Joshua E. Vinson

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

Pueblo, CO *1007

Phone: 314-***-****

abn9sl@r.postjobfree.com

Current as of Jan-2013

Colorado Research Works/CRx Clinical Research, Pueblo, CO

Trial Management Organization

Director/Study Coordinator 1/2011 - Present

Manage the implementation of study protocols in multiple therapeutic areas

Developing and maintaining business relationships with Pharmaceutical Sponsors, Site Management Organizations (SMOs) and Contr act Research

Organizations (CROs), with the main goal of building and maintaining a pipeline of clinical research trials. This included, responding to site feasibility

questionnaires, signing Confidentiality Disclosure Agreements (CDAs), collaboratively reviewing protocols with investigators for feasibility.

Management of accounts receivable/payable including all financial, payroll and tax reporting.

Cultivate strong working, collegiate relationships with multiple local contracted physicians (Investigators) and research staff implementing sponsor trial

requirements from concept to closeout.

Negotiate and execute Clinical Trial Agreements and budgets with Sponsor’s and CRO’s.

Managed all Regulatory and Institutional Review Board (IRB), initial and subsequent submissions and reporting, including reporting of Adverse Events,

Protocol Deviations, and Study Closeout.

Compile, complete, and submitting regulatory documentation as well as organizing trial regulatory binders ensuring completeness and accuracy. .Pe rform

drug reconciliation/accountability.

Design and implementation of subject recruitment campaigns, including negotiation of advertising budgets with Sponsors and CROs. Specifically, print,

internet, and direct mail campaigns. As well as internal database and investigator patient file review.

Developed site source documents as relevant to protocol requirements.

Conduct subject visits, as per protocol, including, informed consent process, blood and specimen collection and processing, performing

electrocardiograms(EKGs), administration of scales and questionnaires, and other protocol specific activities within my ability as per my scope of

training, as well as site and sponsor Standard Operating Procedures (SOPs), d ispense investigational product (IP), registration and randomization of

patients within IVRS. Instruct and monitor patients on use of investigational products, logs, IVRS, Diaries, and eDiaries as per protocol.

Maintain oversight of IP storage, access, accountability, and temperature monitoring technology, as per protocol and SOPs. Maintain laboratory and

clinical supplies, and equipment inventory and calibration logs.

Reviewing, and transcribing source documentation and medical records to complete Case Report Forms (CRF’s) as well as Electr onic Case Report Forms

(eCRF’s). Ensure the proper and timely review, by the Investigator, of labs and any requested medical records as received from other clinicians.

Review Data Clarification Forms (DCF) with Investigator and respond accordingly. Ensure the prompt completion and return to Data Management at

Sponsors and CROs.

Direct role in Initiation, Interim Monitoring, and Clo seout visits with monitors (CRAs). Additionally, act as a primary contact for monitors throughout

study.

Attended investigator meetings as well as other industry-related travel and training, as required.

OTHER EMPLOYMENT

ADVANCED FINANCIAL CONCEPTS, Covington, LA

Client Service Coordinator-2010-2011

AMERIPRISE FINANCIAL, Baton Rouge, LA

Client Service Coordinator-2005-2010

RESEARCH THERAPEUTIC AREA EXPERIENCE

Women’s Health

Gastrointestinal Blood Disorders

Surgical Pain

1

abn9sl@r.postjobfree.com

Joshua E. Vinson

1069 S. Lynx Drive

Pueblo, CO 81007

Phone: 314-***-****

abn9sl@r.postjobfree.com

Current as of Jan-2013

KNOWLEDGEABLE AND EXPERIENCED working with a wide variety of clinical trial support vendors

Electronic Data Capture (EDC): datalabsEDC, Domain Pharma, eTrials, Medidata, Oracle Remote Data Capture 4.6.2, Oracle Inform 5.0

Data Management: Clinical Trial Management System,ClinPhone, DATATRAK, Phase Forward, ClinSource, Fast Track Systems

Central Laboratories: CentraLabs, Covance, MedTox Scientific, LabCorp, Quest Diagnostics, CIRON Clinical Trial Services, Inc., ICON, LabConnect

Central Institutional Review Boards: Aspire IRB, New England IRB, Quorum IRB, Western IRB, Independent IRB, Essex IRB, Schulman IRB

Teleconferencing: MeetingOne, Microsoft Meeting, The Conference Depot, WEBEX

PROFICIENCIES

Applications: Apple OS X, Windows 7, Microsoft Office 2010: Access, Excel, PowerPoint and Publisher, Word (60wpm), Adobe Acrobat 9 and X.

Digital Photography: Canon G5, JPEG, TIF, BIT, CD burning, scanning, special effects, graphic arts and publishing .

EDUCATION AND TRAINING

Colorado Phlebotomy Certification, Colorado Springs, CO. 2012

Dangerous Goods International/HAZMT/ Shipping Training: FDA CFR 49. 2012

Formal Investigator GCP Training, 2011, 2012

American Red Cross, Basic Life Support for Healthcare Providers, 2012

Louisiana State University, Baton Rouge, LA. College of Basic Science, Biochemistry, 2004-2009

VOLUNTEER SERVICE

Private Medical Missions Volunteer-Roatan, Honduras-2012-current

Colorado Red Cross Disaster Medical Volunteer-2012-current

BLINDED CLINICAL TRIAL EXPERIENCE

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy And Safety Study Of Intra -Anal

Application Of XXX (10 Mg) As a 0.5% Ointment in Subjects With Symptomatic Internal Hemorrhoids

A Phase III, Open-Label Extension Trial of the Safety and Efficacy of XXX for the Episodic Treatment of Iron Deficiency Anemia

A Phase III, Randomized, Double-Blind, Placebo Controlled Trial of XXX for the Treatment of Iron Deficiency Anemia

A Phase III-B, Randomized, Double-Blind, Placebo-Controlled, Parallel-Treatment Group, Multicenter Efficacy And Safety Study Of Topical XXX

2% Cream In Subjects With Anal Fissure

Qualitative Interviews with Patients Diagnosed with Endometriosis

A Prospective, Single-blind, Randomized, Phase III Study to Evaluate the Safety and Efficacy of XXX as an Adjunct to Hemostasis During Soft

Tissue Open Surgeries

2

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