Ann & Robert H. Lurie Children's Hospital of Chicago · 1 day ago
Clinical Research Operations Manager
Streeterville, Chicago, IL
Full-time
Onsite
Mid Level
$83K/yr - $137K/yr
3+ years expAnn & Robert H. Lurie Children's Hospital of Chicago provides superior pediatric care and is ranked in all 10 specialties by the U.S. News & World Report. The Clinical Research Operations Manager will coordinate clinical research activities, implement recruitment strategies, and ensure compliance with regulations while working closely with various departments.
ChildrenHealth CareHospitalMedical
Responsibilities
Conducts study start-up activities and prepares and maintains all regulatory documents required by sponsor and/or regulatory agencies
Prepares protocols, informed consent documents, modifications, renewals and other necessary documents for review by the IRB and/or sponsor
Coordinates study conduct with other departments to effectively implement clinical research projects; obtains required letters of support and/or approvals as needed (i.e. IBC, SRC, etc.) and protocol is followed
Identifies and recruits eligible study subjects; conducts informed consent/assent process
Arranges and conducts clinical research visits
Conducts site qualifications, study initiation, monitoring and/or close-out visits
Attends investigator meetings
Abstracts data from medical records and enters medical information/data onto protocol specific case report forms, study flow sheets, and other required study forms; prepares abstracted/coded data for processing/analysis
Creates and/or updates case report forms and/or source document templates and/or data dashboards
Coordinates reimbursement of subjects
Maintains inventory of supplies/equipment
Prepares lab kits and requisitions prior to visits
Collects specimens from subjects and processes specimens or works with Research lab to ensure samples are processed/sent out correctly
Records data on source documents and CRF’s and/or electronic web based systems
Conducts literature searches and assists with QA/QC procedures
Adheres to research protocol in compliance with applicable institutional, local and federal regulations (OHRP, FDA, GCP, etc.)
Maintains all study documents (regulatory binders, source documents, correspondence, etc.)
Promotes the ethical conduct of research by actively participating in research related educational meetings/conferences (planning, presenting, etc.)
Performs job functions adhering to service principles with customer service focus of innovation, service excellence and teamwork to provide the highest quality care and service to our patients
QA/QC checks for database validity and data monitoring
Tracking deadlines for grants/deliverables
Coordinates and guides the creation and implementation of a recruitment & retention plan associated with clinical research, Investigator Initiated, Sponsored, & Outcomes studies involving human subjects ensuring the protection of their safety, rights, and welfare
Determines, interprets and applies rules and regulations (LCH, local, state, federal, industry, sponsor, etc.) and recommends and guides principal investigators (PIs) and research staff in the creation, submission, documenting, reporting, etc. of study recruitment and enrollment activities ensuring appropriate compliance
Acts as liaison between research staff (PI, faculty, nurses, technicians, etc.), and internal/external regulatory and oversight groups (LCH’s IRB, sponsors (NIH, industry), government agencies (FDA), etc.), advertisers, etc. to resolve issues and problems, negotiate compromises, and offer alternatives and recommendations to facilitate and expedite study recruitment and enrollment while ensuring compliance
Creates research study recruitment materials and execute implementation of marketing materials across multiple platforms (e.g., print, digital, radio, television)
Designs recruitment screening tools and best practices to support clinical and outcomes research in collaboration with CRP’s, DAR, IM, and the IRB. Facilitate script development and feedback sessions with hospital Advisory Boards and community stakeholders
Develop and facilitate research protocols related to measuring the use and effectiveness of educational videos and other recruitment materials in the research community
Evaluate barriers to increase recruitment of children, teenagers, and young adults who are underrepresented in bio-medical research
Assist teams in creation of recruitment plans and materials prior to IRB submissions until study is completed
Qualification
Required
High School Diploma with three to five years of clinical research experience -or
Associates /two years of College with two to four years research experience –or-
Bachelors with one to three years research experience
Good clinical practices documentation required
Preferred
Knowledge of research regulations (FDA, OHRP, GCP, etc.) preferred
Familiarity and experience with FDA and IRB regulatory requirements preferred
Clinical Research Experience preferred
Benefits
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
Various voluntary benefits:
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
Company
Ann & Robert H. Lurie Children's Hospital of Chicago
Ann & Robert H. Lurie Children's Hospital of Chicago is the largest pediatric healthcare provider in the region with a 130 year legacy of excellence.
1001-5000 employees
H1B Sponsorship
Ann & Robert H. Lurie Children's Hospital of Chicago has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (23)
2024 (19)
2023 (30)
2022 (16)
2021 (17)
2020 (11)
Funding
Current Stage
Late StageTotal Funding
$13.95MKey Investors
Baby Safety FoundationNational Cancer InstituteAce Hardware
2025-10-07Grant
2024-11-04Grant· $3.7M
2019-09-27Grant· $0.25M
Leadership Team
Audrey Rosenblatt
Director Advanced Practice Anesthesia Services
Recent News
2025-10-07
2025-07-16
Company data provided by crunchbase