Aaron R. Baker

acehe0@r.postjobfree.com

**** ********** ***.

Tampa, FL 33629

813-***-****

Education

**/**-**/** *********** State University

Boone, NC

Master of Arts Degree

Major: Clinical Psychology

06/98-06/04 University of South Florida

Tampa, FL

Bachelor of Arts Degree

Major: Psychology

Professional Experience

5/13-9/13 Pediatric Epidemiology Center

University of South Florida

Clinical Research Administrator, TrialNet

Serve as an excellent and thoroughly knowledgeable expert resource for

assigned protocols. Effectively manage demands on time to remain accessible

and approachable for external site staff questions and concerns. Respond to

all internal and external customers inquiries within established project

guidelines.

Assist in protocol development and oversee/assist with electronic case

report form (eCRF) design- obtain and maintain regulatory compliance

approval for the grant as a whole to ensure compliance to all standards,

policies and quality measures. Assist project site staff's navigation of

online media center and training presentations. Create new project member

logins and accounts- assign appropriate permissions and protocol roles

within the online system/protocol tools- disseminate new user account

information (login and password) to new users. Maintain general lists at

the PEC and within online protocol tools of project roles and personnel

(e.g. online Adverse Event System general roles). Secure, maintain, and

update public web site and contacts from the project. Test study website

for defects as needed.

Utilize project resources and serve as an individual contributor to develop

operational policies,

resource documents, and training documents- including the documentation of

best standards and practices. Continuously update the policies, resource

documents, and training documents to ensure team assigned to the project

has the needed documentation to undertake the task. Prepare initial

training agenda for onsite/offsite/remote training sessions. Assist in

creation of training binders. Reconcile training attendee list with site

delegation logs, update appropriate training tracking/status reports.

Review the training status of new users (as needed) and communicate to the

project sites, staff, and PEC necessary training requirements. Preparing

agendas and drafting/finalizing meeting minutes.

Defines and disseminates methods for communication of project status.

Communicate project goals, monitor project progress, and adjust resources

as necessary to keep the project on track. Disseminate learned information

to fellow team members as well as staff assigned to the project. Keep PEC

staff members updated on study site staff additions, training requirements,

document filing, document posting, systems updates, data inconsistencies,

quality of data, etc.

Communicate with study sites to resolve data inconsistencies. Review data

reports produced by the PEC for accuracy and completeness. Verify data

submitted through hard-copy CRFs and online system as needed. Enter data

from contact registry forms or other hard-copy forms (or other systems)

into secure online system. Receive, review, track, file, and enter site

data deletion and range change requests from project sites/centers. Monitor

faxes received to the main project fax line. Responsible for supply

ordering and related documents- tracking supplies ordered through systems

and vendors, following up on orders and completing necessary forms. Provide

feedback to sites/clinical centers and vendors regarding the status of

orders. Maintenance of supply lists and assisting PEC staff with related

responsibilities.

Attend project specific and steering committee meetings to represent the

team and be a source of information for any questions that may arise.

Report requests and solutions to those requests to the project lead/PI.

Follow-through with any meeting related request to ensure proper

implementation. Assist with the creation of meeting minutes in a timely and

detailed fashion. Track the status of minutes and communicate to PEC and

project stakeholders as to bottlenecks and progress of minutes creation.

6/12-5/13 Comprehensive Clinical Development

Miramar, FL

Network Coordinator

The Network Coordinator plans, directs and coordinates network

study activities. This position participates in the operational

planning, scheduling and implementation of Oncology, Neurology, CNS

and Internal Medicine trials with approved Network Sites. The

Network Coordinator is the liaison with internal and external

parties to manage the overall clinical Network project and timelines

ensuring planned deliverables are executed and within planned

budget.

Performs as the primary contact in conjunction with the Executive

Director and liaison between the Network, Sponsor and study Sites to

ensure the safety of subjects, accuracy of data, adherence to Good

Clinical Practice (GCP) standards, Standard Operating Procedures

(SOP's), quality (QA/QC) procedures, OSHA guidelines and other state

and local regulations as applicable, ensuring strict compliance to

the study protocol at all times and operational success of the study

and project.

Plans and oversees assigned studies ensuring appropriate

communications, documentation, administrative processes, enrollment,

monitoring activities, and work submission; tracks timelines and

completion.

Participates in project level budget planning, review and tracking

of deliverables.

