Summary
Overview
Work History
Education
Skills
Timeline
Generic

Lindsey Alexander

San Antonio

Summary

Research Professional with twenty years' experience as a CTM, CMA, CRA, Study Coordinator, Protocol Coordinator and Lab Research Assistant. Primary indications in research include asthma, multiple sclerosis, psoriasis, oncology, diabetes, surgical devices, cluster headaches and migraines. Proven leadership qualities, exhibits enthusiasm and self-motivation. Detail oriented and proficient in documentation and data reporting within timelines and regulations. Part of start up team of the Central Monitoring Associate Program at ICON.

Overview

20
20
years of professional experience

Work History

Clinical Operations Lead

Parexel
03.2023 - Current
  • Lead the clinical aspect of the trial and liaison to the Project Leader
  • Manage day to day operations and Clinical Research Associates
  • Ensure Clinical Operations deliverables, timelines and productivity are met
  • Create an maintain Clinical Monitoring Plan, Project Management Plan, Informed Consent Forms, Trainings
  • Ensure Trial Master File are in compliance with applicable local regulatory requirements and ICH guidelines.
  • Work directly with Data Management on data integrity and trends
  • Fostered a positive work environment by promoting open communication, teamwork, and employee engagement.
  • Led project teams through all phases of implementation, from initial planning to final execution, ensuring successful completion within defined timelines.

Clinical Lead II

Premier Research
03.2022 - 03.2023
  • Drives the successful activation of trial sites according to time, quality/scope and budget parameters.
  • Plans and drives both patient recruitment and retention together with the Project Manager, inclusive of preparing and executing a site and patient recruitment and retention plan/strategy to motivate recruitment in order to meet milestones
  • Works cross functionally to deliver project deliverables with Project Manager, Data Managers,Clinical Monitoring Services team
  • Create and maintain a study specific clinical monitoring plan utilizing approved templates; ensure effective communication and escalation instructions are incorporated in the CMP and actioned appropriately
  • Leads, manages and actively monitors the clinical monitoring team with a focus on quality and timely deliverables; addressing any issues with the appropriate team member and their line manager ·
  • Ensures the timely completion of all visit reports, reviews them for appropriate content to ensure quality, GCP compliance, finalization within contractual timeline and effective follow up and resolution of site issues
  • Ensures timely data verification through review of data management reports and use of monitoring resources to optimize monitoring of clinical data
  • Collaborates with Project Manager to establish clinical project timelines and accomplish all milestones throughout the study
  • Contribute to the risk management plan and contribute to set up of adaptive risk monitoring system
  • Work with Project Management and Financial Analyst to accurately forecast clinical tasks including monitoring visits
  • Contribute to the creation, review and finalization of Root Cause Analysis and CAPA

Clinical Trial Manager

PRA Health Sciences / ICON
05.2021 - 10.2021
  • Plans and leads execution of the day to day activities for the monitoring of a clinical study and communicates consistently with the clinical team providing project objectives, expectations and status updates.
  • Works with the relevant staff to identify data related issues and risks to clinical activities; develops contingency and mitigation plans to minimize risks.
  • Oversees transition plans to allow seamless transition of knowledge in case of CTM or clinical team member replacement.
  • Leads and manages the start-up and clinical teams.
  • Identifies out-of-scope tasks from clinical team and escalates as required.
  • Interfaces with other Functional Leads, vendors and client as required to ensure clinical monitoring outcomes are achieved.
  • Creates and maintains project specific plans, documents and tools for the clinical team.
  • Reviews and approves site visit reports within agreed turnaround times and ensures tracking, follow up and resolution of site issues.
  • Analyzes data related to sites activation, monitoring, data retrieval and close out to identify issues and risks to clinical deliverables; develops contingency and mitigation plans to minimize risks; communicates risks & mitigation strategies
  • Monitors the quality of clinical deliverables and addresses quality issues with the appropriate team member

