1. Addie Brooks
US Regional
Lead CRA/Clinical Trial Leader
Biography
Addie Brooks, B.S, M.S.
Riverview, Fl. 33579
813-990-7882
INC Research Oncology Business Unit
Over 10 years’ experience in Clinical Research Organizations (CROs) as a LEAD CRA, Principal CRA
and Senior CRA in Phases I, II, III and IV of Clinical Research. With an expansive knowledge base of
Regulatory Compliance, specifications of Worldwide Guidelines and Data Management Experience.
Major accomplishments include:
Completion of Management Training Program, 2015
Completed LEAD Training Program 2013
THERAPEUTIC EXPERIENCE
Nervous System/Sense Organs: Multiple Sclerosis, Parkinson’s Disease
Respiratory: Chronic Obstructive Pulmonary Disease, Asthma
Digestive System: Clostridium Difficile Infections
Musculoskeletal: Rheumatoid Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis
Circulatory: Hypertension, Heart Disease, Drug Safety in Heart Transplant Patients
Infections/Parasitic Diseases: Hepatitis C, HIV
Oncology: Breast Cancer, Lung Cancer (Small cell & non-small cell), Acute Myelogenous Leukemia
Professional Experience
Nov 2015 - Present INC Research Raleigh, NC
LEAD Clinical Research Associate
•Completes project activities associated with monitoring functions of Phase I-IV clinical research studies.
•Demonstrates mastery and a deep understanding of the drug development process, Good Clinical
Practices (GCP), and relevant regulations.
•Provides clinical and technical support for Clinical Research Associates (CRA) I, II, and III and
administrative staff.
•Performs management of study site activities to ensure the integrity of clinical data, in adherence to all
applicable regulatory guidelines and Standard Operating Procedures (SOPs) and Project Specific
Operating Procedures including management of deviations, subject transfers, line listing reviews,
spreadsheets, CRA transitioning and additional deliverables .
•A Lead CRA (LCRA) on projects by providing direction and guidance to project team, coordinating all
monitoring activities, and communicating the status of these activities to the study Project Leader.
• Exhibits an advanced understanding and application of applicable therapeutic standards.
•Able to handle multiple tasks to meet deadlines in a dynamic environment.
CONFIDENTIAL Last Updated:24-Mar-2016

2. •Able to handle multiple tasks to meet deadlines in a dynamic environment.
Oct 2013 - Oct 2015 PPD Wilmington, NC
LEAD CRA/ Associate Manager
Worked closely with the Senior Project Manager to oversee the welfare of CRAs. Responsible for
evaluating CRAs’ performance and supporting their career growth.
•Ensure that CRAs are fully resourced and utilized on their projects
•Evaluate CRA performance
•Regular contact with the CTM/Senior PM
•Establish monthly meeting times
•Conduct performance assessment and provide feedback to CRAs
•Review visit reports for completeness and conformity with report guidelines
•Ability to develop productive communication and pinpoint areas of strength and development in CRAs.
•Probe and look for cues where quality may be at risk by reviewing the study monitoring plan or protocol
with CRA, and asking questions pertaining to ICF review processes and escalation pathways for the study.
•Worked closely with the CTM, to ensure that CRAs are being provided with consistent expectations and
clear direction on study processes.
•Developed action plans for disciplinary issues and evaluated continued performance
•Expert clinical monitoring skills
•Expert knowledge of FDA guidelines, GCPs and applicable Standard Operating Procedures
•Skills to mentor and train other monitors in a positive and effective manner
•Demonstrated ability to evaluate medical research data and proficient knowledge of medical terminology
•Implemented excellent oral and written communication skills
•Strong customer focus while displaying excellent interpersonal skills
•Excellent organizational and time management skills along with effective presentation skills
•Worked independently as required
•Able to utilize problem-solving techniques applicable to constantly changing environment
•Utilization of great English language and grammar skills
•Completed PPD Clinical Foundation Programme, Nov2014
•Completed PPD Respiratory Therapy Area Training Modules, Nov2014
•Completed PPD LEAD Training, Apr 2015
•Completed PPD CRA Management Training Program, 2015
Nov 2012 - Oct 2013 PPD Wilmington, NC
Principal/LEAD CRA
Works closely with the CTM to coordinate the activities of CRAs on the project team to ensure clinical
deliverables are met.
•Recommend processes to Clinical Management that optimize the use of project resources
•Provide mentoring and support to less experienced members of the project team and advice on training
and quality issues.
•Assist colleagues with site visits and site calls, when needed
•Serve as resource to team members with protocol, source document, CTMS, regulatory, data entry, and
query resolution questions and issues
•Completed On the Job Training, Lead team meetings, Conducted Training Sessions
•Assistive Management to Project Manager and Line Manager
Oct 2012 - Oct 2012 RPS INC Ft. Washington, PA
Senior Site Manager
•Adhered with corporate internal polices and requirements, including submission of timesheets and
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CONFIDENTIAL Last Updated:24-Mar-2016

3. expense reports in a timely manner.
•Knowledge of applicable SOPs, guidelines and study procedures;
•Assisted with protocol and CRF review;
•Developed informed consent forms;
•Conducted study feasibility and site selection activities.
