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Regulatory Specialist for Investigator Initiated Trials – Georgetown University Medical Center
Georgetown’s Lombardi Comprehensive Cancer Center (LCCC) seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community - guided by the principle of cura personalis - care for the whole person. Our Consortium Investigator Initiated Trials (IIT) Office support all operational aspects of single- and multi-site IITs regardless of Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements.
The Regulatory Specialist manages and supports all regulatory functions for Investigator Initiated Trials (IITs) originated within Lombardi Comprehensive Cancer Center (LCCC), and those for which the institution or the Principal Investigator serves as the Study Sponsor.
They are responsible for the management of FDA submissions and facilitation of regulatory communication between the PI and the participating sites. They also supports the IIT Coordinator with study start-up activities for participating sites, and with, maintenance, and coordination of regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for IITs. Duties include but are not limited to:
- 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.
- Provide guidance and training to entry level Regulatory Associates and other CRMO staff.
- Identify opportunities for improvement or enhancement in clinical research processes, based on personal experience and information acquired from other programs, peers, and review of literature.
- Maintain research practices using Good Clinical Practice (GCP) guidelines.
- Perform all duties in accordance with applicable laws and regulations. Adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs. Work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP
Reporting to the LCCC Consortium IIT Project Manager, the Regulatory Specialist interacts effectively with a wide variety of individuals, including:
- Consortium IIT Office Program Manager, Local IIT Office Project Manager, IIT Quality Control Coordinator(s), other IIT Office staff
- Disease Group members: Principal Investigators, Physicians, Clinicians
- Clinical and Protocol Data Management Office Team Members including the DC Clinical Research Management Office [CRMO] and NJ Clinical Trials Office [CTO]: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory Technicians
- Institutional offices supporting IITs on DC and NJ campuses, including Institutional Review Board (IRB), Clinical Research Committee (CRC), Radiation Safety Committee, Office of Research Quality Assurance (ORQA), Clinical Research Operations Office (CROO), Research Pharmacy
- Faculty, staff, and peers from Academic Medical Centers
- Clinical trial sponsors, auditors, and study monitors
- Bachelor’s Degree in a science related field – preference for Master’s degree
- Three to five (3-5) years regulatory affairs or clinical research experience required – preference for oncology clinical research experience
- In depth knowledge of, and skill in applying, applicable clinical research regulatory requirements, i.e. , Good Clinical Practice (GCP) and International Conference on Harmonisation (ICH) guidelines
- Good command of English language
- excellent communication and interpersonal skills and the ability to interact effectively with a wide variety of individuals
- Strong organizational and problem-solving skills
- Demonstrated ability to deliver results to the appropriate quality and timeline metrics
- Good team leadership skills
- Effective mentoring and training skills
- Excellent customer service skills
- Good judgement
- Effective presentation skills
- Ability to manage competing priorities
- Strong software and computer skills, including MS Office applications
- Ability to establish and maintain effective working relationships with coworkers, manager, and clients
- SOCRA or ACRP certification
- Experience with FDA submissions
Work Mode: Hybrid. Please note that work mode designations are regularly reviewed in order to meet the evolving needs of the University. Such review may necessitate a change to a position’s mode of work designation. Complete details about Georgetown University’s mode of work designations for staff positions can be found on the Department of Human Resources Mode of Work Designation .
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The Georgetown University community is committed to our public health approach and the important role that vaccines play in contributing to the safety of our University and our broader communities. Georgetown University requires students, faculty, staff and visitors to be fully vaccinated against COVID-19 and to have received a COVID-19 vaccine booster shot when eligible, or to have an approved medical or religious exemption. This requirement applies to all faculty and staff, including teleworking employees. Complete details and updates can be found in the Coronavirus (COVID-19) Resource Center .
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