Clinical Study Manager

• Jan 2023 - Present

Associate Study Manager

• Feb 2022 - Jan 2023

· Provides guidance to CRAs and CRCs in the planning, implementation, and closeout of clinical research projects. Serves as a point of contact for issue escalation. · Develops key study documents, including but not limited to, Clinical Management Plans, Monitoring Plans, Informed Consent Forms, Case Report Forms, Study Reference Manuals/Regulatory Binders and source document templates · Reviews or designates review of monitoring trip reports · Manages vendors, including the… Show more · Provides guidance to CRAs and CRCs in the planning, implementation, and closeout of clinical research projects. Serves as a point of contact for issue escalation. · Develops key study documents, including but not limited to, Clinical Management Plans, Monitoring Plans, Informed Consent Forms, Case Report Forms, Study Reference Manuals/Regulatory Binders and source document templates · Reviews or designates review of monitoring trip reports · Manages vendors, including the implementation and coordination of vendor’s Scope of Work (SOW) · Serves as a study contact for Sponsor and project vendors · Idnetifies, resolves, or escalates issues involving study timelines and deliverables · Assist with developing, implementing, and overseeing enrollment plans and strategies · Supports with overseeing system development, ensuring suitable fit for the protocol · Collects, tracks and reports established Key Performance Indicators such as query resolution, safety data collection or issues, drug reconciliation/shipment, site and patient enrollment, protocol deviations · Identifies and establishes the suitability of study investigators and their investigative sites and liaises with them to ensure compliance with all necessary study requirements, approvals and agreements (e.g. financial and confidential) · Ensures study conduct in accordance with appropriate SOPs, ICH/GCP Guidelines and local regulations · Reviews and approves proposed study change orders while monitoring ongoing study budgets and SOWs

Senior Project Specialist

• Jun 2021 - Feb 2022

Acting Clinical Surveillance and Training (CST) Project Manager on numerous studies; tasks include o Study team management, delegation of tasks, analysis of team member allocations and FTE to determine projected resourcing o Study budget management with review of current budget allocations, proposed changes for upcoming change orders to capture services identified as out of scope; creation of purchase orders, procured study scale licensing contracts o Attended several… Show more Acting Clinical Surveillance and Training (CST) Project Manager on numerous studies; tasks include o Study team management, delegation of tasks, analysis of team member allocations and FTE to determine projected resourcing o Study budget management with review of current budget allocations, proposed changes for upcoming change orders to capture services identified as out of scope; creation of purchase orders, procured study scale licensing contracts o Attended several sponsor-facing meetings including Kick Off Meetings and weekly calls to discuss study start-up activities o Communicated consistently with other functional areas to discuss timelines, action items, key risks and resolving issues in a timely manner while preserving service quality and sponsor expectations o Coordinated and maintained fluid communication with other functional areas to ensure all items needed for study start-up are addressed within all specified project timelines o Creation of several study-specific plans, including Clinical Surveillance and Training Plan (CSTP), Rater Training Plan (RTP) and Eligibility Review Plan (ERP) for sponsor review and approval · Hosted internal project team meetings to discuss study budgets, site statuses, and other weekly updates, assigned action items to relevant team members to ensure delivery of sponsor deliverables · Escalated all issues in a timely manner to relevant Project Directors, other Project Managers and other functional area leads · Served as main point of contact within CST for other functional areas for specified studies · Mentored numerous Project Specialists during onboarding and acclimation within Clinical Surveillance and Training (CST) as well as study-specific tasks and responsibilities

Project Specialist

• Apr 2019 - Jun 2021

Clinical Surveillance and Training (CST) Project Specialist responsible for administrative support including but not limited to rater training, scales management and translation, screening eligibility review, and endpoint review · Assisted study Project Managers with internal CST meetings, providing timely information and updates for all team members as well as recorded accurate meeting minutes for team distribution · Hosted daily meetings with numerous sponsor teams to discuss ongoing… Show more Clinical Surveillance and Training (CST) Project Specialist responsible for administrative support including but not limited to rater training, scales management and translation, screening eligibility review, and endpoint review · Assisted study Project Managers with internal CST meetings, providing timely information and updates for all team members as well as recorded accurate meeting minutes for team distribution · Hosted daily meetings with numerous sponsor teams to discuss ongoing site statuses and patient eligibility · Provide support for quality assurance activities, including preparation for audits and internal review, prepare documentation and follow through to resolution on actionable issues · Ensured fluid communication with sponsors, investigative sites, site monitors, and other cross- functional groups, escalating any issues as they may arise in a quick and professional manner · Maintained and distributed study-specific reports (site rater-readiness, screen failure and enrollment rate metrics, etc.) · Owner of four study-specific shared mailboxes, responsible for ensuring all requests and action items addressed in a timely manner · Conducted training sessions for sites conducting their first patient screens to ensure familiarity with all CST processes and expectations for Eligibility Review and Therapeutic Logic Checks over the course of the study

