Regulatory Associate - Clinical Research Management Office - Georgetown University Medical Center

$47,586 - $87,558/Yr

Georgetown University - Washington, DC

Full-time - Entry Level

Washington, DC

Educational Services

About the position

The Regulatory Associate in the Clinical Research Management Office (CRMO) at Georgetown University Medical Center plays a crucial role in supporting cancer treatment clinical trials conducted by Lombardi Investigators. This position is responsible for managing all regulatory activities associated with clinical trials, ensuring compliance with institutional, state, and federal guidelines. The Regulatory Associate will prepare, maintain, and coordinate regulatory submissions and documentation for various types of clinical research studies, including investigator-initiated, industry-initiated, and National Cancer Institute NCTN studies. Key responsibilities include creating and coordinating regulatory submissions for oncology clinical research trials, which encompass initial review committee submissions, protocol amendments, consent form revisions, routine progress reports, and serious adverse event reporting. The Regulatory Associate will also be tasked with organizing study regulatory files, entering trial information into the Clinical Trials Management System (CTMS), and effectively communicating trial status to various stakeholders, including investigators and trial sponsors. In addition to these duties, the Regulatory Associate will assist in compiling regulatory-related metrics for senior management, attend Disease Group meetings to provide updates on trial activity, and participate in trial site initiation visits and audits. The role requires adherence to Good Clinical Practice (GCP) guidelines and compliance with Human Subject Protection regulations, ensuring that all activities are conducted in accordance with applicable laws and institutional policies. This position is hybrid, allowing for a combination of remote and on-site work, and is integral to the successful management of clinical trials at Georgetown University Medical Center.

Responsibilities

• Create, coordinate, and facilitate regulatory submissions of oncology clinical research trials.
• Create and revise informed consent documents, HIPAA forms, and other regulatory documentation.
• Organize study regulatory files including regulatory submissions and essential regulatory documents.
• Enter new trial information and regulatory submission data into the Clinical Trials Management System (CTMS).
• Participate in study activation management activities, ensuring forms and requests are completed accurately and timely.
• Effectively communicate trial status and updates to investigators and other stakeholders throughout the trial lifecycle.
• Assist with compiling regulatory-related metrics for senior management.
• Attend assigned Disease Group meetings and provide updates on trial activity.
• Prepare for and participate in trial site initiation visits, monitoring visits, close-out visits, and audits.
• Submit applications to the FDA for Investigational New Drug (IND) applications as required.
• Maintain research practices using Good Clinical Practice (GCP) guidelines.
• Perform all duties in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.

Requirements

• Bachelor's degree in a science related field.
• 3 to 5 years regulatory affairs or clinical research experience.
• Strong working knowledge of FDA, NCI, OHRP, and Good Clinical Practice.
• Excellent verbal and written communication skills.
• Excellent organizational skills and attention to detail.
• Reliability and ability to prioritize competing responsibilities.

Nice-to-haves

• SOCRA, ACRP, RAPS, and/or CIP certification.

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Disability insurance
• Life insurance
• Retirement savings
• Tuition assistance
• Work-life balance benefits
• Employee discounts
• Voluntary insurance options