Quality Assurance Clinical Research

JULIE E. JOHNSON, RN, CCRC

**** ***** ***** ***** ********, GA 30068

678-***-**** *********.****@*****.***

CLINICAL RESEARCH NURSE

Resourceful professional with extensive experience in guiding clinical research studies; track record for conducting

phase II-IV investigative new product and device trials from initial pre-study start-up, submission of regulatory/sponsor

required documents, institutional review board document submission, and hosting site feasibility/qualification and

start-up meetings. Proven ability to optimize research project operations by cultivating nurturing, productive

environments for investigators/coordinators to work professionally, ensuring safety of study participants, confirming

regulatory requirements are understood as well as the impact of the requirements. Well versed in designing and

implementing quality assurance programs, internal monitoring of study data collection/management, promote

communication, collaboration and assessment of the operations of the site to produce quality data and excellence in

patient care, ensuring compliance with government regulations and industry-accepted best practices. Highly proficient

in orchestrating compelling business planning and development efforts; excelling at staff recruitment, hiring, and

training; creation of marketing initiatives; and revenue generation. Sustained excellence in liaising with critical

stakeholder groups, such as IRB members, principal investigators, research staff, and physicians.

Clinical Research Nursing Quality Assurance/ Internal Monitoring GCP/ICH Guidelines-FDA Regulatory Compliance

Project Management Standard Operating Procedures Strategic Planning Business Development Needs

Assessment Start-ups/Turnarounds Process Improvement Investigator-initiated Trials Workforce Planning

Presentations Training/Development Protocol Development Contract Negotiations Budgeting Team

Leadership/Motivation Relationship Management Vendor Relations Business Planning Reporting/Documentation

Marketing Initiatives Patient Questionnaires Employee Engagement IRBs Vendor Relations Strategic Sourcing

Data Collection/Entry/Management

PROFESSIONAL EXPERIENCE

ATLANTA GASTROENTEROLOGY ASSOCIATES Marietta, GA April/2006- January/2014

Research center focused on conducting clinical drug and device trials to test safety/efficacy of new treatment or

prevention of digestive diseases.

Lead Clinical Research Nurse/Clinical Site Development

Charged with guiding range of operations for multiple clinical trials at numerous locations, including project planning,

quality assurance, goal achievement, and ensuring patient recruitment and compliance with established protocols.

Trained and assisted research staff with protocol specific procedures, disease physiology, safety and wellbeing of

subjects, utilizing GCP/ICH guidelines, AGA SOP’s and FDA regulations, performing task related - time sensitive sponsor

driven data management. Perform all regulatory operations for research studies, related to sponsors, IRBs, and CROs;

negotiate contracts critical to clinical trials. Liaison effectively with primary investigators, sub-investigators, research

staff, and administrative personnel wherever participants interviewed/treated. Contribute to staff hiring and training,

as well as quality assurance activities to ensure compliance with ICI/GCP guidelines, FDA regulations, study protocol

criteria, and company’s standard operating procedures (SOPs).

Accomplishments:

Spearheaded Site’s (specific pod of medical offices) first-ever diagnostic device trial for colorectal cancer (CRC)

screening study having prevention as objective, interviewing coordinators and creating full protocol plan. Ensured

availability of sufficient subjects. Trained physicians to identify appropriate subjects for trial with 3-month

continuous report generated to identify prospective candidates. Medical records reviewed and assessed eligibility

of inclusion/exclusion criteria. Site recognized as “top-enroller” in U.S. and Germany with 860+ subjects enrolled,

and for excellent quality in processed laboratory specimens.

JULIE E. JOHNSON, RN, CCRC

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Atlanta Gastroenterology Associates Continued…

Orchestrated enrollment of 30 patients to participate in investigator’s collaboration with sponsor in conducting

specific laboratory test on esophageal tissue, pathology compared to FDA-approved device for uterine cancer early

detection, goal to determine the effectiveness and accuracy of detecting Esophageal cancer in subject’s with

Barrett’s Esophagus. Mastered specific laboratory processing of tissue specimens, proficient with imaging and

collection of data with software, as device was used per protocol.

