Clinical Project Manager & QA Specialist
Resume:
TAUSHA L. DORSEY
Garner, NC *****
******.******@*****.*** www.linkedin.com/in/taushadorsey/
CLINICAL PROJECT MANAGER/CLINICAL MONITORING/ QA/ FACILITY & HOME HEALTHCHARE
Drug Development Process/ Clinical assessment skills/ personal Healthcare
High performing Project Management professional with over 15 years of experience managing and directing highly complex clinical projects within the clinical research organizations (CRO) and biopharmaceutical industries. Successfully manages the full life cycle of clinical projects utilizing critical thinking, time management and logical planning skills to meet milestones and deliverables according to project scope, cost and performance goals. Clinical Monitoring of 22+ sites, independent travel, training, report writing in a timely manner. Independently prepare protocols, summarizing information relating to schedule, budget, resources and timely contract services. Strong communication skills (written/oral) and the ability to establish key relationships with senior management, clinical operations and all other staff members and clients involved in the trial process. Supervised 20+ employees at assisted living facility for 64 patients (AL/Dementia and Well), trained PCA and Medication Aides. Specialize in Memory Care.
Supervisor/PCA trainer/Registered Medication Aide/CPR Certified
Over 15 years managing and training highly complex projects and deadlines.
Over 10 years of SharePoint and Salesforce Experience
Over 15 yrs of MS Word, MS Project, Power Point experience
Over 25 years of customer service and building great working relationships internal and externally. Great team player!
Phase I – IV Clinical Trial Process
Clinical Trial Management Systems
Resource Management
Healthcare facility Supervisor
Multi-Site & Multi-Project Operations
Mentoring & Training
Specialize in Memory Care
Cross-Functional Project Team Leadership
Time Management
MEDICAL & PROJECT MANAGEMENT TECHNICAL EXPERTISE
Oracle Clinical/ SQL/ Lawson, Oracle PL, Infolink, Inform, Medidata Rave, CTMS, Nextdocs, SharePoint, Veracity, SAS, MyEDC Electronic Data Capture System, Microsoft Word, Excel, Access, PowerPoint and Project. UAT Systems, SQL/TOAD, SOUNDFORGE, Gantt charts and other tracking/analysis tools, IVR Systems, Credisoft, Clinpay systems, Sales Force, Calabrio
KEY PROJECT MANAGEMENT/SITE MONITORING/QUALITY ASSURANCE SKILLS
Expert in leading core project management activities with full-service studies, including managing project goals, opportunities, resources, timelines, financial expenditures, validation testing and metrics to meet milestones and deliverables according to project scope.
Manage directly with sponsors, vendors, sites and functional team members while measuring performance.
Software, Platform and Manual validation testing for internal and vendors.
Training all internal and external staff to include sponsors, clients, CRAs, sites, vendors and investigator meetings.
Manage weekly and monthly meetings with CRAs, CTMs and Coordinators regarding sites and study parameters to meet project needs and goals.
Visit sites and complete all site visit reports.
Oversee site enrollment metrics, CRA metrics, assignments, training, resources and assistance and determine site selection based on study and client metrics.
Participate in the design, writing, and review of all project-related documents including budgets and proposals, contracts and change orders, protocols, informed consent, case report forms, statistical analysis plans, data management plans, clinical monitoring plans and clinical study reports.
Structuring / running projects to yield the following measurable results:
Quicker time to market potential and productivity gains through improved communication using multiple strategies, transparent and clear processes and tools.
Cost reductions through thorough schedule adherence, budgeting, resourcing management and a focus on the oversight of third-party contractors.
Quality delivery of study.
PROFESSIONAL EXPERIENCE
NC State University Apr 2026- current
Campus Health Administrator
Provide professional front-line support to patients, students, and visitors by assessing routine and time-sensitive service needs, coordinating intake, and ensuring accurate completion of clinical documentation. Maintain confidential patient information within Electronic Medical Records (EMR), scheduling, and administrative systems while managing high-volume telephone and in-person inquiries. Coordinate appointments, calendars, patient routing, and daily administrative workflows to support efficient clinical operations and continuity of care. Collaborate with healthcare providers and administrative teams to address patient needs and resolve scheduling or documentation concerns while maintaining compliance with HIPAA, FERPA, OSHA, university policies, and established clinical protocols.
NC Central University (Contract) Aug 2025- Jan 2026
Research Assistant/Project Coordinator
Managing research activities, coordinating grant-funded projects, analyzing data, and collaborating with faculty/community partners, often with a focus on health disparities, digital equity, or academic success.
Strayer University June 2021-July 2024
Student Advisor Coach
Responsible for providing personalized guidance and support to students throughout their academic journey, helping them navigate course selection, academic planning, financial aid, and potential challenges to ensure they successfully reach their graduation goals by proactively advising assigned students through various communication channels like phone, email, and text. Recruit and monitor students for Fellows for Justice Scholarship program in the Charlotte, Raleigh and surrounding areas.
Trial card (Aerotek/Contract) Oct 2020- April 2021
Case Management QC Analyst
Monitor and review quality of customer interactions and service inquiries received by the program coordinator for areas of opportunities and adherence to program requirements.
