Position Type : Full Time
Provide overall administrative support to the Regulatory Office and the Clinical Research Unit (CRU) in the Abramson Cancer Center (ACC). Overall administrative support includes but is not limited to:
* Prepare, organize, and maintain necessary paperwork and regulatory documents for the regulatory team including CVs/Medical Licenses, Laboratory Certifications, 1572s, Financial Disclosure Forms, and Delegation of Authority Logs for up to approximately 300 trials.
* Review and maintain regulatory files for compliance and quality assurance. Resolve regulatory-related queries and interact with study sponsors/monitors regarding regulatory requests, work with study monitors/auditors to satisfy regulatory requirements; follow up with regulatory coordinators as needed related to pending submissions.
* Update/maintain study records in the Clinical Trials Management System (Velos).
* Receive, process, and prepare necessary regulatory documentation for all off-site IND safety reports on-going under the CRU.
* Prepare, process and file necessary documentation related to protocol specific study team training at the time of initial protocol activation, on-going study updates, and interim re-training opportunities.
* Organize, schedule and attend study visits as needed, including study selection visits and site initiation visits
* Oversee general administrative needs of the Administrative Director, Supervisors and General CRU including ordering supplies, maintaining contact lists, maintaining attendance records for meetings, scheduling maintenance needs for equipment as needed, scheduling, reserving conference rooms
Position is contingent on continued funding.