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

Employer
Georgetown University
Location
Washington D.C.

View more

Administrative Jobs
Academic Affairs, Research Staff & Technicians
Employment Type
Full Time
Institution Type
Four-Year Institution


Regulatory Associate for Clinical Management Research Office, Lombardi Comprehensive Cancer Center Georgetown University Medical 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.

Requirements

Regulatory Associate for Clinical Management Research Office, Lombardi Comprehensive Cancer Center - Georgetown University Medical Center

Georgetown Lombardi Comprehensive Cancer Center (LCCC) - part of Georgetown University Medical Center - seeks to prevent, treat and cure cancers by linking scientific discovery, expert and compassionate patient care, quality education and partnership with the community — guided by the principle of cura personalis, “care for the whole person.” Georgetown Lombardi is the research engine driving clinical cancer research at MedStar Health in the D.C. Metro area and northern New Jersey.

The Regulatory Associate participates in all regulatory related activities for the LCCC 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, sponsor-initiated, and NCI NCTN clinical research studies. Reporting to the Regulatory Manager, and collaborating with LCCC staff, representatives from cooperative groups, clinical research organizations, other institutions, and pharmaceutical companies, the Regulatory Associate has duties that include but are not limited to:

Clinical Trial Regulatory Management
  • Create, coordinate, and facilitate regulatory submissions of oncology clinical research trials - for example, 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
  • Attend protocol-related training and complete all required study training in the specified 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


Departmental & Other Responsibilities
  • Attend and participate in Regulatory team meetings, staff meetings, and other departmental meetings and training
  • Attend study team meetings and provide updates on protocol activities
  • Attend protocol-related training and complete all required study training in the specified timeframe
  • Attend assigned Disease Group meetings and provide updates on protocol activities
  • Assist with compiling regulatory-related metrics for use by senior management
  • Maintain research practices using Good Clinical Practice (GCP) guidelines
  • Assist in the development and implementation of policies and standard operating procedures (SOPs).


Qualifications
  • Bachelor's degree in related field and at least 1 to 3 years of experience in regulatory affairs or clinical research [or High School diploma and at least 5 to 7 years of experience in regulatory affairs or clinical research]
  • Strong working knowledge of FDA, NCI, OHRP and/or ICH GCPs
  • Excellent communication skills (oral and written), as well as the ability to interact effectively with a wide variety of individuals
  • Outstanding organizational skills
  • Exceptional attention to detail
  • Knowledge of institutional, state and federal regulatory guidelines
  • Ability to learn quickly and work independently and efficiently with minimum supervision
  • Ability to independently prioritize tasks and to work under pressure


Preferred qualification

SoCRA, ACRP, RAPS, or CIP certification

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 [email protected].

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://apptrkr.com/2502913





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