Train call center and QC staff on study parameters, (Therapeutic area, drug, expectations etc.)
Captures in detail opportunities for improvement
Assist supervisors and managers with training and refresher courses
Monitors operations to ensure adherence to service level standards, exceptional customer experience, and program policies and procedures.
Responsible for evaluating the quality of calls from customers and capturing feedback for reps on strength and areas of improvement.
Write research questionnaires.
Maintains monitoring scorecard and feedback for team
Identifies opportunities outside procedural structure and recommends procedural changes requiring management approval to implement.
Vada Hall24/hour Care Feb 2020- March 2020
PCA
•Personal care for elderly with health issues (Alzheimer’s/Dementia and Cardiovascular) to include:
• Assistance patients throughout home, bathroom, bed, etc. Food prep and/or assist with food delivery choices based on allergies, medication etc.
Covance (Aerotek) January 2020- Feb 2020
Adjudication Assistant II
Perform Assessment of safety and efficacy of pharmacological documentation for 42 sites
Contacting Investigator Sites according to protocol requirements to obtain documents and study related discharge summaries, site narratives, ECG, Echocardiograms etc….to review and assess clinical trials endpoints of adverse events.
Monitors activities at clinical study sites to assure adherence to GCP, ICH, SOPs, and study protocols to include reviewing and collecting regulatory documents; preparing site visit reports and telephone contact reports; resolving site issues, including site recruitment challenges, and determines status for IP shipment.
Support EDC Review and Data Entry Requirements
IQVIA (Aerotek) January 2019-Nov 2019
Regulatory Specialist 1 (Contract)
Perform tasks at country level associated with Regulatory, Start-up and Maintenance activities in accordance with applicable local and/or international regulations, standard operating procedures (SOPs), project requirements and contractual/budgetary guidelines. May participate in feasibility and/or identification activities.
Carillon Assisted Living August 2018- Jan 2019
Supervisor/Medical Technician
Supervise and train all PCAs and Medical Technicians on administration of oral and external medications to residents under the direction of a registered nurse or a licensed practical/vocational nurse.
CESI Solutions (Non-Profit) Feb 2017-March 2018
Proposal Clerk
Quality Assurance of all Proposals and Payment distribution for creditors and over 3,000 clients in CESI debt management program to make sure they are within budget and meet completion timelines. Maintain the proposal EDC Credisoft system by inserting and retrieving confidential client information. Verification and distribution of all creditors, clients and internal company payouts.
Bioclinica, Durham, NC April 2016- October 2016
Sr. Project Manager
Strategic project leader with a proven track record of managing complex client programs from inception to delivery, ensuring high-quality execution within scope, budget, and timeline. Expert in directing cross-functional teams and mentoring project management staff to drive operational success in dynamic environments. A dedicated client advocate experienced in managing stakeholder expectations, navigating risk assessment and contingency planning, and overseeing technical onboarding and user acceptance testing (UAT). Recognized for optimizing infrastructure and internal processes to improve project delivery, while maintaining a sharp focus on business growth and client satisfaction.
The Channel Company, Raleigh, NC Feb 2015- Feb 2016
Project Manager/Quality Assurance
Managed the full project lifecycle from initial planning through deployment, overseeing budget forecasting, resource allocation, and invoice management to ensure high-quality delivery. Acted as the primary liaison between internal stakeholders—including Developers and VPs—and external clients to align system enhancements with business goals through rigorous change control, system validation, and troubleshooting. Beyond core project management, I led Quality Assurance (QA) initiatives to prevent defects throughout the SDLC and developed comprehensive multimedia training materials and animated voice-over videos to facilitate seamless onboarding and user adoption. By maintaining meticulous documentation and fostering strong vendor and client relationships, I consistently secured repeat business and optimized operational workflows.
PAREXEL, Durham, NC January 2013 – December 2013
Clinical Enrollment Manager
Managed and trained 22 clinical sites, translating complex protocol requirements into actionable daily routines and localized recruitment strategies to exceed enrollment targets. Spearhead both remote and risk-based monitoring, performing rigorous source document verification (SDV) and eCRF data cleaning to ensure 100% accuracy and compliance. Acted as a cross-functional liaison between site staff, in-house monitoring teams, and CRAs to resolve issues, facilitate patient referral processes, and maintain comprehensive enrollment databases. Additionally, developed multi-channel recruitment materials, conducted technical spirometry training, and maintained an 85% travel schedule to foster high-performing site partnerships and drive clinical project timelines.
MERGE HEALTHCARE, Morrisville, NC July 2011 – Sept 2012
Project Manager II (Sr. Project Manager)
Directed full-service clinical projects as the primary client liaison, overseeing all aspects of project management including timelines, budgets, and cross-functional deliverables. Spearheaded the requirements gathering and building of client CRFs for electronic data capture (EDC) systems, managing the database lifecycle from study startup through archive and ensuring high-quality SAS data specifications. Proactively identified project risks to implement mitigation strategies and corrective actions, while contributing to Quality Management System (QMS) development and product specifications. Additionally, supported business development through sales presentations and bid defenses, and fostered team growth by mentoring junior Project Managers and presenting comprehensive training materials at investigator meetings.
