Anise Sims
Valdosta,GA
Summary
Over 4 years of experience in clinical research. A passionate, driven, and forward-thinking Clinical Research Professional, with experience in global project delivery and global site outreach for clinical trials in all therapeutic areas. Perform clinical trial duties in adherence to the Protocol, Communication Plan, ICH, GCP, clinical trial processes, and any other requirements stipulated on the clinical trial. Excels at relationship building willing to work hard and get the job done. Eager and conscientious team player seeking to gain skills and experience. Adept at handling confidential and /or sensitive information. Motivated by the mission of advancing medicine and improving lives through innovative and collaborative projects. Brings diverse perspectives and experiences to the team, having worked in different therapeutic areas and settings.
Overview
14
14
years of professional experience
Work History
Site Identification Lead, Elite Sites
ICON Plc
05.2024 - Current
- Specifically sought out by Executive VP to come over and build a new department for Elite Sites.
- Create and implement comprehensive processes and procedures for managing elite sites ensuring clear and effective streamlined operations.
- Leads the identification and evaluation of potential clinical trial sites for pre-award and post awarded studies, focusing on elite research institutions/clinics.
- Develop and maintain a comprehensive database of elite sites with the capacity and expertise to conduct high quality clinical trials.
- Conduct thorough feasibility assessments to determine site capabilities, patient population, and potential challenges.
- Collaborate with cross functional teams to ensure alignment of site capabilities with study requirements and objectives.
- Establish and maintain strong relationships with elite site networks, and key stakeholders.
- Serve as the primary point of contact for elite sites, ensuring clear communication and addressing any concerns promptly.
- Analyze site performance metrics and provide detailed feedback to support decision making processes.
- Present findings and recommendations to senior management and project teams.
- Identify opportunities for process improvements in site identification and selection activities.
- Implement best practices and innovative approaches to enhance site identification, efficiency, and effectiveness.
- Maintain accurate and up-to-date documentation of site identification processes, decisions, and communications.
- Prepare and present regular reports on site identification, progress and outcomes to stakeholders.
- Work closely with Clinical Operations, Business Development, Director of Project Delivery, Feasibility, Project Management and other departments to ensure seamless integration of site identification activities into overall study planning and execution.
- Contribute to the development of the study proposal and site-specific plans based on site capabilities and expertise.
Site Identification Lead, Vaccines and EID
ICON plc
10.2023 - 05.2024
- Strategized in development meetings including requests for proposals, requests for information, and bid defense meetings giving feedback on sites such as enrollment projections, preparing Power Point slides, and effectively communicating with site networks and ICON study teams.
- Ensured and Adhered to ICON's Standard Operating Procedures (SOPs) and compliance with guidelines of ICH and GCP.
- Liaised with over 85 site networks in multiple therapeutic areas/indications providing clinical trial opportunities and updates on clinical trials.
- Lead weekly internal meeting and created agenda each week for Center for Vaccines and Emerging Infectious Disease and contributed to weekly internal Pediatric Clinical Development agenda as well.
- Managed the upkeep of Vaccines and Emerging Infectious Disease tracker.
- Managed the upkeep of site networks' information such as therapeutic areas, indications, site locations, metrics, and all other pertinent information.
- Communicated with Vice President, Directors of Project Delivery, Associate Directors, Project Managers, Study Start Up, and Senior Account Owners in all therapeutic areas for collaboration on clinical trials and site network outreach.
- Created, managed, and distributed monthly pipeline report to our site networks and departments within ICON.
- Managed the upkeep of clinical trials manually in all therapeutic areas for Pipeline Report and any other clinical trial outside of the pipeline report where my assistance is requested.
- Initiated and Managed MCDAs 21 CFR Part 11 for review and signature, ensuring contract is fully executed, and ensuring current MCDAs have not expired.
- Submitted project deliverables to ICON study teams and clients consistently adhering to quality standards.