Provides operational support as a member of the Clinical Networks,

Clinical Services and corporate office teams.

12/08-6/12 H. Lee Moffitt Cancer Center

Tampa, FL

Preferred Partner Project Manager

Responsible for establishing and managing a strong, effective working

relationship with multiple Moffitt Cancer Center departments and industry

partners participating in the Preferred Partner Program. Work with Clinical

Investigations team members and faculty to monitor and track all

relationship issues, including protocol activation, budget and project

progress, and other key deliverables. Function as the primary liaison

between Moffitt and each Preferred Partner, and communicate on-going

project status, potential issues, and timelines to Vice President of

Clinical Investigations and other center leadership as needed. Manage the

interface of all cross-functional departments, to perform project related

activities according to project timelines and milestones in a manner

consistent with the clinical trial process, Good Clinical Practice, Good

Laboratory Practice, FDA, HHS, OHRP, and ethical, transparent business

practice.

Also responsible for organizing and executing the annual Scientific

Exchange Day symposium to develop new lines of research with pharmaceutical

industry partners.

05/07-10/08 Stedman Clinical Trials

Tampa, FL

Clinical Research Coordinator

Responsible for obtaining IRB approval for consent forms, advertisements

and continuing review, attendance at Investigator meetings, subject

recruitment, review of medical histories and concomitant medications to

determine eligibility, consent of subjects and their caregivers (if

applicable), measurement of vital signs, performance of ECGs, laboratory

sample processing and shipment, dispensation and storage of study

medication, source documentation and transfer of data to both paper and

electronic case report forms, as well as maintenance of all regulatory

documents. Responsible for grant proposal writing and submission, as well

as design of 2 investigator-initiated research protocols. Responsible for

administering, scoring and interpreting numerous assessment instruments

including: HAM-A, HAM-D, MADRS, SCID-IV-TR, MINI, PANSS, MMSE, PAI, MCMI-

III, MMPI-2, ADAS-Cog, DAD, CANTAB, CDR-CAS, NPI, K-SADS, CIBIC+, CSDD,

MATRICS, ADCS-ADL, SIB, YMRS, C-SSRS and WMS-III.

12/06-05/07 Stedman Clinical Trials

Tampa, FL

Clinical Internship

Responsible for administering, scoring and interpreting numerous assessment

instruments including, HAM-A, HAM-D, MADRS, SCID-IV-TR, MINI, PANSS, MMSE,

PAI, MCMI-III, MMPI-2, ADAS-Cog, CANTAB, CIBIC+, CSDD, ADCS-ADL, SIB, YMRS

and WMS-III. Responsible for electronically capturing patient data.

Diagnosed and designed treatment plans and conducted 4-6 therapy sessions

with clients per week. Performed ECG's and lab specimen collection.

Processed and packaged lab specimens for shipment. Responsible for grant

proposal writing and submission, as well as preliminary design of an

investigator-initiated research protocol. Supervisor: Madeline Altabe,

Ph.D.

08/05-12/05 Appalachian State University

Boone, NC

Psychology Clinic

Responsible for administering a variety of assessment instruments

including, WISC-IV, WAIS-III, WJ-III, BASC-2, SCID-IV-TR, CTMT, WCST,

CAARS, STAIC, WRAT-3, BAI, BDI, and CPT. Co-authored 4 formal assessment

reports and was the lead report writer for 4 others. Provided interpretive

sessions with clients, explaining assessment results, possible diagnoses

and recommendations. Implemented individual treatment plans based on

diagnosis.

Supervisor: Hank Schneider, Ph.D.

01/05-06/05 Appalachian State University

Boone, NC

Counseling Center

Responsible for design of treatment plan, conduct of individual therapy

sessions with 6 clients per week, recording of case notes and maintenance

of client files.

Supervisor: Sheri Clark, Ph.D.

08/05-06/06 Appalachian State University

Boone, NC

Graduate Assistant

Assisted in publishing a comprehensive encyclopedia of child labor.

Responsible for locating contact information for potential contributors,

contacting chosen contributors and assisting contributors in the submission

process.

Supervisor: Hugh Hindman, Ph.D.

08/04-06/05 Appalachian State University

Boone, NC

Research Assistant

Assisted on a research project investigating the effect of proposed tort

reform laws on jury awards in cases involving punitive damages. Responsible

for gathering data, filing, email correspondence and data entry and

analysis using SPSS.

Supervisor: Paul Fox, Ph.D.

