Clinical Research Coordinator I

Description

Based on specific research program needs, patient facing vs. data administrative responsibilities will vary. Under direct supervision.

Area Specific Job Accountabilities :

• Assists with study start-up and the preparation and maintenance of all regulatory documents required by sponsor and / or regulatory agencies.
• Assists with the preparation of protocols, informed consents, modifications, renewals and other necessary documents for review by the IRB and / or sponsor.
• Assists clinical research personnel in the implementation of clinical research projects.
• Assists in the identification and recruitment of eligible study subjects.
• Helps arrange study visits and provide instructions to study participants / families.
• Facilitates study initiation, monitoring and close-out visits.
• May attend investigator meetings.
• Abstracts data from medical records and enters medical information / data onto protocol specific case report forms (CRF), study flow sheets, and other required study forms.
• Assists in creating and updating case report forms and / or source document templates.
• Coordinates reimbursement of subjects.
• Maintains inventory of supplies / equipment.
• Prepares lab kits and requisitions prior to visits.
• Collects specimens from subjects and processes specimens as instructed.
• Records data on source documents and CRF’s and / or electronic web based systems.
• Conducts literature searches and assists with QA / AC procedures.
• Assists with adverse event monitoring and reporting.
• Adheres to research protocol in compliance with applicable institutional, local and feral regulations (OHRP, FDA, GCP, etc.).
• Helps triage patient questions.
• Helps maintain all study documents (regulatory binders, source documents, correspondence, etc.).
• Seizes opportunities to enhance knowledge of research conduct / regulations by attending relevant educational meetings / conferences.
• 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.

Data Management Responsibilities :

• Enter data and code in a data dashboard.
• Assists in creating and updating data spreadsheets.
• Timely data retrieval from medical records.
• Prepare data for analysis.
• Importing and exporting data in various formats.
• Consenting for expedited / minimal risk studies.
• Identifies patient eligibility per study criteria.

Knowledge, Skills and Abilities :

• High School Diploma with two years research experience -or-
• Associates / two years of College with one year research experience or-
• Bachelors with no research experience.
• Knowledge of research regulations (FDA, OHRP, GCP, etc.) preferred.
• Strong organizational and communication skills required.
• Familiarity with Excel database basics.

Education High School Diploma / GED (Required) Benefit Statement For full time and part time employees who work 20 or more hours per week we offer a generous benefits package that includes : Medical, dental and vision insuranceEmployer paid group term life and disabilityEmployer contribution toward Health Savings AccountFlexible Spending AccountsPaid Time Off (PTO), Paid Holidays and Paid Parental Leave403(b) with a 5% employer matchVarious 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

There’s a Place for You with Us At Lurie Children’s we embrace and celebrate diversity and equity in a serious way. We are committed to building a team with a variety of backgrounds, skills, and viewpoints recognizing that diverse identities strengthen our workplace and the care we can provide to the Chicago community and beyond.

We treat everyone fairly, appreciate differences, and make meaningful connections that foster belonging and allyship. This is a place where you can be your best, so we can give our best to the patients and families who trust us with their care. Support email :