LINDSEY OVERMAN
Bryant,AR
Summary
Over 12 years of experience in Research and I have obtained a Master's Degree in Clinical Research Administration. Proven ability to manage multiple studies/projects simultaneously, from study start up to study closure. Thorough understanding of IRB regulations. Adept to maintaining compliance with hospital and federal standards. Ability to liaison with physicians and nurses, as well as with representatives from pharmaceutical companies, CROs and academic institutions.
Overview
17
17
years of professional experience
1
1
Certification
Work History
Research Project Manager
SARC
04.2021 - Current
- Conduct job functions with utmost diligence, integrity and adherence to SOPs, FDA regulations and Good Clinical Practice
- Establish and maintain trial master file for essential documents
- Lead the development, review and finalization of protocol and study-related documents
- Conduct remote monitoring and prepare routine and custom data reports
- Lead cross unit collaboration to ensure effective and efficient delivery of all operational aspects of one or more studies
- Act as primary contact for assigned affiliates to maintain oversight of performance, issues and resolution
- Identifies and communicates resource requirements for each study
- Review safety information, prepare and submit safety reports
- Communicates regularly to the Director of Research Project Management on the status of assigned studies including the escalation of unresolved issues, updates on operational timelines and ensuring the maintenance, tracking and accuracy of operational data milestones
- Review and approve study related invoices
- Responds effectively and efficiently to protocol questions from sites, IRBs and external vendors
- Draft consent templates, review site consent forms prior to site IRB submission
- Assist sites with consent updates to ensure consent forms are complete and devoid of flaw
- Prepare the IND submission as needed for assigned projects
- Lead/host meetings, as needed
- Prepare and conduct Site Initiation Visits
Research Program Manager
University of Arkansas, Sciences
11.2016 - 04.2021
- UAMS Center for Birth Defects
- Coordinates and manages all aspects of the assigned research projects
- Develop and initiate work plans and timelines to fulfill study requirements
- Provide updates and status reports to the PI on a regular basis
- Participate in cooperative activities with funding agencies and other funded sites including participation in conference calls, meetings and study subcommittees to enhance developmental aspects of the study protocol and dissemination of data
- Serve as liaison and coordinate interaction between participating laboratories, data managers, data analysts and bioinformatics professionals involved in the projects
- Proactively identify barriers, explore solutions, propose and implement solutions while engaging the appropriate stakeholder(s)
- Establish and foster collaborative relationships with stakeholders interested in birth defects research locally and nationally to ensure ample and effective communication resulting in scientific products
- In collaboration with stakeholders, resolve research issues and questions of methodology, analysis and interpretation
- Coordinate study investigator/team meetings to build and foster multidisciplinary collaborative interactions to advance the science of birth defects research
- Includes scheduling, development of agenda, slide presentation, handouts, recording of minutes, etc
- Promote and facilitate research activities among investigators
- Conduct routine staff meetings to discuss progress and timeliness and to resolve issues
- In collaboration with data managers/programmers, maintain and enhance study databases
- Supervise study support staff and complete performance evaluations and disciplinary actions as needed
- Perform other tasks as necessary to meet project responsibilities
- Edits, writes, and coordinates IRB research protocol submissions (including development of research protocols, informed consent forms and source documents)
- Obtains and maintains IRB approvals, serves as liaison with IRB
- Responds to audit requirements and remediation, evaluates continuous training needs of study staff, and has a working knowledge of the UAMS IRB’s Investigator’s Handbook
- Develop and execute standard operating procedures to facilitate compliance with all institutional and governmental policies and regulations
- Oversee data collection protocols including logistical operations for dissemination of study materials and consent and transfer of biological specimens
- Develop quality assurance standards for identification of study participants, dissemination of study materials, and data collection activities
- Monitor and perform quality control steps on data entry and data management
- Audit participant files and call history notes and make decisions regarding participant dispositions
- Serve as point of contact for study participants to address rights of research subjects
- Document and report protocol deviations to the Section’s IRB representative and/or directly to the UAMS IRB to address and ensure regulatory compliance
- Conducts literature searches, reviews research findings
- Critically appraises biomedical literature to identify gaps in current knowledge and to describe and evaluate new methodologies and new research discoveries
- Maintains a reference database with relevant scientific literature pertaining to birth defects and relevant research and new scientific discoveries
- Assists PI with literature reviews, manuscripts (e.g., journal articles, abstracts, book chapters) grant submissions, and promotional and educational material (e.g., annual research reports, general information articles) by providing writing, editing, minor revisions, and formatting.