Clinical Trial Assistant

• Aug 2018 - Apr 2019

· Maintained an audit-ready eTMF by streamlining communication from site to CRA, collecting and quality checking site and country-specific documentation and updating clinical systems all to ensure site and country compliance within project timelines · Prepared, distribute, and file clinical reports, documentation, meeting minutes and supplies for tracking information and site use (internal and external) and provide consistent follow up communication to close action items in a timely… Show more · Maintained an audit-ready eTMF by streamlining communication from site to CRA, collecting and quality checking site and country-specific documentation and updating clinical systems all to ensure site and country compliance within project timelines · Prepared, distribute, and file clinical reports, documentation, meeting minutes and supplies for tracking information and site use (internal and external) and provide consistent follow up communication to close action items in a timely manner · Acted as central contact and provide administrative support for clinical study team and other internal departments for all project communication and correspondence to ensure project timeliness, completeness, and accuracy · Assisted peers with study TMF platforms such as Wingspan, CTMS, DrugDev, etc. Show less · Maintained an audit-ready eTMF by streamlining communication from site to CRA, collecting and quality checking site and country-specific documentation and updating clinical systems all to ensure site and country compliance within project timelines · Prepared, distribute, and file clinical reports, documentation, meeting minutes and supplies for tracking information and site use (internal and external) and provide consistent follow up communication to close action items in a timely… Show more · Maintained an audit-ready eTMF by streamlining communication from site to CRA, collecting and quality checking site and country-specific documentation and updating clinical systems all to ensure site and country compliance within project timelines · Prepared, distribute, and file clinical reports, documentation, meeting minutes and supplies for tracking information and site use (internal and external) and provide consistent follow up communication to close action items in a timely manner · Acted as central contact and provide administrative support for clinical study team and other internal departments for all project communication and correspondence to ensure project timeliness, completeness, and accuracy · Assisted peers with study TMF platforms such as Wingspan, CTMS, DrugDev, etc. Show less

Manufacturing Associate

• Jun 2017 - Aug 2018

· Work collaboratively in a team environment to ensure accurate processing steps as defined by SOPs and BPRs · Operate aseptically to efficiently propagate MDCK cell growth and virus seed production · Analyze LIMS EM (Environmental Monitoring) data to ensure quality while processing aseptically · Document results accurately and in accordance with cGMP and GDP · Perform cleaning and preparation procedures for next batch use · Communicate efficiently with other departments… Show more · Work collaboratively in a team environment to ensure accurate processing steps as defined by SOPs and BPRs · Operate aseptically to efficiently propagate MDCK cell growth and virus seed production · Analyze LIMS EM (Environmental Monitoring) data to ensure quality while processing aseptically · Document results accurately and in accordance with cGMP and GDP · Perform cleaning and preparation procedures for next batch use · Communicate efficiently with other departments regarding process results and records · Maintain, request, and submit documentation via EDMS, ensure training is current Show less · Work collaboratively in a team environment to ensure accurate processing steps as defined by SOPs and BPRs · Operate aseptically to efficiently propagate MDCK cell growth and virus seed production · Analyze LIMS EM (Environmental Monitoring) data to ensure quality while processing aseptically · Document results accurately and in accordance with cGMP and GDP · Perform cleaning and preparation procedures for next batch use · Communicate efficiently with other departments… Show more · Work collaboratively in a team environment to ensure accurate processing steps as defined by SOPs and BPRs · Operate aseptically to efficiently propagate MDCK cell growth and virus seed production · Analyze LIMS EM (Environmental Monitoring) data to ensure quality while processing aseptically · Document results accurately and in accordance with cGMP and GDP · Perform cleaning and preparation procedures for next batch use · Communicate efficiently with other departments regarding process results and records · Maintain, request, and submit documentation via EDMS, ensure training is current Show less

Quality Control Laboratory Technician

• May 2016 - Jul 2017

· Managed time effectively with multiple projects to ensure quick turnaround of results · Introduced Lean Six Sigma practices within the laboratory for increased productivity and waste elimination · Communicated top priorities to team at the beginning of each shift to ensure efficiency · Followed SOPs to ensure quality control standards · Researched and identified discrepancies between working data and benchmark data using LIMS · Performed calibrations on lab equipment to… Show more · Managed time effectively with multiple projects to ensure quick turnaround of results · Introduced Lean Six Sigma practices within the laboratory for increased productivity and waste elimination · Communicated top priorities to team at the beginning of each shift to ensure efficiency · Followed SOPs to ensure quality control standards · Researched and identified discrepancies between working data and benchmark data using LIMS · Performed calibrations on lab equipment to ensure accuracy and meet relevant KPIs · Handle and dispose of hazardous chemicals and byproducts to promote laboratory safety Show less · Managed time effectively with multiple projects to ensure quick turnaround of results · Introduced Lean Six Sigma practices within the laboratory for increased productivity and waste elimination · Communicated top priorities to team at the beginning of each shift to ensure efficiency · Followed SOPs to ensure quality control standards · Researched and identified discrepancies between working data and benchmark data using LIMS · Performed calibrations on lab equipment to… Show more · Managed time effectively with multiple projects to ensure quick turnaround of results · Introduced Lean Six Sigma practices within the laboratory for increased productivity and waste elimination · Communicated top priorities to team at the beginning of each shift to ensure efficiency · Followed SOPs to ensure quality control standards · Researched and identified discrepancies between working data and benchmark data using LIMS · Performed calibrations on lab equipment to ensure accuracy and meet relevant KPIs · Handle and dispose of hazardous chemicals and byproducts to promote laboratory safety Show less

Stand Manager

• Dec 2009 - May 2017

Responsible for multiple employees, cash, and inventory while catering events in and around the Raleigh area such as concerts at Red Hat Amphitheater and local university sporting events. Responsible for multiple employees, cash, and inventory while catering events in and around the Raleigh area such as concerts at Red Hat Amphitheater and local university sporting events.