Central Monitoring Associate II

PRA Health Sciences / ICON
09.2016 - 05.2021
  • Initiated Central Monitoring Associate position at PRA Health Sciences along with 5 other colleagues
  • Designed the position and implement SOPS on how Risk Based Monitoring should be conducted
  • Trained sites and CROs on Risk Basked Monitoring
  • Responsible for clinical project delivery with regards to agreed time, scope, cost and quality
  • Key clinical deliverables include but are not limited to: Patient recruitment and retention, Ensuring the clinical project team is resourced effectively, Agile management of the Monitoring Visit Strategy, Management of SDV burden, Clinical vendor delivery, Management of clinical deliverables related to protocol endpoints
  • Responsible for leading clinical deliverables
  • Serve as escalation point for clinical project issues, within area of project responsibility, to internal and external stakeholders, as appropriate
  • Serve as key client contact for assigned project responsibilities, establishing working relationships with client project teams which result in client satisfaction, operational excellence and thereby increase potential for repeat business

Clinical Research Associate

PRA Health Sciences/ ICON
09.2015 - 09.2016
  • Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH-GCP guidelines
  • Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close clinical trials at investigative sites
  • Achieved project-specific quality and performance standards and provided documentation and communication
  • Attained clinical study sponsorships and communicated with sponsor representatives
  • Reviewed the site regulatory binder to check collection procedures and completeness of paperwork Attended investigator meetings to provide framework for successful research studies by establishing responsibilities
  • Adhered to good clinical practices, operating procedures and regulatory requirements.

Research Coordinator

Allergy and Asthma Research Center
08.2009 - 09.2015
  • Responsible for patient screening, recruitment, consent, and enrollment for 8 of ongoing clinical research projects
  • Managed all follow-up and case report completion of study and patient specific data in order to maintain source documentation necessary for drug/device accountability
  • Personally responsible for obtaining patient/study-related data to include non-invasive and minimally invasive procedures such as lab draws and spirometry
  • Maintain HIPAA compliance at all times
  • Accountable for all necessary regulatory documentation required for FDA and other governing agencies
  • Managed the accurate and timely processing of up to 3-4 protocols per month for Astrazeneca, Teva, Genetech, and Sanofi Aventis pharmaceutical and many more
  • Trained new staff clinical research coordinators and served as the primary "go-to" troubleshooter on new protocols, which propelled efficiency gains and significant time- and cost-savings
  • · Facilitated internal and external maintenance of protocols as a result of sound recordkeeping and thorough patient documentation

Protocol Research Coordinator

US Army Institute For Surgical Research
11.2008 - 07.2009
  • Organize and prioritize all activities associated with documentation of phase 1, 2 and 3 studies within a military setting
  • Reviewed protocol documentation to ensure applicable regulations and guidelines were followed
  • Provided documentation, to include gathering, preparing and maintaining appropriate information per applicable FDA regulations and ICH guidelines, source and case report forms, SOPs, continuing review, protocol and regulatory documentation for Institutional Review Board (IRB) submission
  • Performed forms and reports necessary for quality assurance of all clinical research activities

Medical Assistant / Research Coordinator

DGD Research
07.2005 - 11.2008
  • Responsible for patient screening, recruitment, consent, and enrollment for 8 of ongoing clinical research projects
  • Managed all follow-up and case report completion of study and patient specific data in order to maintain source documentation necessary for drug/device accountability
  • Personally responsible for obtaining patient/study-related data to include non-invasive and minimally invasive procedures such as lab draws and spirometry
  • Accountable for all necessary regulatory documentation required for FDA and other governing agencies.

Education

Bachelor of Science -

Wayland Baptist University
Plainview, TX
09-2015

Skills

  • FDA/Government Regulation
  • Clinical Research Monitoring
  • MS Office: Word, Excel, PowerPoint, Outlook
  • Protocol Development and Maintenance
  • Quality Assurance
  • Risk Based Monitoring
  • Policy and Protocol Oversight
  • Clinical Staff Oversight
  • Trial Management
  • Workflow Processess
  • Strong team building skills
  • Organizational skills

Timeline

Clinical Operations Lead

Parexel
03.2023 - Current

Clinical Lead II

Premier Research
03.2022 - 03.2023

Clinical Trial Manager

PRA Health Sciences / ICON
05.2021 - 10.2021

Central Monitoring Associate II

PRA Health Sciences / ICON
09.2016 - 05.2021

Clinical Research Associate

PRA Health Sciences/ ICON
09.2015 - 09.2016

Research Coordinator

Allergy and Asthma Research Center
08.2009 - 09.2015

Protocol Research Coordinator

US Army Institute For Surgical Research
11.2008 - 07.2009

Medical Assistant / Research Coordinator

DGD Research
07.2005 - 11.2008

Bachelor of Science -

Wayland Baptist University

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Lindsey Alexander