Clinical Research Coordinator III - Advanced Therapeutics Initiative (ATI)

Ann & Robert H. Lurie Children's Hospital of Chicago•Chicago, IL

17h•Onsite

About The Position

Coordinates all clinical research activities with minimal supervision and adheres to service values, research ethics, and study protocols. The balance of patient-facing and data-administrative responsibilities varies according to program needs. The role oversees clinical research projects from study start-up through close-out, including site visits, regulatory compliance, participant engagement, data management, project logistics, and support for financial and grant activities. The coordinator also trains and mentors research personnel and contributes to dissemination of research findings.

Requirements

Bachelor’s degree.
At least two 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 technological systems.
Strong leadership skills, including prioritization, problem-solving, and mentoring ability.
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.
Experience assisting with technology system implementation.

Responsibilities

Coordinate and oversee clinical research projects, including start-up, site qualifications, initiation, monitoring, and close-out visits.
Oversee site visits, respond 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 to the FDA, and develop and update SOPs.
Promote ethical research conduct and integrity in study activities and data handling.
Manage project logistics and administration, including inventory, lab kits and requisitions, study documents, regulatory binders, source documents, grant and deliverable deadlines, and data-dictionary codebooks.
Identify and recruit eligible participants; conduct informed consent and assent processes; coordinate reimbursements; verify eligibility; and respond to study-related inquiries and support needs.
Abstract medical-record information, enter data into case report and study forms, prepare coded data for analysis, conduct statistical analyses, and maintain database validity and integrity through QA/QC and monitoring.
Assist with budget preparation and fund review, and support the research central offices and Principal Investigator with grant preparation and reporting.
Train, mentor, and serve as a resource for research personnel; assist with onboarding new study team members.
Contribute to dissemination of research findings through manuscript preparation, abstracts, 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 a Health Savings Account.
Flexible Spending Accounts.
Paid Time Off (PTO), paid holidays, and paid parental leave.
403(b) with a 5% employer match.
Voluntary benefits, including 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 specialized behavioral health services and resources for employees and family members.
Discounts on services at Lurie Children’s facilities.
Discount purchasing program.
Wellbeing programs.