•Assisted with the development of study manuals, annotated CRFs, monitoring conventions, tracking
forms, site study tools, and other study materials;
•Developed and implemented innovative approaches for and participated in site recruitment.
•Assisted with investigator meeting activities including organization, preparation and attendance
•Conducted site management activities, including but not limited to site selection visits, site initiation visits,
site training, site routine monitoring visits, and site close out visits.
•Ensured the integrity of clinical data and adherence to applicable regulatory, protocol, and company
guidelines.
•Established and maintain good rapport with study sites.
•Completion of study visit reports and follow up letters within the timeline established by applicable SOPs
and guidelines
•Coordinated timely shipment of clinical supplies and study drug to sites.
•Ensured proper storage, dispensation and accountability of clinical supplies and study drug.
•Maintained adequate site tracking records
•Followed up of drug safety issues and safety reports in timely manner, if applicable
•Communicated site study issues, concerns, and progress Project Manager, Clinical Team Lead, Regional
Monitoring Manager and Clinical Operations Manager accordingly
• Assisted with data query form (incl. query process)
• Performed telephone monitoring activities in order to obtain study status information
• Development and implementation of corrective actions when appropriate
•Prepared /review all patients tracking records
•Inputted and maintained study information concerning subject status of financial reimbursement to sites
•Conducted and assisted with administrative activities as a member of the project team
•Mentored for Site Manager, when assigned
•Conducted on the job training and formal training to other CRAs and Clinical Trials Assistants
•Collaborated with Regional Monitoring Manager or Clinical Operations Manager /study teams to resolve
site issues
•Reviewed study visit reports, follow-up letters and site communication generated by other CRAs for
timeliness, quality, consistency, and appropriate documentation and resolution of issues, with support from
Clinical Team Lead, Regional Monitoring Manager or Clinical Operations Manager as needed
•Participated in routine study progress meetings, face to face or via teleconference.
Jun 2007 - Oct 2011 Clintriad Pharma Services Exton, PA
CRA ll
•Conducted clinical site initiation visits as required, including advising and training site personnel on
Sponsor and regulatory requirements for study conduct.
•Conducted monitoring visits to perform on-site review of files and records for source document verification
and review of case report forms for completeness, accuracy and consistency; reviewed for protocol
compliance, regulatory compliance and drug accountability; identified deficiencies and/or discrepancies
and provide additional training and/or initiate corrective action as required; tracked essential documents
during the course of the study at assigned sites; performed follow-up to assist in resolution of significant
problems or issues noted during site monitoring visits.
•Prepared comprehensive and detailed reports documenting study status, site issues and monitoring
activities within specified timeframes
Jan 2006 - May 2007 Clintriad Pharma Services Exton
, PA
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4. CRA l
•Verified documented informed consent for each subject and assured the protection of the rights, safety
and wellbeing of human study subjects.
•Source Document Verification: Analyzed and evaluated clinical data, to ensure investigator and site
compliance with the study drug protocol, overall clinical objectives, and ICH Good Clinical Practice (GCP)
guidelines.
•Conducted accountability of investigational product during study visits and ensured the proper storage
and handling of investigational product.
•Assisted team members and clinical team leader (CTL) with designated administrative tasks in support of
clinical trial execution and management
•Maintained and managed data entry into subject enrollment tracking systems
•Prepared, managed and distributed clinical documentation and reports as needed
•Managed case report forms (CRF) and clinical data flow
Dec 2003 - Nov 2005 Veterans Administration, Bay Pines, FL
Veterans Manager
•Conducted interviews either in person or by telephone with veterans and other eligible individuals and
representatives to gather information to establish eligibility for veteran’s claims
•Accountable for proper analysis, appropriate development, authorization determination, and the thorough
preparation of cases
•Performed as a decision maker weighing the evidence and applying the controlling laws and regulations.
•Determined administrative decisions and special determination relating to qualifying military service
Dec 1995 - Sep 2005 United States Army Fort Benning, GA
Office Manager E-5
•Coordinated all administrative duties for military personnel office Operations.
•Maintained personnel folders, processing of promotions, payroll, personnel actions, clerical work, data
management, and quality control.
•Supervised and trained a team of ten office staff members.
•Awarded an Honorable Discharge and various medals for exemplary service.
•Received the Army Leadership Award and Physical Fitness Award
Therapeutic Experience
Analgesia/Anesthesiology
● Pain, Musculoskeletal
Cardiovascular
● Circulatory System
● Myocardial Infarction
● Pulmonary Hypertension
CNS Neurology
● Multiple Sclerosis
● Parkinson's Disease
● Rheumatoid Arthritis
Hematology
● Myocardial Infarction
Infectious Diseases
● Paediatric HIV
Inflammatory Diseases
● Psoriatic Arthritis
● Ulcerative Colitis
Oncology
● Cancer,Acute Myelocytic
● Cancer,Lung
Respiratory
● Asthma
● Cancer,Lung
● Chronic Obstructive Pulmonary
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5. Languages
English - Speaking, Reading, Writing
Native●
Education
2001-2003 Troy State University - United States
Masters - Health Administration
1998-2001 Columbus State University - United States
Bachelor - Health Science
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CONFIDENTIAL Last Updated:24-Mar-2016