Recruited to manage physician’s research program from start-up to full operation, facilitating development,

conducted first trial met sponsor’s timelines, ensured site’s compliance with industry standards, and expanded

business to generate sufficient revenues. Developed site and study plan, as well as concise filing system for

compliance documentation purposes to track various activities/requirements, such as IRB, specimen storage,

adverse events, and study drug accountability. Ordered all required equipment, facilitating proper calibration,

along with documentation and established SOPs. Study successfully conducted with principal investigator’s history

of long standing in research industry leveraged to attract additional studies within few months of initial study. Re-

opened research program generated 80% revenue increase in second year.

Negotiated between 15% to 30% increase from sponsor’s initial budget for studies overall. Determined feasibility of

study by analyzing protocol to determine its suitability for company’s involvement and potential for sponsor

choosing site again in future.

SOUTHEAST RESEARCH ASSOCIATES (SERA), DIVISION OF GEORGIA LUNG ASSOCIATES Austell, GA

October/1995- April/2002

SERA, now, Georgia Clinical Research, serves as research division for Georgia Lung Associates enabling patients to participate

in clinical research trials with access to medications unavailable to general public. Trials focus on areas such as COPD,

insomnia, sleep apnea, asthma, allergic rhinitis, chronic bronchitis, and weight loss.

Project Manager – Clinical Operations September/2000- April/2002

Responsible and accountable for guiding operations for primary research site and seven satellite sites, supervising 15-

20 direct reports. Created/delivered annual strategic operations and business plan, and ensured proper staffing,

business development, and achievement of sponsors’ goals and requirements. Led planning and implementation

efforts for each clinical study, including evaluation/communication of research team’s objectives and facilitating plan

creation. Interfaced with coordinators after study-related documents were created, organization of Sponsor’s tracking

logs and drug compliance as well as setup of subject visits. Ensure understanding utilizing techniques of training with

lead CRC training staff at site on protocol and required communication to patients and family, roles, possible areas of

concern. Supervised/assessed clinical operations, liaised with study Sponsors/CROs, and investigative site’s monitors to

ensure high quality communications and data collection/management.

Accomplishments:

Played critical hands-on role in supporting coordinators for all new trials at primary center and seven satellites sites

in developing study plans sensitive to time and labor constraints, while meeting or exceeding sponsors’ enrollment

expectations. Assessed progress for each study, redirecting efforts to address particularly difficult qualification of

patient populations.

Contributed significantly to successful completion of extremely important trial at women’s health site related to

vaccination development for human papillomavirus (HPV).

Quality Assurance Nurse Liaison March/1999-September/2000

Functioned as expert research nurse facilitating completion of single or multi-site trials, providing direction with

auditing and monitoring operations. Collaborated with multidisciplinary researchers to ensure research data

collection that integrated advances in clinical trials.

JULIE E. JOHNSON, RN, CCRC

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SERA – Quality Assurance Nurse Liaison Continued…

Led efforts to develop source documentation template for specific protocols, and communicated regularly with

sponsors to ensure on-target, timely study operations. Designed/performed patient and family education, conducted

ongoing training of clinical staff. Clinical/regulations oversight of multi-site trials, ensuring full compliance with study

protocols and proper staff training and staffing. Played active role in improving/advancing clinical research excellence

within organization.

Accomplishments:

Greatly enhanced staff professionalism, confidence, and cohesiveness at each medical specialty site, improving

productivity and revenue generation. Trained staff in leadership qualities and positive management approaches to

effectively support research staff at each site having “lead” coordinator.

Facilitated development of annual employee training that included company’s SOPs, FDA regulations, and ICH-GCP

guidelines and roundtable approach, enhancing relationship building among participants.

Promoted to Quality Assurance Nurse Liaison to ensure high quality performance of each site, while fostering more

collegial, unified staff culture; avoided potentially divisive, adversarial environment by creating professional, trusting

relationships with focus on generating optimal study data collection and documentation.

Enhanced quality of each trial, while more quickly recognizing problems/issues by monitoring 15% of each trail by

number of subjects enrolled for every study conducted, including satellite sites. Evaluated informed consent processes

and accompanying documentation. Efforts promoted continuous improvement of trial operations, ensuring optimal

compliance with all required standards and regulations.