08/03-06/04 University of South Florida

Tampa, FL

Research Assistant

Assisted on a multinational research project with Siemens investigating the

effect of management style on creativity and innovation among employees.

Responsible for verifying accuracy of written transcripts of recorded

interviews, producing transcripts from recorded interviews, data entry,

coding interview responses for analysis and analyzing data using SPSS.

Supervisor: Johannes Rank, Ph.D.

01/02-08/02 University of South Florida

Tampa, FL

Research Assistant

Assisted on a dissertation examining emotional characteristics that affect

job performance. Responsible for helping to refine the instrument used in

the study, conducting interviews with research participants, training new

assistants and data entry using SPSS.

Supervisor: Jerry Miller, Ph.D.

Memberships

2004-2006 Psychology Graduate Student Organization

2002-2007 American Psychological Association, student affiliate

2002-2004 University Psychological Association

Certifications

CITI Protection of Human Research Subjects

NIH Human Participants Protection Education for Research Teams

IATA Infectious Substances/Dry Ice Shipping Certification

American Heart Association BLS for Healthcare Providers

OSHA Bloodborne Pathogens and Biomedical Waste Training

Research Experience

Personality Characteristics Determining Lapse vs. Relapse in a Population

of Dependent Cannabis Users

A Comparison of XXX vs. Placebo in the Treatment of Insomnia Associated

with Major Depressive Disorder (MDD) or Untreated MDD Relapse, when used

Concomitantly with XXX

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the

Effects of DHA on Cognitive Functions in the Elderly

A Multi-Center, Randomized, 8-week, Double-Blind, Placebo-Controlled study

followed by a 6-month Open-Label Extension to evaluate the Efficacy and

Safety of XXX in Peri- and Postmenopausal Women with Major Depressive

Disorder

A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian

Adaptive Design to Evaluate the Efficacy and Safety of XXX in Subjects with

Mild-to-Moderate Alzheimer's Disease on Stable Doses of

Acetylcholinesterase Inhibitors

A Double-Blind, Parallel Group Comparison of 23mg XXX Sustained Release to

10mg XXX Immediate Release in Patients with Moderate to Severe Alzheimer's

Disease

A Phase 2, Double-Blind, Placebo-Controlled Study to Evaluate the Safety,

Tolerability, and Effect on Cognitive Function of XXX after 12 Weeks of

Intranasal Administration in Subjects with Mild Cognitive Impairment

A 2-year, Prospective, Blind-Rater, Open-label, Active-Controlled, Multi-

Center, Randomized Study of Long-Term Efficacy and Effectiveness Comparing

XXX and XXX in Adults with Schizophrenia

A Phase 3 Multicenter, Randomized, Double Blind, Placebo Controlled Study

of the Effect of Daily Treatment with XXX on Measures of Cognitive and

Global Function in Subjects with Mild to Moderate Dementia of the

Alzheimer's Type

A Phase IV, Double-Blind, Placebo-Controlled, Randomized, Flexible dose of

the Safety and Efficacy of XXX in Adolescents with Major Depression

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to

Evaluate the Efficacy and Safety of XXXXXX at a Target Dosage of 200 mg/day

as Treatment for Adults with Excessive Sleepiness Associated with

Obstructive Sleep Apnea/Hypopnea Syndrome with Comorbid Major Depressive

Disorder or Dysthymic Disorder

A Randomized, Double-blind, Parallel-group, Placebo-controlled, Fixed-dose

Study Comparing the Efficacy and Safety of XXXXXX versus Placebo in Acute

Treatment of Adults with Major Depressive Disorder

A Double-Blind, Randomized, Placebo-Controlled, Multi-Center Study

Examining the Efficacy and Safety of XXXXXX in Subjects with Generalized

Anxiety Disorder

A Multi-Center, Multiple-Dose, Double-Blind, Randomized, Placebo-

Controlled, Parallel-Group Study of the Safety and Efficacy of Oral XXXXXX

Given Twice Daily for 4 Weeks for the Relief of Irritable Bowel Syndrome

(IBS) Pain

A Randomized, Double-Blind, Placebo-Controlled Study of XXXXXX (XXXXXX) in

the Treatment of Irritable Bowel Syndrome with Diarrhea (IBS-D)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety

and Effectiveness of XXXXXX in Female Patients with Irritable Bowel

Syndrome with Constipation

A Randomized, Double-Blind, Placebo-Controlled, Phase 2a Proof-of Concept

Study to Evaluate the Efficacy of Maximally Tolerated Doses of XXXXXX vs.

