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Becca D.
Information Security Management & Compliance | CompTIA Security+ Certified | CCNA Cyber Ops Certified
Manchester Center, VT, United States
Details
Education:
Undergraduate Certificate
Computer and Information Systems Security/Information Assurance
American Public University System
2013 : 2014
Bachelor of Science (B.S.)
Biology
Middle Tennessee State University
1996 : 1999
Associate of Science (A.S.)
Natural Resource Management
Volunteer State Community College
1993 : 1995
CCNA Cyber Ops
Cisco Cybersecurity Scholarship Curriculum Global Knowledge FY17Q3 (Cohort 2)
2017 : 2017
Computer and Information Systems Security/Information Assurance
American Public University System
2013 : 2014
Bachelor of Science (B.S.)
Biology
Middle Tennessee State University
1996 : 1999
Associate of Science (A.S.)
Natural Resource Management
Volunteer State Community College
1993 : 1995
CCNA Cyber Ops
Cisco Cybersecurity Scholarship Curriculum Global Knowledge FY17Q3 (Cohort 2)
2017 : 2017
Experience:
- PCI DSS compliance and payment card security
- Information security awareness training & communication
- Policy development
- Incident response coordination
- Project planning and execution
2014 : Present
Company name withheld
Information Security Analyst, Supervisor
I managed two of the facility's four research review committees. I also coordinated the office's migration from an Access-based project tracking system to the IRBNet Web-based system. During my time at the Albany Stratton VA Medical Center, I introduced a pre-review process and moved the program away from paper-based submissions, yielding significant improvements in overall turnaround time; collaborated with other departments to improve working relationships and information sharing; and successfully managed all four of the research review committees for several months during a period of short staffing.
2012 : 2014
Department of Veterans Affairs
Program Specialist, Research (GS-11) (Functional Role : IACUC and Research Safety Committee Manager)
As product manager and subject matter expert for InfoEd's Clinical Trials and Human Subjects modules, I wrote detailed enhancement specifications and testing scripts, provided demonstrations, configured the software, and assisted as needed with post-review, testing, and documentation. I also consulted with clients to help them resolve operational issues. I wrote high-quality, SEO-optimized content for the company's blogs and microsites, which played a direct role in boosting InfoEd's Google search ranking. My other key contributions included a long-term redevelopment plan for one of the modules and a white paper describing the system’s ability to support compliance with 21 CFR Part 11.
2011 : 2012
InfoEd Global
Product Manager (Clinical Trials and IRB Management Software)
I started in a junior-level analyst position and worked my way up to become the manager of a 10-member IRB with weekly meetings and oversight of approximately 1000 active projects. I led teams of professional staff to consistently meet or exceed departmental standards for quality and turnaround time of new project applications, continuing reviews, amendments, unanticipated problem reports, and emergency use requests. I independently made determinations regarding exempt research, non-human subject, and non-research projects in accordance with applicable regulations and departmental policies/procedures. During my time at Vanderbilt, I developed a thorough understanding of the department's information systems and worked closely with the MIS team to design enhancements. I was frequently called upon to test and evaluate new sytems being considered by the department, and informally provided first-line technical support to other staff members. My accomplishments included leading process improvement initiatives, mentoring new team leaders, and successfully preparing several of my staff for promotion. I earned the Certified IRB Professional (CIP) credential during this time and co-founded a new chapter of the Society for Clinical Research Associates (SoCRA).
2003 : 2011
Vanderbilt Human Research Protection Program
Protocol Analyst IV, Team Leader (Functional Role : IRB Manager)
As a new college graduate, I started in an entry-level position providing support for clinical trials. I was promoted and trained as a Clinical Research Associate before transferring to Regulatory Affairs, where I focused on clearing investigative sites for study startup. I received a second promotion in that role and also earned the Certified Clinical Research Professional credential (CCRP-SoCRA). My greatest contribution to the company's success was to identify and propose a workflow change that simplified the screening process for a large, multicenter drug trial. My suggested change reduced administrative burden and costs, and more importantly, lessened the risk and inconvenience to study participants.
