FDA Program Administrator/Clinical Research Monitor

• →Perform risk-based monitoring
• →Develop monitoring plans for new sponsor-investigator clinical trials and studies that get approved through the radioactive drug research committee (RDRC)
• →Author monitoring confirmation letters and follow-up reports
• →Assist study teams in authoring CAPAs as needed
• →Maintain a dashboard to provide metrics on monitoring visits and to identify areas of risk and opportunities for training
• →Serve as a back-up for the following:
  • →Draft and submit the following submissions to the FDA on behalf of the sponsor-investigators: IND/IDE exemption, IND/IDE initial submission, amendments, annual reports, safety events, closures and single patient/emergency use
  • →Manage high volume of submissions at any given time with multiple urgent deadlines
  • →Assist sponsor-investigator in responding to FDA’s requests for information
  • →Draft and submit the following submissions to the IRB: single patient/emergency use (initial submission, reportable new information, continuing reviews, closure)
  • →Maintain dashboard that provides metrics on submission time, requests for submissions and on upcoming annual reports
• →Train investigators/study teams on how to use Veeva SiteVault, eTMF and EDC and serve as a resource for questions on using the system
• →Provide best practices on how to perform aspects of clinical research
• →Assist in FDA inspections as needed
• →Other tasks as needed

Demonstrated ability to work in and foster an environment of respect, professionalism and civility with a population of faculty, staff, and students from all backgrounds and experiences, or a commitment to do so as a staff member at VCU.

• 3+ years of relevant work experience involving clinical research, monitoring and the FDA
• Have monitored clinical trials
• Experience with radiation oncology or radiopharmaceutical studies
• Experience submitting various types of FDA submissions to the FDA for research including initial submissions, annual reports and safety reports of IND, IDEs and expanded access applications
• Experience utilizing electronic systems that are utilized in clinical research such as a CTMS, electronic investigator site file and EMR
• Experience working with different indications including addiction, oncology and non-oncology
• Relevant professional certification(s) in aspects of clinical research

• 1-2 years of relevant work experience involving clinical research, monitoring and the FDA
• Bachelor’s degree
• Familiarity with the various types of FDA submissions including IND, IDEs and expanded access
• Ability to handle high volume of studies with increasing complex study designs
• Ability to handle high volume of FDA submissions with consistently changing deadlines
• Experience working as a clinical research coordinator or in a role involved in clinical research
• Ability to communicate clearly and effectively both verbally and in writing
• Knowledge of FDA and ICH-GCP regulations
• Ability to maintain integrity, objectivity, independence and confidentiality
• Ability to manage workload to work efficiently and meet deadlines as needed
• Ability to interact with individuals of various positions and with an array of personalities
• Experience utilizing electronic systems that are utilized in clinical research such as a CTMS, electronic investigator site file and EMR
• Experience working with different indications
• Have monitored clinical trials