Quality Assurance Analyst - Georgetown University Medical Center

Organization: Georgetown University

Posted: 03 February, 2020

Washington,United states


Job description

Washington, DC|4.2| ||3 hours ago|Full-time| Education Bachelor's Degree Master's Degree Skills Clinical Research Communication Skills FDA Regulations Benefits Tuition Reimbursement Dental Insurance Health Insurance Vision Insurance Disability Insurance 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. Requirements The Quality Assurance Analyst is responsible for participating in all regulatory related activities for the Clinical Research Management Office (CRMO) of the 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 investigator initiated, sponsor-initiated, and NCI NCTN clinical research studies. S/he reports to and works closely with the regulatory manager to streamline processes and assist in the implementation of standardized functions. Additional responsibilities include, but are not limited to: Regulatory Management - Industry Sponsored Trials 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. Communicate with investigators and research staff (study team) throughout the various stages of the study life cycles. Inform research personnel about new regulatory policies,procedures, ICF changes, and protocol amendments. Responsible for the creation and revisions to informed consent and HIPAA forms. Responsible for maintaining essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation Prepare for and participates in sponsor monitoring visits and audits. Regulatory Management - NCTN Trials 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. Communicate with investigators and research staff throughout the various stages of the study life cycles. Inform research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments. Responsible for the creation and revisions to informed consent and HIPAA forms. Communicate with NCI CIRB as applicable. Regulatory Management - Investigator Initiated Trials 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. Communicate with investigators and research staff throughout the various stages of the study life cycles. Inform research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments. Responsible for the creation and revisions to informed consent and HIPAA forms. Responsible for maintaining essential regulatory documents. Assist investigator with clinicaltrials.gov registration and updates. Submit and maintain annual approval for lnvestigational New Drug (IND) applications to the Food and Drug Administration as required. CRMO Administration Assist in the development and implementation of policies and standard operating procedures (SOPS). Requirements and Qualifications Bachelor's degree in a related field or a minimum of 3-6 years experience in regulatory affairs or clinical research with a Master's degree A minimum of 5-7 years experience in regulatory affairs or clinical research with 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. 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. |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. Requirements The Quality Assurance Analyst is responsible for participating in all regulatory related activities for the Clinical Research Management Office (CRMO) of the 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 investigator initiated, sponsor-initiated, and NCI NCTN clinical research studies. S/he reports to and works closely with the regulatory manager to streamline processes and assist in the implementation of standardized functions. Additional responsibilities include, but are not limited to: Regulatory Management - Industry Sponsored Trials 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. Communicate with investigators and research staff (study team) throughout the various stages of the study life cycles. Inform research personnel about new regulatory policies,procedures, ICF changes, and protocol amendments. Responsible for the creation and revisions to informed consent and HIPAA forms. Responsible for maintaining essential regulatory documents including FDFs, 1572s, DOA logs, and other study-related documentation Prepare for and participates in sponsor monitoring visits and audits. Regulatory Management - NCTN Trials 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. Communicate with investigators and research staff throughout the various stages of the study life cycles. Inform research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments. Responsible for the creation and revisions to informed consent and HIPAA forms. Communicate with NCI CIRB as applicable. Regulatory Management - Investigator Initiated Trials 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. Communicate with investigators and research staff throughout the various stages of the study life cycles. Inform research personnel about new regulatory policies, procedures, ICF changes, and protocol amendments. Responsible for the creation and revisions to informed consent and HIPAA forms. Responsible for maintaining essential regulatory documents. Assist investigator with clinicaltrials.gov registration and updates. Submit and maintain annual approval for lnvestigational New Drug (IND) applications to the Food and Drug Administration as required. CRMO Administration Assist in the development and implementation of policies and standard operating procedures (SOPS). Requirements and Qualifications Bachelor's degree in a related field or a minimum of 3-6 years experience in regulatory affairs or clinical research with a Master's degree A minimum of 5-7 years experience in regulatory affairs or clinical research with 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. 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.