1999 : 2003
ICON Clinical Research
Regulatory Document Specialist
- Information security awareness training & communication
- Policy development
- Incident response coordination
- Project planning and execution
2014 : Present
Company name withheld
Information Security Analyst, Supervisor
I managed two of the facility's four research review committees. I also coordinated the office's migration from an Access-based project tracking system to the IRBNet Web-based system. During my time at the Albany Stratton VA Medical Center, I introduced a pre-review process and moved the program away from paper-based submissions, yielding significant improvements in overall turnaround time; collaborated with other departments to improve working relationships and information sharing; and successfully managed all four of the research review committees for several months during a period of short staffing.
2012 : 2014
Department of Veterans Affairs
Program Specialist, Research (GS-11) (Functional Role : IACUC and Research Safety Committee Manager)
As product manager and subject matter expert for InfoEd's Clinical Trials and Human Subjects modules, I wrote detailed enhancement specifications and testing scripts, provided demonstrations, configured the software, and assisted as needed with post-review, testing, and documentation. I also consulted with clients to help them resolve operational issues. I wrote high-quality, SEO-optimized content for the company's blogs and microsites, which played a direct role in boosting InfoEd's Google search ranking. My other key contributions included a long-term redevelopment plan for one of the modules and a white paper describing the system’s ability to support compliance with 21 CFR Part 11.
2011 : 2012
InfoEd Global
Product Manager (Clinical Trials and IRB Management Software)
I started in a junior-level analyst position and worked my way up to become the manager of a 10-member IRB with weekly meetings and oversight of approximately 1000 active projects. I led teams of professional staff to consistently meet or exceed departmental standards for quality and turnaround time of new project applications, continuing reviews, amendments, unanticipated problem reports, and emergency use requests. I independently made determinations regarding exempt research, non-human subject, and non-research projects in accordance with applicable regulations and departmental policies/procedures. During my time at Vanderbilt, I developed a thorough understanding of the department's information systems and worked closely with the MIS team to design enhancements. I was frequently called upon to test and evaluate new sytems being considered by the department, and informally provided first-line technical support to other staff members. My accomplishments included leading process improvement initiatives, mentoring new team leaders, and successfully preparing several of my staff for promotion. I earned the Certified IRB Professional (CIP) credential during this time and co-founded a new chapter of the Society for Clinical Research Associates (SoCRA).
2003 : 2011
Vanderbilt Human Research Protection Program
Protocol Analyst IV, Team Leader (Functional Role : IRB Manager)
As a new college graduate, I started in an entry-level position providing support for clinical trials. I was promoted and trained as a Clinical Research Associate before transferring to Regulatory Affairs, where I focused on clearing investigative sites for study startup. I received a second promotion in that role and also earned the Certified Clinical Research Professional credential (CCRP-SoCRA). My greatest contribution to the company's success was to identify and propose a workflow change that simplified the screening process for a large, multicenter drug trial. My suggested change reduced administrative burden and costs, and more importantly, lessened the risk and inconvenience to study participants.
1999 : 2003
ICON Clinical Research
Regulatory Document Specialist
Company:
Company name withheld
Years of Experience:
25
Skills
Auditing, Behavioral Interviewing, Business Analysis, EMV, Information Assurance, Information Management, Information Security, Information Security Awareness, Integration, Leadership, Management, PCI DSS, Policy, Privacy Regulations, Process Improvement, Program Evaluation, Program Management, Project Management, Quality Assurance, Regulations, Regulatory Affairs, Research, Software Documentation, Team Leadership, Technical Writing, Testing, Training
About
Information security analyst with 15 years prior experience in research administration, regulatory affairs, and compliance, including 8 years leading and coaching others.
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