Research Administrative Coordinator

Responsible for IRB preparation, submission, annual reporting, adverse reporting/deviations as required and amendment submissions as needed to keep all regulatory documents current and approved.

Takes part in the prescreening of study volunteers. Evaluates potential volunteers by obtaining in depth medical history as related to study inclusion/exclusion criteria.

Explain study requirements to volunteers, obtaining informed consents prior to study initiation.

Collaborates with faculty and clinical staff to coordinate scheduling of events per the protocol.

Collaborates with the P.I. to review data on an ongoing process to ensure adherence to the protocol activities and report any changes as needed to the sponsor or other regulatory agencies as needed/required.

Responsible for data collection and security of documentation as well as reporting to the granting agencies

Responsible for data entry and reconciliation of queries. Assurance that data is ALCOA-C compliant.

(Attributable, legible, contemporaneous, accurate and complete)

Responsible for prompt reporting of any serious adverse events to the PI, sponsor and any other regulatory agencies as required.

Maintains all regulatory documentation, accurate patient logs and study flow sheets. Conducts case file audits with study monitors on an ongoing basis.

Inventories and requisitions supplies.

Prepares biologic samples for shipping per central laboratory guidelines.

Performs other duties as assigned.