Assistant Site Manager August/1997-March/1999

Mastered familiarity with all aspects of all protocols, including study proceedings/timelines and inclusion/exclusion criteria,

as well as, confidentiality and privacy protections. Worked closely with PIs and research staff at all satellite sites, provide

training and tools to team members and develop/implement recruitment strategies in accordance with IRB requirements and

approvals. Ensured collected of required documentation for submission to sponsors and address questions related to

protocols. Collected and reported up-to-date information of all screened and prospective subjects based on protocol

guidelines, ensured the coordinating of tests, procedures, and data collection was correct. Maintained and monitored study

files, including consent forms, source documentation, narrati ve notes, case report forms, investigational materials,

accountability forms, and Regulatory/ Investigator binders. Pursued Sponsor/CRO relationships by consistent communication

and staying abreast of client satisfaction. Monitored and ensured study milestones including subject enrollment, financials,

regulatory compliance, patient care, and SOPs. Actively supported and communicated with medical practice physicians to

increase data accuracy through assessment of documented medical histories, all medication usage, and patient call

documentation.

Accomplishments:

Led effort to develop targeted employee training program with focus on preparing talented, experienced coordinators

for assignment to new physician sites. Coordinators provided critical training and technical support to physicians and to

PIs. Training for coordinators included SOPs and required changes, ICH GCP guidelines and FDA regulations, and disease

processes; physicians having specific subject matter expertise invited to speak at trainings.

Shepherded completion of numerous studies with team approach, including esophageal reflux /heartburn trial induced

by chili meal that included 65+ patients over 2-day period, as well as, study of patient’s with COPD, enrolling 100 subjects

within 2 days.

Clinical Research Nurse October/1995-April/1997

Demonstrated knowledge of conducting all aspects of awarded protocol, including study proceedings and timelines,

inclusion/exclusion criteria, and confidentiality protections. Ensured informed consent process was conducted per ICH/GCP

and IRB regulations. Enrolled, randomized, and conducted all study specific procedures. Maintained study files, adhering

strictly to sponsor, IRB and SERA’s requirements. Planned, coordinated, and conducted all aspects of visit procedures of

assigned clinical trials.

JULIE E. JOHNSON, RN, CCRC

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SERA – Clinical Research Nurse Continued…

Accomplishments:

Enrolled 85 patients on first research trial as primary coordinator for a phase III chronic bronchitis study, as well as,

30+ patients on a phase II allergic asthma study; investigational product for the phase II trial involved

administration of IP intravenously, every two week.

Xolair, FDA-approved February, 2007

Chosen for placement in physicians’ offices new to research to mentor and train new primary investigator, medical

staff to research, and to conduct trials within their specialties including, endocrine and cardiac research.

Recognized for outstanding performance through promotion to Assistant Site Manager.

Career Note: Additional positions included Allergy and Asthma Staff Nurse with PEDIATRIC ASSOCIATES and GEORGIA

LUNG ASSOCIATES, Sub-Acute Unit Staff Charge Nurse with MCKENDREE VILLAGE, Hemo-dialysis Staff Nurse with

DIALYSIS CENTER INCORPORATED, and Acute Care Cardiac Staff Nurse with METHODIST MEDICAL CENTER.

EDUCATION/LICENSURE

Nursing, St. Mary’s Medical Center and School of Nursing

University of Tennessee, Knoxville, TN

Nursing, Middle Tennessee State University

Murfreesboro, TN

Nursing, Georgia Southern University,

Statesboro, GA

Licensed Registered Nurse, State of Georgia (Current)

Licensed Registered Nurse, State of Tennessee (Not Active)

CERTIFICATION

Certified Clinical Research Coordinator

Certified Cardiopulmonary Resuscitation

Certified Saf-T-Pak Training, Per 49 CFR 172.700/IATA,GCP/ICH Guidelines and FDA Regulations

PIC-line Certification

COMPUTER SKILLS/MULTIPLE DATA ENTRY SYSTEMS

Microsoft Office Suite (Word, Excel, PowerPoint, and Publisher) Oracle Clinical Remote Data Capture

Inform Integrated Trail Management 4.5, 4.6, 5.0 DataLabs Express Trial Manager Secure

Spectroscopy Assessment Software MIRA, Medical Imaging ECG Transmittal

Express Data System Phoenix Data System ICOPhone and ICOPhone ePRO Invivosystem

Electronic Medical Records/ Simplify MD

PUBLICATIONS/PRESENTATIONS

Master Trainer, “Train-the-Trainer,” Model Awarded by NCA

Yearly Research Staff Training Program, SERA

New SOP Development, AGA

PROFESSIONAL AFFILIATIONS

Association of Clinical Research Professionals (ACRP)

National Professional Women’s Association

Secretary, Local Chapter of ACRP

Tennessee Nursing Association

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