Regulatory Associate I

Georgetown University comprises two unique campuses in the nation’s capital. With the Hilltop Campus located in the heart of the historic Georgetown neighborhood, and the Capitol Campus, just minutes from the U.S. Capitol and U.S. Supreme Court, Georgetown University offers rigorous academic programs, a global perspective, and unparalleled opportunities to engage with Washington, D.C. Our community is a close-knit group of remarkable individuals driven by intellectual inquiry, a commitment to social justice, and a shared dedication to making a difference in the world.RequirementsJob OverviewDutiesThe 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. 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.Maintain research practices using Good Clinical Practice (GCP) guidelines.Other duties as assigned.All Lombardi CTO Regulatory Associates 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.Work InteractionsThis position reports to and works closely with the Lombardi CTO Regulatory Team Manager and requires excellent communication skills and the ability to interact effectively with a wide variety of individuals.Regulatory Team ManagerDisease Group members: Principal Investigators, Physicians, CliniciansLombardi CTO Team Members: Clinical Research Nurses, Clinical Research Coordinators, Data Coordinators, Regulatory Coordinators, Laboratory TechniciansExternal department faculty and staff: Institutional Review Board (IRB), Scientific Review Committee (SRC), Radiation Safety Committee, Office of Research Quality Assurance (ORQA), Clinical Research Operations Office (CROO), Research PharmacyClinical trial sponsors, auditors, and study monitorsRequirements And QualificationsBachelor’s Degree in a science related field required.Three to five (3-5) years regulatory affairs or clinical research experience required.SoCRA, ACRP, RAPS, or CIP certification preferred.Strong working knowledge of FDA, NCI, OHRP, and Good Clinical PracticeExcellent verbal and written communication skills, organizational skills, and attention to detailReliability and ability to prioritize competing responsibilitiesWork Mode DesignationThis position has been designated as 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 website: https://hr.georgetown.edu/mode-of-work-designation.Pay RangeThe projected salary or hourly pay range for this position which represents the full range of anticipated compensation is:$47,586.00 - $87,558.13Compensation is determined by a number of factors including, but not limited to, the candidate’s individual qualifications, experience, education, skills, and certifications, as well as the University’s business needs and external factors.Current Georgetown EmployeesIf you currently work at Georgetown University, please exit this website and login to GMS (gms.georgetown.edu) using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.Submission GuidelinesPlease note that in order to be considered an applicant for any position at Georgetown University you must submit a resume for each position of interest for which you believe you are qualified. Documents are not kept on file for future positions.Need AssistanceIf you are a qualified individual with a disability and need a reasonable accommodations for any part of the application and hiring process, please visit the Office for Equal Opportunity Compliance website for general information about requesting accommodations, as well as information about requesting accommodations specifically for applicants. You also can also contact the Office for Equal Opportunity Compliance at (202) 687-4798 or oeoc@georgetown.edu.Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website.EEO StatementGU is an Equal Opportunity Employer. All qualified applicants are encouraged to apply, and will receive consideration for employment without regard to age, citizenship, color, disability, family responsibilities, gender identity and expression, genetic information, marital status, matriculation, national origin, race, religion, personal appearance, political affiliation, sex, sexual orientation, veteran status, or any other characteristic protected by law.BenefitsGeorgetown University offers a comprehensive and competitive benefit package that includes medical, dental, vision, disability and life insurance, retirement savings, tuition assistance, work-life balance benefits, employee discounts and an array of voluntary insurance options. You can learn more about benefits and eligibility on the Department of Human Resources website.Current Georgetown Employees If you currently work at Georgetown University, please exit this website and login to GMS https://gms.georgetown.edu/ using your Net ID and password. Then select the Career worklet on your GMS Home dashboard to view Jobs at Georgetown.Submission GuidelinesPlease note that in order to be considered an applicant for any position at Georgetown University you must submit a cover letter and resume for each position of interest for which you believe you are qualified. These documents are not kept on file for future positions.Need AssistanceIf you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click https://ideaa.georgetown.edu/ada for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or ideaa@georgetown.edu.Need some assistance with the application process? Please call 202-687-2500. For more information about the suite of benefits, professional development and community involvement opportunities that make up Georgetown's commitment to its employees, please visit the Georgetown Works website https://georgetownworks.georgetown.edu/EEO StatementGeorgetown University is an Equal Opportunity/Affirmative Action Employer fully dedicated to achieving a diverse faculty and staff. All qualified applicants are encouraged to apply and will receive consideration for employment without regard to race, color, religion, national origin, age, sex (including pregnancy, gender identity and expression, and sexual orientation), disability status, protected veteran status, or any other characteristic protected by law https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf