Summary
Overview
Work History
Education
Skills
Other Certifications Training
Computer Other Systems
Clinical Indications Experience
Timeline
SoftwareEngineer
Charla Tambourine

Charla Tambourine

Research-Clinical Operations
Wylie,TX

Summary

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.

Senior Regional Clinical Operations Manager (RCOM)

Vifor Pharma International
08.2005 - 06.2013
  • 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
  • Pulmonary/Respiratory: COPD, Pulmonary Hypertension
  • Rheumatology: Systemic Lupus Erythematosus, Myasthenia Gravis, MS
  • Renal Disease, inclusive CKD, ESRD, HD, and con-morbid conditions of the patient in renal failure
  • Osteoarthritis of the Knee-Genicular Artery Embolization (new device indication)
  • Uterine Fibroid Embolization
  • Embolic to treat hemorrhages (urgent/emergent indications)

Timeline

Manager, Clinical Operations

Merit Medical Systems, Inc.
07.2022 - 10.2023

Manager, Clinical Quality Assurance

Frenova Renal Research (a company of Fresenius Medical Care, North America)
06.2020 - 07.2022

Manager, Clinical Research Associates in Clinical Operations

Frenova Renal Research (a Company Of Fresenius Medical Care, North America)
06.2014 - 06.2020

Senior Regional Clinical Operations Manager (RCOM)

Vifor Pharma International
08.2005 - 06.2013

Senior Clinical Research Associate

Novartis Pharmaceuticals
05.2003 - 07.2005

Clinical Research Associate (CRA)

EMBOL-X Inc. / A-Med Systems Inc.
09.2001 - 01.2003

Research Coordinator/Research Nurse

Cardiopulmonary Research Science and Technology (C.R.S.T.I.)
09.1998 - 08.2001

AD - Nursing

Louisiana State University

BS - Nursing

University of Texas At Arlington

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Charla TambourineResearch-Clinical Operations