Regulatory Associate I

Georgetown University

12d•Hybrid

About The Position

The Regulatory Associate 1 position is responsible for conducting regulatory activities for clinical trials in the Lombardi Clinical Trials Office (CTO) of Lombardi Comprehensive Cancer Center (LCCC). The incumbent will prepare, maintain, and coordinate regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for multi-institutional, industry-initiated, and National Cancer Institute NCTN clinical research studies.

Requirements

Bachelor’s Degree in a science related field required.
Three to five (3-5) years regulatory affairs or clinical research experience required.
Strong working knowledge of FDA, NCI, OHRP, and Good Clinical Practice
Excellent verbal and written communication skills, organizational skills, and attention to detail
Reliability and ability to prioritize competing responsibilities

Nice To Haves

SoCRA, ACRP, RAPS, or CIP certification preferred.

Responsibilities

Create, coordinate, and facilitate regulatory submissions of oncology clinical research trials, which include, but are not limited to, initial review committee submission, protocol amendments, consent form revisions, routine progress reports and continuing review applications, serious adverse events, protocol deviations, and audit results.
Create and revise informed consent documents, HIPAA forms, and other regulatory documentation.
Submit applicable documents to study sponsors as required.
Organize study regulatory files including regulatory submissions, essential regulatory documents, and trial communication.
Enter new trial information, trial updates, regulatory submission data, and upload approved documents to the Clinical Trials Management System (CTMS) ensuring accuracy of data.
Participate in study activation management activities, ensuring forms and requests are completed accurately and in a timely manner.
Effectively and efficiently communicate trial status and updates to investigators, CRMO team members, outside departments and committees, trial sponsors, and other pertinent personnel throughout the trial lifecycle.
Assist with compiling regulatory-related metrics for use by senior management.
Attend assigned Disease Group meetings and provide updates on trial activity.
Attend protocol-related training and complete all required study training in the required timeframe.
Prepare for and participate in trial site initiation visits, monitoring visits, close-out visits, and audits.
Submit applications to the Food and Drug Administration for Investigational New Drug (IND) applications as required.
Maintain research practices using Good Clinical Practice (GCP) guidelines.
Perform all duties in accordance with applicable laws and regulations, while adhering to Georgetown University Medical Center’s philosophies, policies, and SOPs and work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.