Clinical Research Team Member

MITTIE MITCHELL, R.N., B.S.N.

Devoted clinical team member with 20+ years of experience in pharmaceutical and device Phase I-IV clinical research. Extensive therapeutic experience in: Multiple Sclerosis, Alzheimer’s, Oncology, Psychiatry, Critical Care, Neurology, Cardiology, Endocrinology, and wound care. Committed to performing the hard work that it takes to produce quality research data to advance patient healthcare and quality of life.

WORK EXPERIENCE:

10/2022 – 2/2025 Atlanta Neuroscience Institute INC. (Formerly: Multiple Sclerosis Center of Atlanta) – Director of Clinical Research

Executing budgets and contracts. Managing Quality Assurance, Regulatory, mentoring staff, and patient care.

Preparing the team to take the CCRC exam this spring.

Also continued the coordinator role tasks listed below.

4/2022 – 10/2022 Multiple Sclerosis Center of Atlanta) – Senior Clinical Research Coordinator

Executing clinical research trials by protocol, ICH-GCP guidelines, and sites SOPs.

Development of study specific source documents.

Training of the research team and other departments about the protocol requirements.

Liaison for communication between the Sponsor, CRO, study team, and PI.

Recruitment of subjects and monitoring of their progress.

Performing EKGs, Administering / Dispensing Medications, phlebotomy, and shipping of central labs per IATA.

Monitoring for adverse events and reporting SAEs as indicated.

Assessments for MS including: 9HPT, LCVA, 500 m walk, T25FWT, SDMT, Visual Acuity by Snellen chart, MOCA, balancing testing on the Biodex machine. Assessing for sxs of flare ups.

Performing cognitive testing for patients with Alzheimer’s.

8/2014 – 4/2022 Cancer Treatment Centers of America – Research Nurse

Executing clinical research trials by protocol, ICH-GCP guidelines, and hospital SOPs

•Ensuring the integrity of clinical data and adhering to applicable regulatory, protocol, and company guidelines.

•Communicating medical concerns of clinical trial subjects to the principal investigator, sub-investigators, and all clinical team members.

•Educating physicians, clinical teams, infusion staff, and other departments regarding protocols and their study role responsibilities. Educating patients and caregivers regarding study products and processes.

•Developing study training manuals, tracking forms, site study tools for Infusion Team and Clinical teams for executing studies

•Instructing and mentoring new research staff in all aspects of clinical research. Reviewing protocols and making source documents to correlate with the study EDC for interdepartmental use.

•Developing and implementing approaches for subject recruitment. •Coordinating timely re-supply shipment of clinical supplies and study drug to facility via IVRS systems

•Maintaining adequate recruitment tracking records. •Reporting of SAEs and follow up.

•Meeting with monitors and data team to resolve queries.

•Developing and implementing corrective actions when appropriate. •Inputting and maintaining study information concerning subject status of financial reimbursement to Research Manager and Accounting office.

•Collaborating with Research Medical Director, Clinical Research Manager, and clinical care teams to resolve issues

•Participating in meetings for team coordination Performing QA on consents, source documents, monitoring reports, and execution of study procedures.

•Managing and coordinating clinical functions for clinical trials, including: Consenting, conducting study visits, performing case management, completing

EDCs, Processing lab-work, and reporting SAEs for all clinical trial patients

.

MITTIE MITCHELL, R.N., B.S.N.

2008 - 2014

Gentiva Home Health – Case Manager

Responsible for developing and updating health care plan for clients and

executing treatments as an interdisciplinary team as prescribed by physicians,

according to the plan of treatment. Performing physical assessments of clients.

Interprets assessments to clients, physicians, and caregivers. Conferring with

physicians to develop plan of treatment based on patient assessments. Providing

training for clients, families, and caregivers in reference to disease processes,

medical procedures, medications, diets, and clean and sterile technique using

universal precautions. Educating and supervising staff involved in the client’s

care. Planning and organizing schedule for my team and case load. Training new

staff.

