Clinical Research Coordinator I

Ann & Robert H. Lurie Children's Hospital of Chicago•Chicago, IL

10d

About The Position

Ann & Robert H. Lurie Children’s Hospital of Chicago provides superior pediatric care in a setting that offers the latest benefits and innovations in medical technology, research and family-friendly design. As the largest pediatric provider in the region with a 140-year legacy of excellence, kids and their families are at the center of all we do. Ann & Robert H. Lurie Children’s Hospital of Chicago is ranked in all 10 specialties by the U.S. News & World Report. Location Ann & Robert H. Lurie Children's Hospital of Chicago Job Description Assists investigators and study team in the implementation, coordination, and conduct of clinical research activities. Adheres to the service values and principles as well as the principles of research ethics. Under direct supervision, the balance between patient-facing and administrative data tasks varies according to the specific requirements of each research program. Essential Job Functions: Assists with study start-up and the preparation and maintenance of all regulatory documents required by sponsors and regulatory agencies (i.e. regulatory binders, source documents, correspondence, etc). Assists with the preparation of protocols, informed consents, modifications, renewals and other necessary study documents for IRB and/or sponsor review. Assists clinical research personnel in the implementation of clinical research projects, assists in the identification and recruitment of eligible study subjects. Maintains inventory of study supplies and equipment. Prepares lab kits and requisitions prior to visits. Collects specimens from subjects and processes specimens as instructed. Helps arrange study visits and provide instructions to study participants and families. Coordinates reimbursement for study subjects. Helps triage patient questions. Assists with adverse event monitoring and reporting. Assists in creating and maintaining case report forms or source document templates. Abstracts data from medical records and enters information into study-specific forms and electronic data capture platforms. Facilitates study initiation, monitoring and close-out visits. May attend investigator meetings. Supports research activities by conducting literature searches, assisting with QA/AC procedures, entering, coding, creating, updating data spreadsheets, retrieving, preparing, and managing data through importing and exporting in various formats. Other job functions as assigned.

Requirements

Bachelor’s degree 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.
Good organizational skills.
Good verbal and written communications skills.
Some knowledge of FDA, HSR, and GCP Guidelines.
Proficient analytical skills with the ability to remain agile and adaptable to various technological systems.

Responsibilities

Assists with study start-up and the preparation and maintenance of all regulatory documents required by sponsors and regulatory agencies (i.e. regulatory binders, source documents, correspondence, etc).
Assists with the preparation of protocols, informed consents, modifications, renewals and other necessary study documents for IRB and/or sponsor review.
Assists clinical research personnel in the implementation of clinical research projects, assists in the identification and recruitment of eligible study subjects.
Maintains inventory of study supplies and equipment.
Prepares lab kits and requisitions prior to visits.
Collects specimens from subjects and processes specimens as instructed.
Helps arrange study visits and provide instructions to study participants and families.
Coordinates reimbursement for study subjects.
Helps triage patient questions.
Assists with adverse event monitoring and reporting.
Assists in creating and maintaining case report forms or source document templates.
Abstracts data from medical records and enters information into study-specific forms and electronic data capture platforms.
Facilitates study initiation, monitoring and close-out visits.
May attend investigator meetings.
Supports research activities by conducting literature searches, assisting with QA/AC procedures, entering, coding, creating, updating data spreadsheets, retrieving, preparing, and managing data through importing and exporting in various formats.
Other job functions as assigned.

Benefits

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 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