WANDA KAY NORTH, PHD, MBA, RN, CCRC, CIM

*** ******* ***** **** · Ponte Vedra, FL 32081 · Cell # 912-***-**** · Email: ad2m6g@r.postjobfree.com

EXECUTIVE LEADERSHIP

Director, Clinical Operations · Director, Clinical Research · Project Manager, Clinical Programs

Clinical executive with consistent successes in clinical and research program start-up and/or restructuring, and program leadership. High level accountability of deliverables for inpatient and outpatient Phase I-IV multi-therapeutic pharmaceutical, medical device and physician-initiated studies from start-up to completion. Engage programs to promote a culture of integrity, accountability, transparency, quality, and top performance while always putting patient/subject safety as priority. Independent, result-driven, self-starter with strong interpersonal and collaboration skills. Strong military medical and project management background engaged in identifying, planning, developing, implementing, and managing variety of clinical projects and programs. Passionate and ethical with belief to “always do the right thing as the right thing is never the wrong thing.”

QUALIFICATION SUMMARY

Multi-therapeutic Phase I-IV Inpatient & Outpatient Research Leadership · Program Development · Clinical and Military Project Management · Quality Improvement and Compliance Oversight · Successful Subject Recruitment Management · Technology Implementation · GCP & ICH, and Federal Regulations Subject Matter Expert · Process Improvement Implementation · Grant Writing · Financial and Contract Lead · Passion for Healing Ministries

KEY PROFESSIONAL EXPERIENCE

M3/Wake/MSRA - Site Director (May 2023-October 2023)

Provide clinical operational leadership, accountable for all program deliverables for a sponsor-excellence, multi-therapeutic pharmaceutical and medical device research site, with over 500 enrolled subjects/patients.

Spear-head clinic projects to improve workflow, time efficiency, and work proficiency.

Establish performance plans for study activities and staff growth.

Manage flow of all study activities from start-up to study closeout.

Identify physician and staff training needs for compliance with GCP and FDA regulations, and company policies.

Collaborate with regulatory staff to improve processes and implement use of technology to reduce time, paper, and storage needs.

Identify and implement community opportunities and projects to increase awareness and support of clinical research with the community.

PPD/Thermo Fisher Scientific - Director, Clinical Operations Phase 1 (May 2022 – February 2023)

Increased knowledge of Phase 1 studies, participating and providing oversight of all study activities to include site feasibilities, pre-study visits, bid defenses, contract reviews, budget development, source development, training, recruitment, enrollment, close-out, and overall project management activities for a 32-bed unit.

Lead projects to streamline and improve study start-up activities to deliver FSFV within 24 business hours of site initiation.

Supervised and coordinated department functions, mentored, and provided oversight for over 60 personnel to include clinical, pharmacy, lab, recruitment, and quality.

Identified opportunities to stay abreast of local market opportunities and encouraged staff participation.

Managed multiple clinic projects and communicated with sponsors, vendors, site management, and clinical leaders to ensure strong communication and collaboration in all project and study activities.

Lead training project to address compliance need, working collaboratively with department managers; introduced cross-training for appropriate staff.

Extensively worked with Quality to review and resolve over 100 past quality events and scientific misconduct activities and to develop new process plans.

Texas Back Institute – Director of Clinical Research, Spine Biomechanics Lab & Fellowship Program (October 2020 – May 2022)

Directed the restructure and growth of a pharmaceutical, medical device and physician-initiated spine research program across 8 private practice groups with over 20 investigators.

Identified and implemented process improvement activities to ensure compliance with standard processes, policies & procedures.

Reviewed and executed study contracts and budgets; reviewed subject/patient billing records to ensure billing compliance.

Mentor to new surgeons and fellows.

Implemented a Quality Assurance (QA) component for all research conducted throughout the practice.

Restructured administrative activities of the spine fellowship program and internal operations of a spine biomechanics lab, ensuring improved compliance with research projects.

Collaborated with physicians and scientific writers in the research and publication of physician-initiated spine-related studies and manuscripts.

Baptist MD Anderson Cancer Center (MD Anderson Affiliate) - Administrative Director of Research & Tumor Registry (June 2016 – June 2019)

Directed the strategic growth and expansion of oncology clinical research at Baptist MD Anderson Cancer Center (BMDA) to implement local, US and global cutting- edge pharmaceutical, device, and physician-initiated protocols into routine care for patients.

Leader in implementing new clinical trial management system (CTMS) for both the oncology and non-oncology research departments.

Directed the project management of all study startup, initiation, enrollment, and site-closeout activities for local, US and global studies.

Streamlined time between site selection and initial enrollment to drive accelerated enrollment for patient access to potential life-saving pharmaceutical treatments.

Provided oversight for all activities related to Tumor Registry and CoC; developed and implemented training and orientation activities.

