Regulatory Associate II, Lombardi Comprehensive Cancer Center - Georgetown University

Employer
Georgetown University
Location
Washington, OH
Posted
Jul 19, 2021
Closes
Jul 22, 2021
Ref
2329511397
Organization Type
Corporate
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 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). The incumbent will 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 of the Regulatory Associate 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.
  • Provide guidance and training to entry level Regulatory Associates and other CRMO staff.
  • Identify opportunities for improvement or enhancement in clinical research processes, based on personal experience and information acquired from other programs, peers, and review of literature.
  • Maintain research practices using Good Clinical Practice (GCP) guidelines.
  • Other duties as assigned.

Perform all duties in accordance with applicable laws and regulations. Adhere to Georgetown University Medical Center's philosophies, policies, and SOPs. Work in compliance with Human Subject Protection, patient confidentiality/HIPAA, and GCP.

Work Interactions

This position reports to and works closely with the CRMO Regulatory Manager and requires excellent communication skills and the ability to interact effectively with a wide variety of individuals.
  • 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

Qualifications
  • Bachelor'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 candidates exhibit:
  • Strong working knowledge of FDA, NCI, OHRP, and Good Clinical Practice.
  • Excellent verbal and written communication skills.
  • Excellent organizational skills and attention to detail.
  • Reliable and able to prioritize competing responsibilities.

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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.