FDA Program Administrator​/Clinical Research Monitor

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Summary:

Department Summary: At the VCU Office of the Vice President for Research and Innovation, our mission is to foster transformative research, discovery, and innovation at Virginia Commonwealth University through excellence in service.

We partner with faculty in all schools and departments as they seek funding, plan studies, establish collaborations, calculate budgets, submit grant applications, negotiate industry contracts, and secure patents and licensing agreements.

Our commitment to supporting and elevating the research community at VCU has resulted in record levels of sponsored research and has placed VCU among the nation’s premier public research universities.

Through our passion for discovery and willingness to take on challenges, we continue to advance the work that matters most and position the university as a national leader in research, innovation, creativity, and scholarship.

Duties & Responsibilities:

FDA program Administrator/Clinical Research Monitor

Responsibilities:

• 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 Site Vault, 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

Qualifications:

Minimum Qualifications:

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.

Only applicants who do not require current or future sponsorship for employment will be considered

• 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

Preferred Qualifications:

• 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…