Sr. Regulatory Specialist, Clinical Research Management Office - Georgetown Lombardi Comprehensive Cancer Center
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.
The Sr. Regulatory Specialist is responsible for participating in all regulatory related activities for the Clinical Research Management Office (CRMO) of the Lombardi Comprehensive Cancer Center (LCCC). The Sr. Regulatory Specialist will prepare, maintain, and coordinate regulatory submissions and documentation in compliance with institutional, state, and federal guidelines for investigator initiated, sponsor-initiated, and NCI NCTN clinical research studies. Assist regulatory manager with mentoring junior staff. Primary responsibilities include, but are not limited to:
Regulatory Management - These primary duties will be performed for all subcategories
Responsible for coordinating and facilitating CRC and IRB submissions including, but not limited to: initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance
Responsible for entering study information and ensuring accuracy of information in Oncore
Communicates with investigators and research staff throughout the various stages of the study life cycles
Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments
Responsible for the creation and revisions to informed consent and HIPAA forms
NCTN and NCORP Trials
Communicates with NCI CIRB as applicable
Responsible for maintaining RCR updates and registration including electronic 1572s
Manage CTEP accounts and responsible for rostering
Investigator Initiated Trials
Responsible for maintaining essential regulatory documents
Assists investigator with clinicaltrials.gov registration and updates
Submit and maintains annual approval for Investigational New Drug (IND) applications to the Food and Drug Administration as required.
Industry Sponsored Trials
Responsible for maintaining essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation
Prepares for and participates in sponsor monitoring visits and audits.
Assists in the development and implementation of policies and standard operating procedures (SOPS)
Attends applicable LCCC meetings including, but not limited to disease group meetings, SIVs, IMVs, and COVs.
This position requires excellent communication skills and the ability to interact effectively with a wide variety of individuals including investigators, clinical research coordinators, administrative staff, and representatives from cooperative groups, clinical research organizations, other institutions, and pharmaceutical companies. The Sr. Regulatory Specialist reports to and works closely with the regulatory manager to streamline processes and assist in the implementation of standardized functions.
A minimum of 3-5 years experience in regulatory affairs or clinical research with Bachelor's degree in a related field or a minimum of 1-3 years experience in regulatory affairs or clinical research with a Master's degree.
SoCRA, ACRP, RAPS, or CIP certification preferred.
Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs.
Outstanding organizational skills, oral and written communication skills.
Exceptional attention to detail. Knowledge of institutional, state and federal regulatory guidelines.
Ability to learn quickly and work independently and efficiently with minimal supervision.
Ability to independently prioritize tasks, and to work under pressure.
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.
Please 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.
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 for more information, or contact the Office of Institutional Diversity, Equity, and Affirmative Action (IDEAA) at 202-687-4798 or email@example.com.
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.
Georgetown 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.
Georgetown University offers a wide variety of comprehensive and competitive benefits. Benefits packages include comprehensive health, dental and vision plans, disability and life insurance coverage, retirement savings programs, tuition assistance, voluntary insurance options (including group legal, accident, and critical illness), and much more. Whatever your need, the Office of Faculty and Staff Benefits will be standing by to support you. You can learn more about the benefits offered to eligible faculty and staff at https://benefits.georgetown.edu or view the online interactive benefits guide for more information.
Established in 1789, Georgetown is the nation's oldest Catholic and Jesuit University. Georgetown is one of the world's leading academic and research institutions, offering a unique educational experience that prepares the next generation of global citizens to lead and make a difference in the world.