Project Assistant, Vaccines and EID
ICON plc
06.2021 - 10.2023
- Strategized in development meetings including requests for proposals, requests for information, and bid defense meetings giving feedback on sites such as enrollment projections, preparing slides, and effectively communicating with site networks and study teams.
- Liaised with site networks on multitude of studies in multiple therapeutic areas and indications when study is currently being conducted, in process of being awarded, or site networks have shown interest.
- Lead and created weekly internal agenda for Center for Vaccines and Emerging Infectious Diseases and contribute to weekly internal Pediatric Clinical Development agenda as well.
- Managed Project Status Tracker and upkeep of Vaccines and Infectious Disease studies.
- Managed upkeep of site networks' information such as therapeutic areas, indications, site locations, metrics, and all other pertinent information.
- Communicated with Vice President, Directors of Project Delivery, Associate Directors, Project Managers, Study Start Up, and Senior Account Owners for various studies in all therapeutic areas for collaboration on site network outreach.
- Created, managed, and distributed monthly pipeline report to our site networks and departments within ICON.
- Managed upkeep of studies manually in all therapeutic areas for Pipeline Report and any other studies outside of pipeline report where my assistance is requested.
- Ensured and Adhered to ICON's Standard Operating Procedures (SOPs) and compliance with guidelines of ICH and GCP.
- Managed MCDAs for site networks ensuring contract is fully executed and has not expired.
- Produced thorough, accurate and timely reports from Salesforce of project activities.
- Submitted project deliverables to study teams, clients, consistently adhering to quality standards.
Project Associate
PRA HEALTH SCIENCES
01.2020 - 06.2021
- Organized internal project team meetings and sponsor meetings including scheduling meetings, preparing meeting materials, agendas meeting minutes and action items.
- Prepared, handled, distributed, filed, and archived study documentation and reports.
- Ensured client and investigator obligations were being met and followed applicable local regulatory requirements, ICH/GCP guidelines, and PRA SOPs.
- Performed study tracking via CTMS, TMF, and sponsor designated systems to ensure that study files are current, accurate, and complete.
- Accurately updated and maintained clinical systems within project timelines.
- Supported Project Manager, global team, and sponsor for designated project communications, correspondence, and associated documentation.
- Supported preparation of study files by maintaining and distributing project documents.
- Liaised with vendors in vendor management and other functional areas to meet project team goals.
- Managed clinical operations learning management system to assign project specific training to team members and track training compliance.
Human Resources Assistant
CITY OF OVERLAND PARK
09.2018 - 10.2019
- Managed Workers' Compensation Claims and updated those files.
- Assisted candidates with application processes by answering questions about the application, performing background checks, providing I-9 forms and handling drug screening paperwork.
- Guided new hires through orientation and onboarding and explained documentation requirements to facilitate HR process.
- Managed and processed Workers' Compensation bills that arrived from Hospitals and Doctor's Offices.
- Updated Bulletin Boards throughout the city to ensure compliance with State Workers' compensation laws and City Policy.
- Reconciled Workers' Compensation account to check register.
- Conducted monthly Motor Vehicle Reports and prepared a report of the findings.
- Performed random drug tests quarterly and as needed.
Human Resources Assistant
BEHAVIORAL HEALTH SERVICES OF SOUTH GEORGIA
01.2017 - 03.2018
- Reviewed incoming resumes and applications, full cycle recruiting, pre-screened and interviewed potential candidates.
- Recruited and pre-screened Therapists, RNs, LPNs, Intake Clerks, Human Service Techs, CNAs, Administrative Assistants, Site Managers, Receptionists, Janitors, and Security Guards.
- Managed new hire salary offers, managed I9 process, typed up offer letters and prepared all onboarding paperwork including background checks and drug tests.
- Maintained and utilized Applicant Tracking System.
- Maintained licensure and certification reports to be compliant with all federal, state, and regulatory standards.
- Created and posted job announcements on company website and other various job sites.
- Provided clerical and administrative support to HR Department.
- Assisted with Audits, employee investigations, terminations, and prepared proper paperwork for each one.
