Talented Manager with expert team leadership, planning and organizational skills built during successful career. Smoothly equip employees to independently handle daily functions and meet customer needs. Diligent trainer and mentor with exceptional management abilities and results-driven approach.
Overview
25
25
years of professional experience
Work History
Manager, Clinical Operations
Merit Medical Systems, Inc.
07.2022 - 10.2023
Responsible for implementation and management of the execution and operations of multiple studies of medical devices
Assist in generation supporting study documents such as Protocol development and CRFs, Informed Consents, Investigator Brochures, SAE and death reports
Achieved departmental goals by developing and executing strategic plans and performance metrics
Assist with submissions including annual IDE updates to the FDA
Progress summaries for data safety monitoring board/committees (DSMB) and/or CEC
Create investigational plans (CMP, PMP, IP, etc.) and infrastructure for conducting studies
Manage department clinical trial operations daily, driving deliverables
Ensure accomplishment of key clinical milestones, including study enrollment
Assist in identifying, qualifying, and initiating clinical sites
Ensure quality of data collection, including conducting quality assurance of data monitoring
Share in budget preparation for clinical studies (VP of Merit oversaw all budgets)
Devise and assist clinical trial sites with developing and implementing enrollment strategies
Identify and assist sites in overcoming performance hurdles
Oversee project management performance, including timely execution of site and project managers agreements and IRB approval
Assist in hiring departmental personnel
Train new clinical trial assistants and project managers and assist in training of clinical trial monitors
Manage contract employees such part-time monitors and vendors for clinical trial services
Increased team productivity by implementing streamlined processes and effective communication strategies
Manager, Clinical Quality Assurance
Frenova Renal Research (a company of Fresenius Medical Care, North America)
06.2020 - 07.2022
Developed, revised, and implemented company Clinical Trial Standard Operating Procedures (SOPs)
This included expiration and tracking of future needed updates
Ensured all processes that contributed to clinical trial performance were conducted appropriately
Provided guidance and oversight for all related internal and external auditing activities
Evaluated audit and inspection visits
Acted as subject matter expert in the complex areas of ICH/GCP, industry guidelines, federal and local regulations, and company policies
Maintained and communicated knowledge of changes in the fields of clinical trial guidelines, regulations, and policies
Implemented in-depth quality improvement programs and training
Recognized and identified potential areas where existing policies and procedures require change or where new ones need to be developed
Appraised vendor qualification and conduct on site vendor qualification audits as required
Provided leadership role in the evaluation of and response to high-level queries and quality events
Identified and communicated high-level compliance issues to senior management
Tracked and reported monthly progress regarding closure of outstanding audit findings
Researched, proposed and deployed QA tools required to meet QA needs
Ensured appropriate training for Frenova personnel and documentation of training as required, including support of on-boarding new SMO sites
Hosted audits conducted by external clients and provided full response to findings
Planned the resource needs including ongoing organization structure around QA and Requirements Management process
Recruited, mentored and directed employees and consultants required to meet the fluctuating QA needs
Reviewed and complied with the Code of Business Conduct and all applicable company policies and procedures, local, state and federal laws and regulations.
Manager, Clinical Research Associates in Clinical Operations
Frenova Renal Research (a Company Of Fresenius Medical Care, North America)
06.2014 - 06.2020
Managed CRA team of 12 as required by project
Supervised CRAs to ensure they met expectations of core monitoring responsibilities
Oversaw conduct of studies at FRR sites to ensure timely enrollment and Principal Investigator compliance
Ensured study team was appropriately trained for their assigned studies
Performed site audits in conjunction with Quality Assurance department
Ensured monitoring quality, ICH GCP, and consistency of monitoring standards at site level through accompanied visits (AV) with CRO, consultants or internal staff
Ensured data quality at site level
Coordinated the activities of clinical monitoring team / department with direct responsibility for results, including costs, methods, and staffing
Ensured adherence to SOPs for clinical operational activities as required
Provided leadership, coaching and development plans for all direct reports to maintain an engaged and productive workforce
Managed CRO clinical operations including but not limited to, oversight of monitoring tasks, monitoring visit report review and approvals, and identification of training requirements
Identified and created strategy for patient recruitment and retention in conjunction with the CMP
Interacted frequently with staff, managers, internal departments and external clients/managers normally involving matters between functional areas, other company divisions, or customers
Interacted frequently with internal departments and external clients/managers focus on problem solving
Responsible for hiring, initial and continued training, coaching and counseling employees
Performance reviews, disciplinary actions and terminations
Managed turnover and retention of CRA’s to meet company objectives
Performed annual review/performance reviews
Reviewed study plans, reports and study specific guidelines
Worked with Clinical Project Managers and other team members on the creation, review and execution Clinical Monitoring Plans, Monitoring Activities, Clinical Study Plans, Investigation Product Plans, Safety Plans, and study specific instructions.
