Advertising 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 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
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 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
Salary Range: 70,000 - 80,000
Benefits : All full-time university staff are eligible for
VCU’s robust
benefits
package that includes comprehensive health benefits, paid annual
and holiday leave, generous tuition benefits, retirement planning
and savings options, tax-deferred annuity and cash match programs,
employee discounts, well-being resources, abundant opportunities
for career development and advancement, and more.
Unit: Office of the Vice President for Research &
Innovation
Department: Strategy and Regulatory Affairs
FLSA Exemption Status: Exempt
Hours per Week: 40
Restricted Position: Yes
ORP Eligible: No
Flexible Work Arrangement: Hybrid
University Job Title: 25234N - Sr Specialist LG 1 -
Open
