Mallory Giza's Email Addresses & Phone Numbers

📖 Summary

Advocacy Operations Assistant @ Kids House of Seminole Kids House serves as a one-point contact for victims of child abuse within Seminole County, Florida. Children enter into a child-friendly environment where they feel safe to tell their story and receive much needed services including therapy and medical exams. Child advocates are assigned to each case and help to walk their clients through the entire process. From July 2007 to April 2009 (1 year 10 months) Licensed Professional Counseling Associate @ AHB Psychological Services • Facilitated of individual counseling sessions utilizing a person-centered CBT approach to treat anxiety, depression, stress symptoms, Attention-Deficit/Hyperactivity Disorder, and self-esteem concerns. From March 2012 to October 2012 (8 months) Durham, NCClinical Research Associate II @ IQVIA • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and goodclinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites tomanage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence toapplicable regulations.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment,case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans bysubmitting regular visit reports and other required study documentation.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. Raleigh-Durham, North Carolina AreaSenior Clinical Research Associate @ IQVIA • Perform site selection, initiation, monitoring and close-out visits in accordance with contracted scope of work and goodclinical practice.• Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites tomanage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence toapplicable regulations.• Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment,case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans bysubmitting regular visit reports and other required study documentation.• Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. From August 2018 to July 2019 (1 year) Clinical Research Associate @ IQVIA • Performed site initiation, monitoring and close-out visits in accordance with contracted scope of work and goodclinical practice.• Provided monitoring visits and site management for a variety of protocols, sites and therapeutic areas.• Administered protocol and related study training to assigned sites and establish regular lines of communication with sites tomanage ongoing project expectations and issues.• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence toapplicable regulations.• Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment,case report form (CRF) completion and submission, and data query generation and resolution.• Created and maintain appropriate documentation regarding site management, monitoring visit findings and action plans bysubmitting regular visit reports and other required study documentation.• Administered protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues.• Evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. • Managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution.• Created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports and other required study documentation. From January 2016 to April 2017 (1 year 4 months) Southeast USClinical Research Associate, Trainee @ IQVIA • Completed appropriate therapeutic, protocol and clinical research training per the established Early Talent Training roadmap to perform job duties.• Gained experience in study procedures by working with experienced clinical staff in Clinical Research Associate (CRA), Clinical Research Specialist (CRS) and Clinical Trials Assist (CTA) roles. May also work collaboratively with other functional groups such as Data Management and Pharmacovigilance.• Under close supervision, performed site selection, initiation, monitoring and close out visits in accordance with contracted scope of work and good clinical practices.• Under close supervision, administered protocol and related study training to assigned sites and establishes regular lines of communication with sites to manage ongoing project expectations and issues.• Under close supervision, evaluated the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), CRS and/or line manager.• Under close supervision, managed the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, Case Report Form (CRF) completion and submission, and data query generation and resolution.• Under close supervision, created and maintained appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation. From October 2015 to January 2016 (4 months) Clinical Trial Assistant @ IQVIA • Assisted Clinical Research Specialist , Clinical Research Associates (CRAs), and Regulatory and Start-Up (RSU) with accurately updating and maintaining clinical systems that track site compliance and performance within project timelines.• Assisted the clinical team in the preparation, handling, distribution, filing, and archiving of clinical documentation and reports according to the scope of work and standard operating procedures. Assist with periodic review of study files for completeness.• Assisted CRS, CRAs, and RSU with preparation, handling and distribution of Clinical Trial Supplies and maintenance of tracking information.• Assisted with the tracking and management of Case Report Forms (CRFs), queries and clinical data flow.• Acted as a central contact for the clinical team for designated project communications, correspondence and associated documentation.• Accompanied CRAs on site visits to assist with clinical monitoring duties• Performed additional assigned administrative tasks to support team members with clinical trial execution.*GCP Certified 2015 From June 2014 to October 2015 (1 year 5 months) RTPClinical Research Assistant @ Duke University • Gained and maintained IRB approval for documents necessary for study progression• Initiated and followed up with eligible participant recruitment• Established informed consent with participant and participating family members• Served as primary resource for participants throughout the study• Conducted structured clinical interview with participant and participant guardian(s)• Prepared clinical questionnaires and related paperwork for participant completion• Received and prepare participant payment forms for timely reimbursement• Coordinated with other study sites to maintain uniformity and open communication• Assisted with organization and preparation for study audit• Maintained updated binder for each participant, including updated informed consents, updated contact information, reimbursement forms, and appropriate documentation detailing each participant interview. • Provided quality assurance with respect to collected data • Coordinated with data analyst for quality assurance with respect to submitted data• Responded to data queries in timely manner• Collaborated with study PI, coordinator, and clinicians regarding participant needs and appropriate service referrals and overall study management From August 2013 to June 2014 (11 months) Raleigh-Durham, North Carolina AreaPsychometrist; Licensed Professional Counselor Associate @ NC Neuropsychiatry • Provision of psychological and neuropsychological assessments with child, adult, and geriatric populations. Assessments include: intelligence, academic achievement, personality, mood, dementia, brain trauma, language, motor coordination, visuo/spatial, memory, and effort• Evaluations include Worker’s Compensation and Independent Medical Evaluations• Trained doctoral candidates from Duke University in administration and scoring of neurosychological assessments• Recorded clinical behavioral observations • Scored assessment data and wrote data summaries• Collaborated with patient providers and case managers• Interviewed patients for neuropsychiatric history intake From July 2011 to June 2014 (3 years) Raleigh-Durham, North Carolina AreaRehabilitation Conseling and Psychology Intern @ North Carolina Neuropsychiatry •Provision of >640 hours of client contact with both adults and children, including individual counseling sessions utilizing a person-centered CBT approach to treat anxiety, depression, stress symptoms, complex trauma, Attention-Deficit/Hyperactivity Disorder and Oppositional Defiant Disorder• Neuropsychiatric history intakes• Administering Woodcock Johnson III Tests of Achievement• Monitoring Cognitive Rehabilitation with patient with TBI• Completion of comprehensive psychological evaluation reports From April 2011 to July 2011 (4 months) Raleigh, NCResearch Assistant @ University of North Carolina at Chapel Hill • Co-authored publications in peer-reviewed journals• Recruited EMS county participants and managed consenting process• Data entry: qualitative and quantitative• Maintained IRB approval• Assisted with educational presentation delivery• Conducted Literature reviews• Created & distributed research questionnaires From May 2010 to April 2011 (1 year) Raleigh-Durham, North Carolina AreaGradaute Assistant @ University of North Carolina at Chapel Hill • Researched and constructed literature reviews on topics related to counseling those with medical issues and disability with an emphasis on lung transplant candidates and recipients• Drafted patient psychological evaluation reports• Recruited diverse populations for RCP department• Prepared professor materials for class instruction From August 2009 to May 2010 (10 months) Chapel Hill, NCRehabilitation Counseling and Psychology Practicum @ North Carolina Neuropsychiatry • Provision of >128 hours of services to consumers with disabilities including neuropsychiatric intake interviews; individual counseling utilizing a person-centered CBT approach to treat anxiety, depression, stress symptoms, Attention-Deficit/Hyperactivity Disorder and Oppositional Defiant Disorders• Conducted psychological assessments, including the Woodcock Johnson III Tests of Achievement• Authored comprehensive psychological evaluation reports From August 2010 to December 2010 (5 months) Raleigh, NCSenior Site Manager @ IQVIA From July 2019 to July 2020 (1 year 1 month)