- Ensured all employees' paperwork was filed, scanned, and stored electronically.
- Audited files for compliance and followed up on required documentation.
- Enrolled all new and current employees in their online training classes using Relias.
- Trained new employees on company policies, online classes, answered other questions they may have and assisted with New Employee Orientation.
- Generated employee training reports each month and scheduled employee trainings.
Claims Specialist
LIFEPLANS
10.2015 - 10.2016
- Managed Data Entry in Excel for long-term care insurance and distributed appropriate documents when necessary.
- Informed Vice President and Director of Department on all open and closed long-term care insurance claim activity.
- Calculated Open and Closed Claims in Excel to make sure correct pay was issued.
- Analyzed data in Ins-Pro for accuracy and completeness against electronic copy in Excel.
- Conducted wide variety of record keeping activities, maintaining files and records.
Patient Care Coordinator
EXPRESS SCRIPTS
11.2013 - 02.2015
- Managed inquiries regarding PAP, pharmacy benefit, medicines, and managed documentation.
- Adhered to HIPAA guidelines while faxing or phoning for information.
- Communicated Medicaid, Medicare, and private insurance information to customer.
- Entered information into computer system, processed applications, orders, and refilled prescriptions.
- Knowledgeably communicated with patients, service providers, doctors, and clients.
- Effectively communicated with staff and manager daily.
Customer Service Representative
ELEAD CRM
05.2010 - 10.2013
- Contacted potential customers regarding purchase of new cars.
- Scheduled appointments for dealerships and conducted detailed customer follow up & surveys.
- Achieved promotion twice in 90 days for exemplary performance of duties and boosting car sales 5%.
- Prepared product or service reports by collecting and analyzing customer information..
Education
Bachelor of Science - Human Resource Management
PARK UNIVERSITY
Moody, GA05.2015
Skills
- Complex Problem Solving
- Team Collaboration/Leadership
- Work Planning and Prioritization
- Detail Oriented
- Project Management
- Spreadsheet Development
- Conflict Resolution
- Documentation and Reporting
- Creative Thinking
- Deadline Driven
- Relationship Building
- Technical Presentations
- Records Maintenance
- Adaptability
- Initiative-taking
- Interactive communication skills
Additional Information
HRIS, PeopleSoft, ATS, Relias, Quantum, I9, E-Verify, ID Pro, Origami, Crystal Report, Avatar, MVR, National Sex Offender, Secretary of State Licensing, Systems Award Management(SAM), G Suite (Gmail, Sheets, Docs, Slides, and Forms), Microsoft Office (Word, Excel, PowerPoint, Teams), Outlook, Medic, CMS, F14, LMS, Citrix, Benefits, Medical Records, Wiki Systems, Chatter, CTMS, Databasics, ETMF, Tableau, BI Publisher, PhlexEView, Portal, Predictivv Study Operations (PSO), Predictivv Team Assignments, Veeva Vault, and WebEx, Citeline, Trial Hub, BOX, DocuSign, SharePoint, SalesForce, and OneNote.
Timeline
Site Identification Lead, Elite Sites
ICON Plc
05.2024 - Current
Site Identification Lead, Vaccines and EID
ICON plc
10.2023 - 05.2024
Project Assistant, Vaccines and EID
ICON plc
06.2021 - 10.2023
Project Associate
PRA HEALTH SCIENCES
01.2020 - 06.2021
Human Resources Assistant
CITY OF OVERLAND PARK
09.2018 - 10.2019
Human Resources Assistant
BEHAVIORAL HEALTH SERVICES OF SOUTH GEORGIA
01.2017 - 03.2018
Claims Specialist
LIFEPLANS
10.2015 - 10.2016
Patient Care Coordinator
EXPRESS SCRIPTS
11.2013 - 02.2015
Customer Service Representative
ELEAD CRM
05.2010 - 10.2013
Bachelor of Science - Human Resource Management
PARK UNIVERSITY