Clinical Research Quality Assurance

Joan Wilson, MSN, MHA, RN

Evans, GA. ***** c 706-***-**** ***********@*****.*** LinkedIn: https://www.linkedin.com/in/joan-wilson-msn-mha-rn-7984aa10/

PROFESSIONAL SUMMARY

Dedicated and resourceful Director of Clinical Research with 15+ years of experience in spearheading clinical research initiatives, leading high-performance teams, and implementing innovative strategies to maximize operational excellence. Highly proficient in overseeing comprehensive clinical trials, establishing standard operating procedures, and deploying quality assurance measures to drive revenue growth. Adept at fostering strong vendor & stakeholder partnerships, developing risk management solutions, overseeing staff training & development measures, and advancing clinical research programs to achieve organizational goals.

EMPLOYMENT

Joseph M. Still Research Foundation, Inc. Feb 2017 – Present

Director of Clinical Research

Reorganized the entire department, established SOPs, implemented a research review process for project implementation, and initiated the regulatory process and protocol for all projects moving forward

Function in a matrix-driven, proactive environment to ensure compliance with department objectives and quality outcome measures

Lead and oversee the implementation and execution of clinical trials

Participate in strategic planning efforts for the department

Project management and oversight of all projects, including study protocols, clinical trial budgets, contracts, CRF creation, database management, maintaining project timelines, ensuring meeting enrollment goals, and implementing risk strategies

Cross-functional collaboration with internal and external stakeholders on clinical trial objectives, milestones, internal processes, and quality assurance measures.

Provide operational expertise and strategic input into the development of department and clinical trial plans and support the overall strategy of the research program

Serve as point of contact for all vendors, CROs, sponsors, and other external stakeholders, overseeing their roles and input to ensure compliance with department SOPs and ICH-GCP guidelines

Oversight of departmental compliance with regulatory requirements, ICH-GCP requirements, and foundation SOPs throughout all stages of clinical trial conduct.

Author and maintain the foundation SOP handbook, all updates, and version control

Develop, initiate, and manage investigator-initiated trials to ensure overall compliance

Serve as Project Lead/CRA for the site and CRO for all Investigator-Initiated Trials, including, but not limited to, the oversight of NDAs and INDs, if applicable

Author and submit all Compassionate Use Case requests to the FDA and Sponsors as necessary (includes drugs, devices, and biologics)

Point of contact for FDA, ensure inspection readiness for the site

Lead site in any audit – agency, sponsor, internal, or other

Work with internal stakeholders to develop and execute operational risk management strategies

Oversight of TMF and other regulatory documents

Educate & train immediate and extended study team members by defining learning objectives, devising training materials, conducting educational seminars & training sessions, monitoring progress, and delivering feedback

Enhancing professional development

Revitalizing operational processes by conducting thorough analyses, identifying areas of improvement, and implanting robust quality assurance measures

Increased revenue by 30%

Crawford Healthcare

Director of Clinical Resources June 2014 – Feb 2017

Oversight of all clinical research activities in the US and Puerto Rico

Support professional development by training all sales representatives on burn and wound pathophysiology and healing

Support KOL development as clinical science liaison to clinicians

Plan, initiate, and participate in educational programs, dinners, webinars, seminars, advisory boards, expert clinician panels, etc.

Cross-functional collaboration with lead scientists to establish clinical development strategies for protocols and other projects

Initiate and oversee all research conducted in the US and Puerto Rico

Served as CRA in implementing feasibility studies, selecting sites, site initiation, study start-up, study management, and study close out. Work closely with data management to clear site queries to achieve database lock, maintain study timelines, and support sites with training and education

TEI Biosciences

Director, Clinical Support June 2013 – June 2014

Oversight of all clinical research activities in the US and Puerto Rico

Support professional development by training all sales representatives on burn and wound pathophysiology and healing

Support KOL development as clinical science liaison to clinicians

Plan, initiate, and participate in educational programs, dinners, webinars, seminars, advisory boards, expert clinician panels, etc.

Cross-functional collaboration with lead scientists to establish clinical development strategies for protocols and other projects

Initiate and oversee all research conducted in the US and Puerto Rico

Served as CRA in implementing feasibility studies, select sites, site initiation, study start-up, study management, and study close out. Work closely with data management to clear site queries to achieve database lock, maintain study timelines, and support sites with training and education

EDUCATION

University of Phoenix

Online

· Master of Healthcare Administration, Master of Science in Nursing

GPA – 3.88

Augusta State University (formerly Medical College of Georgia)

Augusta, GA.

· Bachelor of Science in Nursing

SKILL HIGHLIGHTS

Leadership

Built and nurtured a successful and productive team to sustain productivity and maintain operational metrics, driving a culture of innovation and continuous improvement

Innovation

Proven ability to renew and transform failing study and team efforts by re-establishing new processes to ensure compliance and sustainability.

Communication

Successfully managed multiple sites and physician groups to achieve research goals and collaborated with external stakeholders to produce medical literature for publication from on-site work. Collaborated with various facilities and hospital groups to ensure facility compliance and regulations were followed. Facilitated study budgets, contracts, Master Facility Agreements, and Data Use Agreements among several facilities.

Microsoft Office

Expert in Project Management

Excel, Word, PowerPoint

EDC, TMF,ISF, eCRF

GCP/ICH

CRA/CRO

Detail-oriented

Proactive, critical thinker

Public Speaking

Advanced Leadership, national and global collaboration

Negotiation skills

Executive team member, leader, decision maker

Vendor management

Enthusiastic to work, eager to learn new skills

Medical writing

Established relationships with burn and wound KOLs

Contact this candidate