NOVELLA CLINICAL, Durham, NC January 2009 – July 2011
Global Quality Assurance Administrator
Directed the design, implementation, and maintenance of the Global Novella electronic document management system (EDMS) and INFOLINK tracking database, ensuring all controlled documents met rigorous quality lifecycles and annual update requirements. Spearheaded Quality Management System (QMS) testing and implementation in strict compliance with GCP, HIPAA, 21 CFR Part 11, and ISO 9001:2000 standards. Managed the full audit lifecycle—including coordinating with Global and Clinical Directors, facilitating regulatory agency audits, and managing CAPA tracking and reconciliation—to ensure rapid document retrieval and issue resolution. Collaborated with Validation Managers to maintain historical record books and electronic validation files, while optimizing internal processes for SOP development and archiving. Additionally, supported business operations by maintaining approved vendor lists, managing client satisfaction surveys, and providing comprehensive administrative oversight for quarterly Quality System Management Review Meetings.
Senior Project Coordinator (Novella) March 2007 – Jan 2009
Empowered upper management and project teams by coordinating the full lifecycle of awarded clinical projects, from study startup and kickoff to archival. Spearheaded the design and maintenance of critical clinical master plans, study-specific web portals, and corporate investigator databases, providing targeted analytics to directors for site selection. Managed complex operational workflows, including site payment processes for global studies with 100+ sites, regulatory document collection (IRB, 1572s), and site initiation visit (SIV) coordination. Demonstrated technical versatility by supporting system validations, performing remote site monitoring and source document verification, and managing the electronic document control system in alignment with SOPs and quality standards. Additionally, facilitated regulatory audits, mentored staff on payment processes, and implemented company-wide invoicing tools to enhance financial and operational efficiency.
PPD, INC., Morrisville, NC March 2006 – March. 2007
Associate System Designer (Project Management)
Provided management of global clinical database design timelines, budgets and significant issues with the system design for all systems assigned. Developed system tests, data loading documentation and report validation documentation.
Coordinated the efforts of IVRS Developers and support staff and serve as the primary liaison with clinical project management team and clients.
Designed user requirements and technical specifications for IVR Systems and reports, as well as help to define interaction of IVR data with other clinical databases at PPD or vendors.
Developed training materials and system support guidelines and train users and support staff as needed.
QUINTILES, INC., Morrisville, NC October 1997 – November 2005
Project Management Associate/Supervisor of Project Coordination/Project Coordinator/Site Administrator
Directed global Phase I-IV multi-service projects and led a team of Project Coordinators to ensure the high-quality delivery of clinical deliverables within budget and strict timelines. Served as the primary liaison for sponsors, investigator sites, and internal finance departments, managing everything from site recruitment and regulatory documentation (IRB, CVs, 1572s) to investigator payments and study archival. Spearheaded technical operations by executing IQ/OQ/PQ validation plans, performing data transfers using SQL/TOAD, and training call center staff on complex study protocols and inclusion/exclusion criteria. A subject matter expert in audit readiness, I conducted internal and external audits in compliance with SOP, GCP, and 21 CFR Part 11 guidelines, while utilizing CTMS and Remedy tracking tools to monitor site trends and optimize project performance.
EDUCATION
BS, Strayer University- Business/ Healthcare Management, Raleigh, NC) Oct 2017-current
BS, Health Administration, University of Phoenix, Phoenix, AR (Aug 2010-Sep 2012 transferred)
Diploma – Medical Assistant, Center for Employment Training, Durham, NC (May 1996)
Diploma- Garner Senior High School, Garner Senior High
CERTIFICATIONS
Oracle PL/SQL, DB Basics Certificate, Raleigh, NC (September 2001)
Microsoft Access Certificate, CompUSA, Raleigh, NC (April 2000)
Medical Terminology, ICD-9-CM, CPT-4 Certificate, Wake Technical Community College, Raleigh, NC (January 1999)
NC Certified Peer Support Specialist 2026
Certified Grief &Trauma Coach 2021
CPR Certified-2026
ADMINISTRATIVE
Records Management & Filing Methods, Using Computer & Business Machines, Billing & Collections, Basic Accounting, Bookkeeping & Insurance Procedures, CPT & ICD-9 Medical Coding, ICH / GCP guidelines, HIPAA, 21 CFR 11 and company specific Standard Operation Procedures (SOPs)
THERAPEUTIC AREAS
Central Nervous System (Multiple Sclerosis, Alzheimer’s, Parkinson’s, Diabetes, DVT), Oncology (Metastatic Breast Cancer, Prostate Cancer), Auto Immune (HIV, Chronic Pancreatis, etc.) Gastroenterology (Gastroesophageal Reflux Disease, Spasticity), Urology, Respiratory, ENT, Cardiology (Stents), Device Studies (Stent, Insulin pump, pacemakers, inhalers, invitro imaging etc.)
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