Clinical Research Coordinator III
University of Arkansas for Medical Sciences
09.2013 - 11.2016
- UAMS Cancer Clinical Trials Office
- Coordinates with Principal Investigator, department, and central administration to help ensure that clinical research and related activities are performed in accordance with Federal regulations and University and sponsoring agency policies and procedures
- Collaborates with PI and institution to respond to any audit findings and implement approved recommendations
- Collaborating with internal and external agencies to fulfill research requirements
- Coordinating the processing and shipment of subject specimens
- Maintaining study subject charts and verify source documents for clinical research purposes
- Submitting subject data to clinical trial sponsors and appropriate committees as needed
- Assists the PI in study feasibility assessments as requested
- Registering subjects to the appropriate coordinating center
- Coordinates participate tests and procedures
- Manage multiple clinical research protocols sponsored by cooperative groups and industry
- Develop case report forms
- Build budgets for cooperative and industry studies
- Submit grants
- Completes and maintains accurate case report forms (CRFs) for assigned research protocols
- Assures timely and accurate completion of electronic Case Report Forms for data entry
- Identifies study candidates internally using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion
- Attentive to data queries and resolve them within the require timeframe
- Anticipates and assists with preparation of site monitoring visits
- Assists the monitor during visits to resolve all queries promptly
- Attends teleconferences and Investigator Meetings as requested by research manager
- Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections
- Review the patient’s medical record to assess the patient’s eligibility to participate in the study
- Review medical records and obtain source documentation for case report forms
- Prepare for or participate in quality assurance audits conducted by study sponsors, federal agencies, or specially designated review groups
- Review proposed study protocols to evaluate factors such as sample collection processes, data management plans, and potential subject risks
- Oversee subject enrollment to ensure that informed consent is properly obtained and documented
- Identify protocol problems, inform investigators of problems, or assist in problem resolution efforts such as protocol revisions
- Submit IRB submissions for cooperative and industry sponsored studies
- Revise protocol and consent forms as needed
- Primary contact for study initiation for industry sponsored studies
- Assist investigators in evaluating compliance with protocol requirements, data management and Good Clinical Practice
- Primary contact for new potential industry sponsored studies
- Maintain regulatory binders for industry, cooperative and investigator initiated studies
- QA subject binders for peers in preparation for audits with internal compliance office and cooperative group audits
Sciences Monitoring Specialist
University of Arkansas for Medical
02.2008 - 09.2013
- UAMS Research Support Center
- Develop Case Report Forms
- Maintain website for department
- Perform clinical research project reviews by monitoring medical records, regulatory binders, CRFs, AEs and SAEs, and informed consents
- Conduct written reports for all clinical research project reviews
- Develop regulatory binders for Principal Investigators
- Conduct ARIA system activity for monitoring plan development
- Conduct SharePoint system activity for monitoring plan development
- Develop Monitoring standard operating procedures
- Monitor and verify clinical research data for adherence to state, federal, and/or international regulations and institutional policies
- Schedule and conduct monitoring visits to analyze and evaluate clinical data, regulatory documents, adverse events, and drug accountability for UAMS Sponsored IND/IDE studies to ensure compliance with protocol and overall clinical objectives
- Follow up with the investigative staff to assure that queries related to study data have been answered and that required reporting has been completed
- Train and help develop electronic regulatory binders
- Travel to monitor multi-site studies
- Develop and maintain department SharePoint site
- Assistant in the development and maintenance of the departmental website
- Monitor and verify clinical research data for adherence to state, federal, and/or international regulations and institutional policies
- Organize investigator start-up meeting and study site initiation meetings
- Be the point of contact when investigators enquire about patient inclusion/exclusion criteria for ongoing trials
- Ensures compliance with the patient-consent process
- Verifies the receipt, handling, accounting, storage conditions, and availability of clinical products under investigation
- Verifies compliance and quality of collected data
Sciences Records Administrator
University of Arkansas for Medical
10.2006 - 02.2008
- UAMS Research Support Center
- Maintain a database of all files for reference
- Record archivist
- Provide administrative support to the Quality Assurance Unit
- Coordinate appointments and calendars activities
- Maintain unit activities and goals
- Responsible for procurement and travel utilizing SAP
- Responsible for inventory of all Research Compliance records
- Assist Education Manager in setting up training and seminars
- Assist GTP Specialist with donor medical record review, recipient follow up, site visits, compliance issues, and record management
- Develop QAU and Monitoring standard operating procedures
- Set up and maintain archives for Quality Assurance Unit according to federal regulations regarding GMP, GTP, and GLP
- Assist Education Manager in setting up training and seminars
- Responsible for procurement and travel utilizing SAP
- Responsible for inventory of all Research Compliance records
Education
Master of Science - Clinical Research Administration
Walden University
Baltimore, MDBachelor of Business Administration - undefined
University of Arkansas
Little Rock Little Rock, Arkansas2009
Skills
- Research Management
- Regulatory Compliance Oversight
- Microsoft programs
- Budget Development
- GCPs
- Treatment Protocols
- Personnel Management
- Problem Resolution
Certification
Certified Clinical Research Associate – June 2010 – Current Certified Research Specialist – October 2007 – Current Medical Terminology Certification – February 2007
Society of Clinical Research Associates (SOCRA)
Publications
1. Farr, S. L., Klewer, S. E., Nembhard, W. N., Alter, C., Downing, K. F., Andrews, J. G., Collins, R. T., Glidewell, J., Benavides, A., Goudie, A., Riehle-Colarusso, T., Overman, L., Riser, A. P., Oster, M. E. (2020). Rationale and design of CH STRONG: Congenital Heart Survey To Recognize Outcomes, Needs, and well-beinG. American Heart Journal, 221, 106–113. doi: 10.1016/j.ahj.2019.12.021.
2. Overman L. & Klimberg S. (Eds.). (2019). Transactions of the Southern Surgical Association Volume CXXI, New York: Elsevier Inc.
3. Overman L. & Klimberg S. (Eds.). (2018). Transactions of the Southern Surgical Association Volume CXXIX, New York: Elsevier Inc.
4. Overman L. & Klimberg S. (Eds.). (2017). Transactions of the Southern Surgical Association Volume CXXVIII, New York: Elsevier Inc.
Presentations
1. 2020 NBDPN Annual Meeting. A Different look at NTD Prevention. Washington, D.C. Will present March 9, 2020.
Timeline
Research Project Manager
SARC
04.2021 - Current
Research Program Manager
University of Arkansas, Sciences
11.2016 - 04.2021
Clinical Research Coordinator III
University of Arkansas for Medical Sciences
09.2013 - 11.2016
Sciences Monitoring Specialist
University of Arkansas for Medical
02.2008 - 09.2013
Sciences Records Administrator
University of Arkansas for Medical
10.2006 - 02.2008
Master of Science - Clinical Research Administration
Walden University
Bachelor of Business Administration - undefined
University of Arkansas
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