Kevin Abner
Nashville,TN
Summary
Fantastic at problem-solving and verifying regulatory and institutional compliance information. Fantastic critical thinker with great memory and efficiently organize vast amounts of data.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Lead Regulatory Compliance Analyst
Vanderbilt University Medical Center
06.2019 - Current
- Integrated Science Team leader
- Train new department/team analysts to ensure resources are readily available for success
- Coordinate and supervise team agendas before, during, and after committee meetings
- Develop goals and aims for the team based upon strengths of the analyst
- Ensure continuity and consistency of the research proposal process under occasional guidance
- Facilitate the protocol process from submission to completion
- Review and track new research proposals, continuing review of existing research protocols, adverse event reporting and database management of all research protocols involving human subjects
- Collaborate on development and revision of existing policies and procedures as well as development of new policies and procedures
- Routinely initiate team quality audits to ensure analyst are equipped with necessary resources to be successful
- Provide support with compliance reviews and directed audits for the research community and provide analysis of results and note alternatives for resolution of issues
- Ensure Committee reviews are accurately deciphered and notify to the research community via written communication to clearly communicate study related concerns
- Lead Committee Meetings to ensure members have all information needed to complete reviews and to answer any regulatory and institutional policy questions that may arise
- Conduct initial and amendment reviews on Exempt, Non-Research, and Non-Human studies
- Provide assistance to the research community with any escalated or complex concerns which may arise.
- Maintained composure in stressful situations, confrontations, interviews and records searches.
- Conducted periodic compliance audits and reviews to identify areas of improvement.
- Developed and implemented corrective action plans for non-compliance issues.
- Collected detailed notes on investigations and other communication to adhere to legal requirements and enhance recordkeeping.
- Assisted with development of compliance objectives and strategies.
- Identified gaps in existing compliance processes and recommended updates.
Lead Pathology Support Services
Vanderbilt University Medical Center
02.2014 - 06.2019
- Serve as lead for the Surgical Pathology, Hematopathology, and Cytogenetic laboratories
- Oversee daily operations, provide training, and mentoring of staff
- Create and edit training manuals, policies, and standard operating procedures for department
- Train and cross train employees within the Surgical Pathology, Hematopathology, and Cytogenetic labs in daily workflow procedures
- Coordinated the filing and storage of Pathologic slides and paraffin blocks
- Manage operational processes to store, retrieve, track and process surgical specimens, archived materials, and related information independently
- Lead and take part in compliance, quality management and quality improvement activities
- Managed operational processes to store, retrieve, track and process Cytogenetic specimens, and related information independently
- Lead improvement projects across the Anatomic & Clinical Pathology laboratories
- Beta tester and super user for new system introductions, or when upgrading laboratory systems.
- Utilized ticketing system to track customer requests and prioritize urgent needs.
- Intervened in escalated situations to obtain support and reduce escalation or recurrence risks.
Education
Bachelors of Science - Business administration
Western Governor's University
Nashville, TN01.2019
Skills
- Compliance Monitoring
- Policy analysis
- Quality Control
- Performance Evaluation
- Records Review
- Data Analysis
- Regulatory knowledge
Skillsprojects
- HRPP liaison for a research study about informed consent updates
- Aided to create a certification training program.
- Single IRB Point Person
- Project team to revamp the department intra and internet site.
- Knowledgeable with Microsoft Excel
- Project Team for end user survey
Certification
- CompTIA Project+
- Certified IRB Professional (CIP)
Activities
- Downtime activities include reading (thriller/suspense novels).
- Season ticket holder for the Tennessee Performing Arts Broadway series.
- Writing person/entertainment blog.
Additional Information
Downtime activities include reading (thriller/suspense novels).
Season ticket holder for the Tennessee Performing Arts Broadway series.
Creative writing through personal/entertainment blog.
Timeline
Lead Regulatory Compliance Analyst
Vanderbilt University Medical Center
06.2019 - Current
Lead Pathology Support Services
Vanderbilt University Medical Center
02.2014 - 06.2019
Bachelors of Science - Business administration
Western Governor's University
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