation, monitoring, and close-out visits.
Oversee site visits, respond promptly to sponsor queries, and ensure adherence to study protocols and regulatory requirements.
Prepare and maintain regulatory documents; register studies on ClinicalTrials.gov when required; assist investigators with regulatory submissions such as FDA submissions; and develop and update SOPs.
Promote ethical research conduct and integrity in study conduct and data handling.
Manage project logistics and administration, including inventory of supplies and equipment, lab kits and requisitions, study documents, regulatory binders, source documents, deadlines for grants and deliverables, and codebooks for data dictionaries.
Engage study participants by identifying and recruiting eligible subjects, conducting informed consent and assent, coordinating reimbursement, verifying eligibility, and serving as a contact for study-related questions and support.
Manage research data by abstracting medical-record information, entering data into case report and study forms, preparing coded data for analysis, conducting statistical analyses, and maintaining database validity and integrity through QA/QC checks and monitoring.
Assist with budget preparation and fund review, and support research central offices and the PI with grant preparation and reporting.
Train and mentor research personnel, assist with study-conduct training, serve as a resource, and support onboarding of new team members.
Support dissemination of findings through manuscript preparation, collaboration on abstracts and posters, presentations at national meetings, and coordination of research education conferences.
Perform other job functions as assigned.

Benefits

Medical, dental, and vision insurance
Employer-paid group term life and disability insurance
Employer contribution toward Health Savings Account
Flexible Spending Accounts
Paid Time Off
Paid holidays
Paid parental leave
403(b) with a 5% employer match
Supplemental life, AD&D, and disability coverage
Critical illness, accident, and hospital indemnity coverage
Tuition assistance
Student loan servicing and support
Adoption benefits
Backup childcare and eldercare
Employee Assistance Program and specialized behavioral health services and resources
Discount on services at Lurie Children’s facilities
Discount purchasing program
Wellbeing programs