LaGia Mack (Davis) MS, CCRA, CCRP

Experience

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  Mid Carolina Cardiology

  Jan 2006 - Oct 2006

  Certified Cardiovascular Tech

  Administered exercise and pharmacological stress testsApplied Advanced Cardiac Life Support (ACLS) measured to patients when directedPrepped patient for stress testing procedure-including patient interview, obtaining medical history, and obtaining patient consent and signaturesAssessed patient’s blood pressures, pulse respirations, lung sounds, and established peripheral intravenous accessSet up and monitored patients through 12 lead ECG stress testingECG rhythm identification and interpretationAssisted with patient prescription refill and lab result calls Show less

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  Duke University

  Oct 2006 - May 2009

  Senior Clinical Exercise Physiologist

  Administered all aspects of clinical diagnostic cardiovascular and pulmonary testing: Exercise Tolerance, Stress Echo, Medicated Stress, Level and Level 3 Cardiopulmonary, Pulmonary Function, Non-invasive Lower Extremity Arterial, ambulatory Blood Pressure, and Holter/Loop MonitoringECG preparation and interpretationPrepped patients for stress testing procedure-including patient interview, obtaining medical history, and obtaining patient consent and signaturesEstablished peripheral intravenous access for use of contrast agents and agitated salineRecognized symptom changes/signs of problems and administered the appropriate medical response and processes. Initiated first responder careCollected, processed and interpreted data for physician reportsParticipated in the collection of data for clinical research Show less

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  Duke Clinical Research Institute

  May 2009 - Apr 2021

  Participate in the development of protocol, documentation and standard operating procedures for monitoring the clinical trials, evaluate alternative approachesProvide input into the development of the CRF design and completion instructions, site materials, query rules and resolution process, and related data tools and status reportsDevelop and implement Clinical Monitoring Plan, Data Entry Guidelines, and CTMS protocol setupEstablish and maintain tracking tools for assigned trialsProvide site management and clinical monitoring expertise, and leadership to assigned team. Provide advice and guidance to team members for assessment, resolution, and documentation of both routine and complex site and study issues.Provide training and ensure all team members are current with their required study-specific trainingIdentify resource needs and supervise team members’ work assignments, utilization and productivity. Collaborate with project leadership to evaluate impact on resource needsDirect and prioritize team efforts and asses overall team progress against study timelines and metricsReview and approve team deliverables focusing on quality and timeliness of all monitoring activities within the defined scope of workConduct regular team meetings to assess project status and mitigate emerging or potential risksProvide oversight and manage the day to day tasks of Clinical Research Associates, Clinical Trial Coordinators, and Clinical Trial SpecialistsProvided day to day oversight of monitoring activities, data review and quality, and compliance to protocols and GCPComplete co-monitoring visits to ensure oversight, data integrity, and determine compliance with approved protocols, GCP, and applicable regulations Show less Support the development, coordination and implementation of monitoring and administrative strategies essential to successful management of all phases of multi-site research projects Participate in site selection and training site personnel regarding the trial; perform site monitoring duties and follow-up to ensure identified deficiencies are corrected; travel as required inside and outside of the USA to accomplish responsibilitiesParticipate in the development of protocols, informed consent forms, case report forms (CRFs) and instructions, site selection materials, procedure/in service manuals, project newsletter, project specific standard operating procedures, and other monitoring tools for the clinical trialFollow established guidelines in the collection of clinical data and/or administration of clinical trialsAssist in assessing the suitability of potential investigative sites through telephone screening interviews, regulatory document review and disseminating clinical trial information; conduct site qualification visits to determine adequacy of facilities and staff, patient recruitment and retention potential, ability to comply with regulatory requirements, and overall interest and commitment of principal investigator to conduct and complete the planned clinical studyConduct site initiation visits as needed for the purpose of training site personnel about the protocol, study procedures, patient recruitment and retention requirements, regulatory requirements, CRF completion and retention requirements, drug accountability procedures, and serious adverse events (SAEs) reporting procedures, and overall managementConduct monitoring visits to assure the integrity of clinical data with respect to accuracy, accountability, documentation, and methods or procedures through review of CRFs, source documents, medical records, and regulatory documentsProvide feedback to assigned sites and information regarding detected deficiencies and corrective action needed Show less Support the development, coordination and implementation of research and administrative strategies essential to successful management of all phases of multi-site research projects Build strong working relationships with project stakeholders to exceed project expectations while assisting the project manager to ensure the project remains within scope, on time, within budget and with high quality processes and deliverablesCollaboratively work with required functional groups and faculty to ensure success throughout the project lifecycleProactive communication with international and domestic investigator sites to ensure successful site management from project start-up through site close-outDraft and finalize a variety of reports, documents and correspondence for participating clinical trials sites Develop reports, metrics and key performance indicators (KPIs) for internal purposes to assist in the ongoing monitoring and evaluation of the clinical trials processesAssist project team in the development of project communication plans, project management plans, internal process documents, and clinical protocolsAssist Project Managers in tracking milestones and billing, reviewing invoices, pass-through costs and time billed to projects for accuracy in accordance with contract termsEnsure distribution of appropriate forms, supplies, and equipment to investigator sites Develop, review and update project timelines on a routine basis to ensure timely progress and completion Train and oversee Clinical Trial Assistants in the receipt and dissemination of project materialsResponsible for chairing project team meetings and for the timely generation and distribution of meeting agendas and minutesEfficiently track and communicate project progress against project milestones Assist in analysis of Imaging data of multi-site clinical trialsProficient in the use of electronic data capture (EDC) systems including RAVE, InForm and eCOS Show less

  • Lead CRA

    Jan 2020 - Apr 2021

  • Clinical Research Associate III

    Apr 2017 - Jan 2020

  • Clinical Research Associate II

    Nov 2015 - Apr 2017

  • Clinical Research Associate

    Nov 2014 - Nov 2015

  • Clinical Trials Coordinator

    May 2009 - Nov 2014
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  IQVIA

  Apr 2021 - now

  Manager, Clinical Operations, IQVIA MedTech

  Work with Clinical Operations Management staff to ensure the successful management, performance, and career development of Clinical Research Associates (CRAs) and Clinical Trial Assistants (CTAs)Participate in the selection for hiring new employees by conducting candidate review and participating in the interviewing processCommunicate with the Project Managers (PMs) as needed, to ensure correct monitoring resources per projectLiaise with PMs to ensure monitoring deliverable/targets are met, ensure project hours are met, ensure excessive hours are noted and action taken as necessaryEnsure any project issues and results of discussions with PMs are escalated appropriatelyParticipate in the allocation of resources to clinical research projects by assigning staff to clinical studies based on their experience and trainingConduct field evaluation visits with staff at sitesHold regular one-on-one meetings with staff to discuss performanceEnsure training record compliance with training matrix and ensure training records are up to date; assist with coordination and implementation of on-boarding of new direct reportsEnsure that staff has the proper materials, systems access and training to complete job responsibilitiesMaintain awareness of overall development in the field of clinical research and ensures that staff remain current on clinical monitoring developments Show less