Clinical Research Coordinator II-Heart Center
About The Position
The Clinical Research Coordinator II-Heart Center coordinates clinical research activities with moderate supervision, adhering to research ethics and service values. The balance of patient-facing and administrative data tasks varies by research program. The role manages study initiation, regulatory compliance, study documentation, research visits, data and specimens, participant engagement, supplies, deadlines, and study finances. It also supports research quality and data organization, contributes to investigator meetings and educational initiatives, and represents research findings at meetings and conferences.
Requirements
- Bachelor’s degree and one year of research experience; a directly related combination of education and/or experience may be considered in lieu of the degree.
- Organizational skills to manage multiple studies.
- Verbal and written communication skills.
- Knowledge of FDA, HSR, and GCP guidelines.
- Analytical skills, including recognizing quantitative and qualitative research methods, and adaptability to various technological systems.
- Entry-level leadership skills.
- Ability to prioritize tasks, solve problems, and work with others.
Responsibilities
- Coordinate clinical research study initiation and regulatory compliance, preparing documents for IRB and sponsor review, coordinating study conduct across departments, and securing approvals.
- Manage regulatory binders, source documents, and correspondence to ensure adherence to study protocols.
- Coordinate and oversee clinical research visits, including arranging and conducting visits and conducting site qualification, initiation, monitoring, and close-out visits.
- Collect and process subject specimens, record data in source documents and electronic systems, conduct literature searches, and assist with QA/QC procedures.
- Manage participant engagement by identifying eligible subjects, conducting informed consent, coordinating reimbursement, verifying eligibility, and serving as the primary patient liaison for study inquiries and support.
- Manage supplies and equipment inventory, including preparing lab kits and requisitions.
- Track deadlines for grants and deliverables.
- Prepare abstracted and coded data for processing and analysis and develop codebooks for data dictionaries.
- Participate in investigator meetings, support ethical research conduct through educational initiatives, and represent research findings at meetings and conferences.
- Assist with study financial tasks, including invoicing and billing management.
- Perform other job functions as assigned.
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
- 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 for employees and family members
- Discount on services at Lurie Children’s facilities
- Discount purchasing program
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