2006 – 2008

Community Home Health – Case Manager

Responsible for assessing clients and formulating care plan with physicians.

Providing education to clients and their caregivers. Implementing medical

procedures involving: Central lines, PEG tubes, foley catheters, suprapubic

catheters, phlebotomy, wound vac dressings, wound care, etc. Mentoring,

educating and supervising team staff.

2004 - 2006

Anchor Hospital – Nurse Manager

Responsible for coordinating the care of 94 psychiatric patients. Mentoring,

supervising and educating the nursing staff. Performing infection control

surveillance and doing I.C. education for all staff and patients. Training staff in

PMAB (Preventative Management of Aggressive Behavior) and CPR. Chairing

the Performance Improvement Team. Revising all forms to meet JCAHO and

Medicare regulations. Performing quality assurance audits for nursing. Leading

groups and conducting medication education. Performing EKGs and phlebotomy.

2003 - 2004

Anchor Hospital – PRN – Weekend Staff Nurse

Responsible for coordinating the care of 50-75 psychiatric patients and

supervising and educating the nursing staff. Leading groups and conducting

medication education. Performing EKGs and phlebotomy. Assisting with

updating quality control forms.

2001 - 2003

Cardiac Disease Specialists P.C. – Certified Clinical Research Coordinator

Responsible for coordinating and conducting all aspects of Phase II thru IV

inpatient and outpatient clinical drug and device studies within the field of cardiology. Performing EKGs and collecting and processing labs. Scheduling follow up care of research patients. Designing source documents for studies.

2000 to 2001 Peachtree Clinical Research (S.M.O.) – Senior Clinical Research Coordinator Responsible for supervising and conducting Phase II and III medical clinical research trials at Atlanta Diabetes Associates and other local private practices. Areas of studies include: Diabetes, Hypercholesterolemia, Chronic Renal Insufficiency with Anemia, Testosterone Deficiency in males, and Low HDL. Responsibilities included clinical trial coordination and office administration as a representative of the Site Management Organization.

MITTIE MITCHELL, R.N., B.S.N.

2000 - 2001

Wellstar Cobb Medical Center - Critical Care Staff Nurse

Managing chronically and acutely critically ill adult patients, requiring extensive

clinical expertise.

1995 - 2000

Carman Research – Senior Clinical Research Coordinator

Responsible for supervising and conducting more than 75 psychopharmaco-

logical clinical trials, phases IB-IV, from open to close and follow-up thereafter.

*Clinical Trial Coordination: Recruitment, screening, consenting, clinical

assessments, phlebotomy, EKG’s, CRF entry, drug accountability, internal

quality assurance, maintaining medical records, supervision of regulatory

functions, and tracking patients throughout the protocol. Designing source

documents for protocols. Sole liaison between the site and pharmaceutical

sponsors and CROs for assigned protocols. Responsible for all coordination and

supervision of the company’s first Phase I Bridge study.

*Office Administration: Responsible for organizing all company marketing,

community education and public relations activities. Conducting all training for

referral sources and hospital staff and performing all OSHA-related functions.

Developed and implemented the site employee orientation program and the

S.O.P. manual.

*SKILLS: Certified diagnostic rater for SCID (both Axis I and Axis II

diagnoses), Sigh-A, Sigh-D, Hamilton Depression Scale, Hamilton Anxiety

Scale, Montgomery Asberg Depression Scale, Young Mania Rate Scale, SADS-

C Scale, PANNS, BPRS, and other rating scales for Schizophrenia and various

cognitive scales for Alzheimer’s Disease.

EDUCATION:

1989

Kennesaw State College - Bachelor of Science in Nursing

Licensure and Certification:

Registered Nurse (# RN 093952)

Psychometrician for Alzheimer’s Disease

DSM-IV SCID Interview

IATA, GCP

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