Located in a historic neighborhood in the nation's capital, Georgetown offers rigorous academic programs, a global perspective, exciting ways to take advantage of Washington, D.C., and a commitment to social justice. Our community is a tight knit group of remarkable individuals interested in intellectual inquiry and making a difference in the world.RequirementsRegulatory Associate - Clinical Research Management Office - Georgetown University Medical Center Georgetown’s Clinical Research Management Office (CRMO) (https://lombardi.georgetown.edu/research/resource-members/crmo/#ga=2.78649940.1552305900.1665023716-524040626.1661785538) provides administrative, nursing, and data management support for cancer treatment clinical trials conducted by Lombardi Investigators. This includes all regulatory documents, IRB submissions, budget and contract negotiations, consenting of subjects, case management of patients while on study, side effect management, completion of case report forms, meeting with monitors, maintaining trial information on the Lombardi website (https://lombardi.georgetown.edu/tag/clinical-trials/) , and design of electronic case report forms for institutional trials.Job OverviewThe Regulatory Associate is responsible for conducting regulatory activities for clinical trials in the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC). They prepare, maintain, and coordinate regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for investigator-initiated, 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, including but 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
Adhere to Georgetown University Medical Center’s philosophies, policies, and SOPs
Perform duties in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP
Work InteractionsReporting to and working closely with the CRMO Regulatory Manager, the Regulatory Associate interacts effectively with a wide variety of individuals, including but not limited to:
Regulatory Manager
Disease Group members: Principal Investigators, Physicians, Clinicians
Clinical Research Management Office (CRMO) members: Clinical Research Nurses, Clinical Research Coordinators, Data Managers, Regulatory Coordinators, Laboratory Technicians
External department faculty and staff: Institutional Review Board (IRB), Clinical Research Committee (CRC), Radiation Safety Committee, Office of Research Quality Assurance (ORQA), Clinical Research Operations Office (CROO), Research Pharmacy
Clinical trial sponsors, auditors, and study monitors
This 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.Qualifications
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
Ability to prioritize competing responsibilities
Preferred qualificationsSOCRA, ACRP, RAPS, and/or CIP certificationWork 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 (https://hr.georgetown.edu/mode-of-work-designation/) .Pay Range: The 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 Employees: If 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 Guidelines: Please 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 Assistance: If you are a qualified individual with a disability and need a reasonable accommodation for any part of the application and hiring process, please click here (http://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 Statement: Georgetown University is an Equal Opportunity/Affirmative Action Employer (https://policymanual.hr.georgetown.edu/https%3A//policymanual.gudrupal.georgetown.edu/201-Equal-Employment-Opportunity-Affirmative-Action) 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 (http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf) .Benefits: Georgetown 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 (https://benefits.georgetown.edu/staff/enrolling/) . We’re a leading research university with a heart. Founded in the decade that the U.S. Constitution was signed, we’re the nation’s oldest Catholic and Jesuit university. Today we’re a forward-looking, diverse community devoted to social justice, restless inquiry and respect for each person’s individual needs and talents. Grounded in our Jesuit, Catholic identity, the Spirit of Georgetown undergirds everything we do. Watch this video (https://www.youtube.com/watch?v=hq3KF11PSNc) to learn more. Learn how HR CARES (https://hr.georgetown.edu/hr-cares/) for faculty and staff, nurturing an environment of mutual respect where imaginations flourish and ideas are realized to positively impact the world. Georgetown 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 (https://benefits.georgetown.edu/staff/enrolling/) .