Placebo in Reducing the Pain Associated with Post-Herpetic Neuralgia

Open Label Study of the Effect of Daily Treatment with XXXXXX in Subjects

with Dementia of the Alzheimer's Type

An Open-Label Extension of the Phase III Study XXXXXX with XXXXXX in

Patients with Alzheimer's Disease

A Phase I investigation of XXXXX and XXXXX with XXXXX in Patients with

Advanced Solid Tumors

A Phase I Investigation of the Safety, Tolerability and Immunogenicity of

XXXXX in Cancer Patients with Selected Solid Tumors

A Phase I Study of XXXXX, a Notch Inhibitor, in Patients with Metastatic or

Locally Advanced Breast Cancer and Other Solid Tumors

A Phase I Dose Escalation Study of XXXXX in Patients with Locally Advanced

or Metastatic Solid Tumors

A Phase Ia Study of XXXXX in Patients with Advanced Solid Tumors and Phase

Ib Study in Patients with BRCA Mutant Ovarian Cancer

A Phase I Trial of XXXXX in Combination with XXXXX and XXXXX in Recurrent

Glioblastoma

Staining for IGFR Receptor to Determine Relative Frequency of Intensities

in a Likely Recurrent Population

A Study to Establish Proof-of-Biology for XXXXX in Breast Cancer

Activity and Targeting of Hedgehog Pathway in Multiple Myeloma

A Phase I Dose Escalation Study of XXXXX in Patients with Locally Advanced

or Metastatic Solid Tumors (including Basal Cell Carcinoma,

Rhabdomyosarcoma, Primitive Neuroectodermal Tumors)

A Clinical Trial to Assess the Effect of XXXXX (XXXXX; XXXXX) on QTc

Interval in Patients

The Growth Factor Signature (GFS) as an Intermediate Biomarker of Response

for Development of PI3K-Pathway Inhibitors in Patients with Breast Cancer

XXXXX with XXXXXXXX Unresectable Stage 3 or 4 Melanoma

A Study of XXXXXXXXXXX +XXXXXXX, XXXXXXXXXXX+ XXXXXXX, and XXXXXXXXXX +

XXXXXXX Combination Therapies in Participants with Advanced Cancer

Safety and Efficacy of XXXXX in Combination with XXXXXXXXXXX in Patients

With Relapsing HER2 Overexpressing Breast Cancer Who Have Previously Failed

Trastuzumab

A Phase Ib/II Study of XXXXXX and XXXXXXXXXX in Patients with HER2-positive

Breast Cancer

A Study of the Experimental Drug XXXXXX with XXXXXXXXXX in Patients With

HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or

Without PI3K Activation

Safety and Efficacy of XXXXXX in Patients with Metastatic Non-Small Cell

Lung Cancer

XXXXXX and XXXXXX in Adult Patients With Advanced Solid Tumors Harboring

RAS or BRAFV600E Mutations

Dose Escalation Study of XXXXXXXXXXX in Patients with Advanced

Neuroendocrine Tumors (NETs)

Study of XXXXXX in Patients with High Risk Smoldering Multiple Myeloma

Phase I Study of XXXXXX & XXXXXXXXX for Advanced Aerodigestive Tract

Cancers

XXXXXX and XXXXXXXXXXX in Advanced Pancreatic Cancer

Study of XXXXXXXXXXX Long Acting Release (LAR) in Patients with Metastatic

Neuroendocrine Tumors (NETs)

Histone Deacetylase Inhibitor XXXXXX in Addition to Corticosteroids in

Patients with Acute Graft Versus Host Disease

Phase 1 Study of XXXXXXX in Adult Patients with Advanced Gastrointestinal

Malignancies Expressing Guanylyl Cyclase C

Efficacy & Safety Study of XXXXXXXX to Treat Metastatic Colorectal Cancer

Trial of XXXXXXXXX in Subjects with Advanced Cancers Harboring DDR2

Mutation or Inactivating B-RAF Mutation

A Phase II, Randomized Study of Paclitaxel with XXXXXXXX versus Paclitaxel

with Placebo in Patients with Locally Recurrent or Metastatic Breast Cancer

(Additional research experience available upon request)

Aaron Baker, M.A. Date

Last updated 15/DEC/2013

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