Prepared and executed presentations of project specific and therapeutic training to clinical project team members
Orchestrated internal and external project team meetings/teleconferences
Inclusive of clinical, data management, all vendors, senior leadership teams
Reduced turnaround time for project completion through effective resource allocation and team management
Ensured project team completion of procedural documents, review of data listings, and final reports
Developed feasibility questionnaires for site selection
Responsible for final decision re site selection for the phase III HD & PD studies
Developed project monitoring plans, CRFs, review/input into protocol development
Managed/Trained/Supervised the CRA team both internally and for CRO partners, included the tracking of metrics and site visit report review
Developed study project tools/documents, tracking and monitoring forms
Created/implemented patient recruitment and retention strategies
Developed/implemented training for the clinical project team in the therapeutic area and disease process
Interviewed new personnel as required, mainly CRAs
Evaluated and identified resourcing needs and continuously monitored over life cycle of project
Worked with project team re problem solving with solutions
Reviewed and approved trip reports, expense reports, and work-timesheets
Worked with finance regarding invoices, approval and tracking of Investigator and site payments according to contract/budgets
Identified and initiated CAPA per SOPs as needed through resolution of issues
Worked with QA regarding audit plans through resolution
Identified, addressed, and escalated site issues and drove to closure
Early recognition of areas with potential problems and provided input to contingency plans
Accompanied visits made with CRAs
Monitored sites when CRAs unavailable or project under-resourced re CRA coverage
Performed periodic quality TMF checks to ensure files were up to date and vendors were fulfilling contractual obligations
Made master file inspection ready
Drug Safety - developed SAE forms used in the USA and the pregnant partner forms, ICF development, etc
EDC Training/electronic case report forms
Remote monitoring/developed charter
Attended (sponsor support) 3 site FDA inspections
Assisted PI & Staff with responses to FDA audit findings
Maintained professional development through participation in professional meetings and career development programs.
Senior Clinical Research Associate
Novartis Pharmaceuticals
05.2003 - 07.2005
Trained sites new Clinical Research Coordinators on the background of Clinical Research, FDA regulations and GCP guidelines, Coordinator responsibilities, screening and enrollment strategies, proper Informed Consent execution, and the Rights and Protection of Human Subjects, HIPAA
Reviewed Clinical Trial Protocol with Study Personnel
Identified issues with sites and implemented ways to improve protocol compliance
Improved clinical trial efficiency by streamlining data collection and management processes
Enhanced patient safety through meticulous monitoring of adverse events and protocol compliance
Provided thorough instruction on proper electronic Case Report Form completion
(eCRF) for site staff and for new CRA’s
Monitored assigned sites (PSV, SIV, IMV, COV)
Generated and closed data queries
Reach DBL on time and on budget
Perform drug accountability
Assisted site personnel and data management with data query resolution
Assisted sites in maintaining an up-to-date regulatory binder/investigator site file
Provided ongoing feedback to sites regarding progress and compliance
Assured sites were compliant with their individual IRB/Central IRB reporting requirements
Generated detailed clinical monitoring reports and follow-up letters per CMP.
Clinical Research Associate (CRA)
EMBOL-X Inc. / A-Med Systems Inc.
09.2001 - 01.2003
Recruited, screened and recommended clinical investigators
Improved patient enrollment by developing and implementing effective recruitment strategies
Assisted with development of CRFs and study material
Assisted with development of monitoring tools
Performed pre-site selection, initiation, interim monitoring and close-out visits
Conducted clinical trials site management (enrollment tracking, regulatory review and tracking, site payments, etc.)
Performed device accountability
Enhanced data quality by closely monitoring study progress and ensuring accurate data collection.
Performed electronic data capture CRF completion and query resolution
Mentored new CRAs, Co-monitored with other CRAs employed by a Contract Research Organization
Followed FDA regulations and GCP guidelines for Phase II and III trials
Served as proctor in order to train Investigators in the Operating Room on proper device usage
Generated detailed clinical monitoring reports and follow-up letters promptly/per MP
Assisted in the development and maintenance of database used for tracking compliance issues
Audited critical document files
Prepared and completed FDA panel prep assignments for the Embol-X intra-aortic filter IDE
(FDA – October 23, 2002)
Including literary summary development used for the 510(k) filing.
Research Coordinator/Research Nurse
Cardiopulmonary Research Science and Technology (C.R.S.T.I.)
09.1998 - 08.2001
Screened subjects, Enrolled subjects in studies
Completed ICF process and documented the process
Implemented protocols, follow-up regimes for each study
Collected and submitted data from various cardiopulmonary research projects
Submitted and maintained regulatory documents
Interacted with various hospitals Investigational Review Board’s (IRB’s) and review committee’s
Reported SAE/adverse events to the sponsor, & IRB
Performed chart audits – medical records
Responsible for test article accountability
Documented laboratory procedures
Case report form completion and maintained source documents
Query resolution.
Education
AD - Nursing
Louisiana State University
BS - Nursing
University of Texas At Arlington
Skills
Contract Management
Operations Management
Team Leadership
Verbal and Written Communication
Quality Assurance
Staff Training and Development
Policy Implementation
Staff Development
Strategic Planning
Performance Management
Performance Evaluations
Time Management
Other Certifications Training
Texas State Registered Nursing License. #566415, Status; Current (To verify license status- https://www.bon.texas.gov)
Collaborative Institutional Training Initiative (CITI Program_ICH GCP with FDA focus)
Good Clinical Practice
ACRP CCRA
Computer Other Systems
EMedical Records
Fountayn EDC (formerly DataTrak)
Medrio EDC
Oracle
PhaseForward
EDETEK
Endpoint
ECOS
H2oClinical
Inform
Rave EDC
IMetadata
IBM EDC
Clinical Conductor Enterprise (CCE, a CTMS)
Power Point
Florence eBinders-eTMF
Smartsheet
Microsoft Office 365
Microsoft Teams
Excel
PolicyTech
SharePoint
Clinical Indications Experience
Cardiovascular: Heart Disease, Pulmonary Hypertension, Open heart surgeries on and off pump, Mid-CAB, Heart Valve replacement, Arial fib/flutter, Coronary Artery Disease (CAD)
Device: Cardiac Stent, ZEUS robotic surgical studies, Heart Valves, EMBOL-X filter for open-heart bypass and valve replacements, Transluminal Revascularization (TMR), St Jude Medical Anastomotic device
Neurology: Neurocognitive study post CABG, OpCAB studies
Nephrology: End Stage Renal Disease, Hyperphosphatemia, Anemia in Hemodialysis and Peritoneal Dialysis, Lupus Nephritis