Position Overview:
In this role you will ensure IRB approved protocols are implemented and followed; execute the
informed consent process and monitor patient status and safety; collect and organize research
data; schedule and conduct study-specific training and site in-services to study related staff on
new or amended protocols, and educate patients and their families about treatments and
possible side effects. The Clinical Research Coordinator must also be able to perform clinical
tasks.
Responsibilities:
● Site preparation.
● Obtaining informed consent, patient screening and recruitment.
● Patient enrollment, and conducting study visits.
● Maintaining and dispensing study product and supplies.
● Completing and ensuring the quality of case report forms.
● Maintaining source documents
● Ensuring site quality.
● Maintain a thorough and meticulous working knowledge of protocol schemas and
● requirements.
● Collaborate with physicians to maintain strict protocol adherence and serve as a
● resource for members of staff.
● Writes patient information sheet for clinical studies for submission to IRB, as well as
● complete the necessary documents for IRB admission in a timely fashion.
● Participate in the development and implementation of patient educational materials.
● Writes patient information sheet (ICF) for clinical studies for admission to IRB, as well as
● complete the necessary documents for IRB submission in a timely fashion.
● Review research and administrative documents to determine action items, prioritizing
● and tracking action items.
● Responsible for completion, submission and tracking of regulatory documents to the
● IRB.
● Maintain and update research fund accounting files, research billing, budgets and
● transfer of funds.
● Respond to correspondence, data and informational requests.
● Analysis of statistical, resource, performance and budget data and generation of reports.
