Clinical Research Coordinator I (PRN)-Genetics

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

5d•Onsite

About The Position

The clinical research coordinator position in the Division of Genetics will be supporting clinical trials that focus on rare genetic disorders. These conditions include the mucopolysaccharidoses (MPS) disorders, phenylketonuria (PKU), Fabry disease, neurofibromatosis, and other inborn errors of metabolism. Treatment regimens could include enzyme replacement therapy, gene therapy and other exciting new treatment options. The CRC will work collaboratively with Lurie Children’s Hospital teammates, CRO’s and external sponsors to ensure that timelines are met.

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.
High School Diploma/GED: Biomedical Science (Required)

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

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