Regulatory Associate, Clinical Research Management Office - Lombardi Comprehensive Cancer Center

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Requirements

Regulatory Associate, Clinical Research Management Office - Lombardi Comprehensive Cancer Center

Georgetown University's Lombardi Comprehensive Cancer Center (LCCC) seeks to improve the diagnosis, treatment, and prevention of cancer through innovative basic and clinical research, patient care, community education and outreach, and the training of cancer specialists for the future. Founded in 1970, LCCC is one of only 41 institutions in the nation designated by the NCI as a comprehensive cancer center, and it is the only comprehensive cancer center in the Washington, DC area.

The Regulatory Associate conducts regulatory activities for clinical trials in the LCC's Clinical Research Management Office (CRMO). 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's National Clinical Trial Network (NCTN) research studies. Reporting to the Regulatory Manager, the Regulatory Associate has responsibilities that include but are not limited to:

Regulatory Management - Industry Sponsored Trials, NCTN Trials, and Investigator Initiated Trials

• Coordinates and facilitates CRC and IRB submissions - such as initial submissions, amendments, ICF changes, progress reports, continuing reviews, and deviations while ensuring regulatory compliance.
• Enters study information and ensures accuracy of information in OnCore.
• Communicates with investigators and research staff (study team) throughout the various stages of the study life cycle.
• Informs research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments.
• Creates and revises informed consent and HIPAA forms.
• For Industry Sponsored Trials, also maintains essential regulatory documents, such as FDFs, 1572s, DOA logs, and other study-related documentation; and prepares for - and participates in - sponsor monitoring visits and audits.
• For NCTN Trials, also communicates with NCI CIRB as applicable.
• For Investigator-Initiated Trials, also maintains essential regulatory documents, assists investigator with www.clinicaltrials.gov registration and updates, and submits and maintains annual approval to the Food and Drug Administration for Investigational New Drug (IND) applications as required.

CRMO Administration

• 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, team meetings, SIVs, IMVs, and COVs.

Qualifications

• Bachelor's degree in a science-related field
• 3 to 5 years of experience in regulatory affairs or clinical research - preference for SoCRA, ACRP, RAPS, or CIP certification
• Strong working knowledge of FDA, NCI, OHRP, and ICH GCPs
• Outstanding organizational and verbal/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 work under pressure
• Excellent communication skills and the ability to interact effectively with a study team members in a wide variety of roles, as well as representatives of individuals from participating institutions

Current Georgetown Employees:

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Submission Guidelines:

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.

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 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.

EEO Statement:

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.

Benefits:

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.


To apply, visit https://georgetown.wd1.myworkdayjobs.com/en-US/Georgetown_Admin_Careers/job/Medical-Center/Regulatory-Associate--Clinical-Research-Management-Office---Lombardi-Comprehensive-Cancer-Center_JR10017





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