Effectively constructed timepoint measures to ensure studies were initiated on-time and enrollment completed within sponsor’s expectations.

Indian River Medical Center (Duke Medicine Affiliate) - Director, Clinical Research (August 2014 – January 2016)

Identified strategic business plan to implement projects and processes to develop a new oncology clinical research program, partnering with US based and global partners.

Performed system-wide financial audit for previous research activity; identified system gaps and non-compliance issues; collaborated with Chief Compliance Officer and Chief Legal Counsel to develop auditing process for non-system research activities.

Provided consultation to physicians and executive team for research issues; in collaboration with Duke Cancer Network, implemented continuous quality improvement activities for hospital and physician practices.

Revamped hospital policy committee and policies to achieve standardization throughout all inpatient and outpatient departments.

St. Joseph’s/Candler Health System – Manager, Research & Infusion Therapy (May 1995 – August 2014)

Lead business development strategy to develop and implement a new hospital-based, multi-therapeutic, pharmaceutical and device, inpatient and outpatient research program with over 100 continuous studies at any given timepoint; accountable for all resourcing, development, training, and leadership.

Managed the strategic oversight, growth, and guidance of all research operations, ensuring quality within 2- campus hospital and multiple private practices; implemented quality assurance program for research.

Directed study startup activities for local, US and global pharmaceutical and device studies; successful in development of processes to ensure site start-up within 4-6 weeks of site selection; responsible for oversight of all clinical, regulatory, financial, contractual, and quality site activities.

Leader and driver in identifying and implementing processes and projects for site success.

Identified and trained new investigators; provided training oversight for all research staff team.

Assisted with the development, review, revision, and approval for all ICF’s, assistance with manuscript of several physician-initiated protocols, and development of all marketing materials.

Served as research subject expert and advocate for a 650-bed, two campus health system.

Selected above peers to develop, implement, and oversee a new outpatient infusion center in conjunction with responsibilities as research manager; successful in the quick clinic growth and profitable revenue in less than 6 months.

United States Air Force Reserve – Retired as a Lieutenant Colonel (October 1987 – June 2015)

Positions:

-IMA Assistant to Chief Nurse, Triage Nurse, Disease Management Nurse, Patient Safety Manager, Clinic Supervisor, Chief of Military Equal Opportunity, Executive Officer – “XO”, Flight Nurse with Additional Duties of Officer-in-Charge (OIC) Scheduling, OIC Special Projects, Health & Wellness Officer, and OIC Squadron Historian

Initially trained as Flight Nurse, participating in over 3000 hours of flight time in aero-vac missions, both in peace and wartime; directed in-flight patient care services and aircraft emergencies.

Assisted with training and supervisory oversight and tracking of training activities for over 200 active duty, reserve, and civilian medical personnel.

Selected as Chief of Military Equal Opportunity Program for the 315th CAFB Reserve Command; primary point of contact and liaison between the Equal Employment Opportunity (EEO) Offices and all Reserve Commanders.

Identified as successful project leader to develop, implement and oversee multiple military projects and programs.

Participated in planning, developing, implementing, and evaluating population health program to ensure Healthcare Effectiveness Data and Information Set (HEDIS) compliance and initiatives were in collaboration with providers, Government Program Manager (GPM), Health and Wellness Center, TRICARE Service Center and community agencies.

Selected to serve as liaison for reserve unit commander and active-duty chief nurse; assisted with implementing, tracking and completion of projects within an active-duty outpatient clinic and reserve aero-vac unit.

Other Career Roles

PRN Home Health Nurse (HCA/Brookdale Home Health (October 2019 – Present)

Interim Manager, Oncology Clinical Research (Cancer Specialists of North Florida) (February 2016 – May 2019)

Adjunct Assistant Professor in Clinical Research and Leadership (George Washington University) (May 2011 – June 2012)

Territory Representative - DuPont Pharmaceuticals (May 1990 – March 1995)

Neonatal ICU RN (Medical University of SC) (August 1988 – April 1990)

Neonatal ICU RN (Jacksonville University Hospital) (December 1987 – August 1988)

Stroke Rehabilitation RN (Memorial Medical Center) (October 1986 – December 1987)

EDUCATION

PhD Health Administration - Warren National University

Master of Business Administration - Webster University

Bachelor of Science in Nursing - Medical University of South Carolina

Associate of Science in Nursing - Florida Junior College

Associate of Arts - Florida Junior College

PRESENTATIONS, AWARDS AND VOLUNTEER ACTIVITIES

Recipient of multiple awards within military and civilian career; recipient of the prestigious Lientz Award at St. Joseph’s/Candler Health System.

Presenter within ACRP, National Association of IRB Managers, hospitals, and community events.

Participate in numerous community activities; serve in leadership roles within volunteer committees and programs.

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