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Ann & Robert H. Lurie Children's Hospital of Chicago · 1 day ago

Clinical Research Coordinator II

Streeterville, IL

Full-time

Onsite

Entry Level

$50K/yr - $82K/yr

1+ years exp

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care and is seeking a Clinical Research Coordinator II. This role involves coordinating clinical research activities, ensuring compliance with regulations, and managing participant engagement throughout clinical trials.

ChildrenHealth CareHospitalMedical

Responsibilities

Coordinates and manages the initiation and regulatory compliance of clinical research studies, including preparing all necessary documents for IRB and sponsor review, coordinating study conduct across departments, and securing required approvals

Manages study documents, including regulatory binders, source documents, and correspondence, while maintaining adherence and compliance to research protocols

Coordinates and oversees all aspects of clinical research visits, including arranging and conducting visits, conducting site qualifications, initiation, monitoring, and close-out visits

Collects specimens from subjects and ensures proper processing, records data on source documents and electronic systems, and conducts literature searches while assisting with QA/QC procedures to ensure data accuracy and protocol compliance

Manages participant engagement throughout clinical trials by identifying eligible subjects, conducting informed consent processes, coordinating reimbursement, verifying eligibility, and serving as the primary patient liaison for study-related inquiries and support

Manages and oversees all aspects related to supplies and equipment inventory, including preparation of lab kits and requisitions

Tracks and manages deadlines for grants and deliverables

Prepares abstracted and coded data for subsequent processing and analysis, while also developing codebooks for data dictionaries to ensure comprehensive data organization and accessibility

Participates actively in investigator meetings, contributing to the ethical conduct of research through educational initiatives, and represents research findings at meetings and conferences

Assists with financial aspects of studies including invoicing and billing management

Other job functions as assigned

Qualification

FDA GuidelinesGCP GuidelinesHSR GuidelinesClinical Research ExperienceAnalytical SkillsOrganizational SkillsVerbal CommunicationWritten CommunicationLeadership SkillsProblem Solving

Required

Bachelor's degree and one year research experience required

A combination of education and/or experience may be considered in lieu of the degree when the experience is directly related to the duties of the job

Proficient organizational skills with ability to manage multiple studies

Proficient verbal and written communications skills

Proficient knowledge of FDA, HSR, and GCP Guidelines

Proficient analytical skills with the ability to recognize quantitative and qualitative research methods and remain agile and adaptable to various technological systems

Proficient entry level leadership skills

Recognizes the need to prioritize tasks, problem solve, and work with others. Assists to foster an inclusive environment where all team members feel valued and respected