Senior nurse leader with ** years of clinical and industry experience. Excellence in strategic planning, quality management, legal and regulatory compliance. Passion for building intrapersonal relationships with patients and co-workers. Experience in delivering quality care to patients with strong knowledge of standards of care. Committed to excellence in all areas of nursing practice.

PROFESSIONAL EXPERIENCE

Irrimax Corporation

Director, Medical Operations & Compliance (October 2017-February 2020)

Developing and leading onboarding/orientation for clinical team to achieve corporate goals while maintaining compliance with applicable standards, policies, and regulations

Establishing professional relationships with physician shareholders to exchange knowledge and identify business opportunity

Collaborating with clinical regulatory, quality and legal in preparation for FDA filings

Serving as lead clinical complaints investigator and work with quality, regulatory and legal to ensure timely reporting of adverse events when necessary

Executive member of Veeva Power Team from initiation through implementation of MedComs, PromoMats, CRM and MIRF database

Serving as medical review and sign off on promotional and medical material

Serving as medical and compliance approval for all field medical meetings

Serving on CAP team by providing input on clinical considerations in defining project requirements, testing and risk management for product cap

Coaching and directing field teams to meet established business objectives and compliance

Managing two continuing education programs, including accreditation

Supervision of Manager, Medical Operations & Compliance

Irrimax Corporation

Manager, Clinical, Research & Regulatory Services (July 2014 – October 2017)

Managed 30+ members of professional referral program, including surgeons from multiple specialties, OR Directors and Infection Preventionists

Developed and managed clinical document system, including executive team review through document approval to field team

Responsible for overseeing 150+ customer questions per month, including compliance with legal and regulatory requirements, documentation, and monthly reporting

Directed, planned, and executed clinical request process to educate field team on current clinical information, assuring quality, legal and regulatory compliance rigor

Served as national clinical evaluation specialist from initiation to publication

Collaborated with Clinical VP to review, edit and author clinical SOPs

Managed all CHG and irrigation related article distribution and reprints for field nurses, sales and customers

Provides customers with value analysis clinical education

Managed purchasing of new scientific literature

Collaborated with Clinical VP, legal, regulatory and compliance on all clinical and sales tools

Educated field nurses, sales and customers on clinical safety testing and developed reference tools for field nurses

Served as Unique Device Identifier (UDI) 24-hour live nurse contact

Lead clinical complaints investigations with end-user in tandem with quality and legal to meet all FDA time-line requirements

Managed consultants for clinical tools including medical writers and biostatisticians

Responsible for Medical Device Reporting (MDR) of adverse events with legal and quality team

Collaborated with all departments to maintain quality compliance

Responsible for updating staff on all clinical policy, tools, or collateral changes

Created clinical orientation for onboarding with Director, Professional Education and Clinical Field Operations

Managed international clinical demands for Chile and Brazil

Product expert in regulatory claims, filings and statement of fact including safety testing, animal studies, bench studies, clinical trials, investigator-initiated trials, kinetic time kill studies and case reports

Managed contract nurse for clinical, research & quality department

Interviewed new clinical team members

Irrimax Corporation

Clinical Liaison (January 2011 – July 2014)

Managed Professional Referral Program

Responsible for answering all clinical customer questions and related compliance

Re-designed clinical question log for data retrieval and compliance with regulatory requirements

Responsible for tracking clinical question patterns, customer feedback, usage and ordering

Managed a Level I Trauma Center clinical evaluation in OR for colorectal patients from initiation to poster publication

Collaborated with clinical trial team to create clinical trial master file, including synopsis, instructions for use, protocol, case report forms, product labels and feasibility forms

Managed surgeon relationships with national clinical trial sites, including CDAs, feasibility questionnaires

Oversaw collection of IRB information for 10 clinical trial sites for budgeting

Managed case report and exemplar writing by developing outline criteria and gather data set from surgeons

Oversaw closure of two clinical trial sites by meeting with PIs and ensuring policies and procedures were followed for closure documentation with site, clinical trials.gov, IRBs, subject logs, case report forms, termination of monitor and final invoicing

Lead contact for planning, budgeting and publication of mice study entitled Peritoneal lavage using CHG at the end of colon surgery reduces postoperative intra-abdominal infection in mice

Malcolm Randall VA Medical Center

Surgical/Cardiothoracic Intensive Care Unit RN (May 2008 – December 2011)

Post-anesthesia recovery and patient care of surgical and cardiothoracic intensive care patients

Served on Evidence-based practice committee

Served on Nurse Practice Council in establishing unit education and guidelines

Worked with new nurse residents to orient to unit

Coordinated care with physical therapy, occupational therapy, surgical services and respiratory

Educated families on patient status and care plan

EDUCATION

Masters of Science in Nursing, May 2012 University of Florida

Bachelor of Science in Nursing, August 2009 University of Florida

Associate of Science in Nursing, May 2008 Santa Fe Community College

CERTIFICATIONS

Registered Nurse (Multistate Florida License 9280208, Expires 4/2024)

BLS Certification (Expires 1/2025)

ACLS (Expires 1/2025)

AACN Clinical Nurse Leader (CNL) (2012-2017)

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