Clinical Research Coordinator Lead - Fetal Institute

* Coordinates and oversees all aspects of clinical research projects, including study start-up, site qualifications, initiation, monitoring, and close-out visits.
* Manages multiple and complex clinical research protocols, tracks deadlines for grants and deliverables, and takes a leadership role in coordinating collaborative studies and managing multi-center research initiatives.
* Ensures project milestones align with strategic objectives and drives continuous improvement in research methodologies.
* Manages regulatory compliance and documentation processes, including preparing and maintaining regulatory documents, registering studies on clinical trials.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 participant engagement and compliance throughout clinical research studies, including identifying and recruiting eligible study subjects, conducting informed consent/assent processes, coordinating subject reimbursement, verifying participant eligibility, and serving as the primary patient liaison for study-related inquiries and support.
* Facilitates effective communication and collaboration among stakeholders to enhance participant recruitment and retention.
* Coordinates and executes all aspects of clinical research visits, including preparation of lab kits and requisitions, specimen collection, ensuring proper specimen processing by the research lab, and maintaining inventory of supplies and equipment essential for study protocols.
* Implements quality assurance measures to uphold data integrity and compliance with protocol requirements.
* Manages data lifecycle in clinical research, including abstraction from medical records, data entry into case report and study forms, statistical analysis, QA/QC for database integrity, and preparation of tables, figures, and formatting for grants, manuscripts, and reports to ensure accuracy and compliance.
* Develops and implements robust data management strategies to support research outcomes and regulatory requirements.
* Oversees financial management for clinical research studies, including budget preparation, invoicing, billing management, negotiation with sponsors, and ensuring accurate management of study fund accounts.
* Leads training and development initiatives for research personnel, assists in study team training and mentorship.
* Acts as a mentor and resource for other Research Professionals, coordinates research operation improvement activities, and provides guidance and leadership on complex protocols and projects. Supports onboarding of new study team members and maintains delegation of authority and training records.
* Leads the dissemination of research findings through publication preparation, collaboration on abstracts and posters for scientific meetings, presentation of research at national meetings, coordination of presentations at research education conferences, and overseeing the preparation and evaluation of abstracts, posters, and manuscripts.
* Other job functions as assigned.
* Bachelor’s degree and three or more years of research experience required.
* Three to four years with complex research projects preferred.
* Excellent organizational skills with ability to manage multiple simultaneous studies.
* Excellent verbal and written communications skills.
* Excellent knowledge of FDA, HSR, and GCP Guidelines.
* Excellent analytical skills with the ability to understand financial data, recognize quantitative and qualitative research methods.
* Remains agile and adaptable plus assists in implementation of various technological systems. Excellent leadership skills with the ability to prioritize tasks, problem solve, and mentor other team members.
* Ability to foster an inclusive environment where all team members feel valued and respected.

At Lurie Children’s, we are committed to competitive and fair compensation aligned with market rates and internal equity,…