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Robert Lee Cook III

1832 Edison Dr.

San Antonio, TX 78201

(210) 332-7757

rlcook007@gmail.com

______________________________________________________________________

Therapeutic Experience:

Professional Experience: Certified Clinical Research Coordinator 11/2013-The Texas Liver Institute (Phase 1, 2, 3, & 1

st in Human Studies)– San Antonio, Texas

Conduct In-house Monitoring of other site coordinator’s source documents, CRFs, ICFs and other study regulatory documents.

Prepare for future sponsor and/or FDA audits by conducting periodic audits of closed studies.

Strategically plans and meets with potential sponsors at Pre-Site(Site Qualification) meetings.

Certify that ALL regulatory documents are submitted to the IRB and sponsor in a prompt manner.

Maintains regulatory binder including the 1572, Protocol, IB, ICF, FDF, CVs, Licenses, IRB approved study documents, Patient recruitment materials, Laboratory ref. ranges, Lab personnel credentials, CLIA/CAP certifications, Central laboratory credentials, IATA certificates, Protocol training and study site delegation logs, Laboratory processing manual.

Attends Investigator meetings with Investigators and facilitates SIVs with sponsor representatives and documents issues requiring clarification.

Meets with source document writers, lab personnel, investigators, CRO/Sponsor, central/local labs, and pharmacy to confirm that ALL:

Sources are created according to EDC & Protocol guidelines. Reconciliation of lab kits to make sure nothing is missing from them. Drug is received and accounted for.

Pre-Screen and contact future subjects, according to medical records, that meet Inc/Exc criteria.

Provide weekly updated pre-screen/screening logs to Sponsor and attend conference calls to further update CRA and sponsor.

Screen subjects, complete the ICF process, draw lab specimens, obtain vital signs, complete ECGs and specimen processing portion of screening visits.

Contact CRO/sponsor to obtain randomization #s for qualified subjects and assist pharmacy with drug accountability on Day 1.

Maintain strict ICH/GCP clinical trial guidelines at every step of the clinical trial process.

Ensure that subjects adhere to all study visit calendars and all Follow-up visits.

Meet with CRA at scheduled date and times for monitoring visits. Review monitor reports with CRA, and complete/correct all deficiencies in the reports. Discuss any protocol deviations with CRA, report these to the site’s IRB, and Implement a corrective action plan to prevent future deviations.

Input study visit CRFs in the EDC system according to the sponsor-site contracted time frame, while verifying that the EDC system is an exact reflection of the site source documents.

Report any AEs and SAEs to the sponsor and IRB within specified time frames.

Complete close out visit with CRA as well as IRB and send back or destroy all study medications and remaining study kits in accordance with sponsor guidelines.

Oncology 5 years

Neurology 3 years

Cardiology 5 years

Immunology 4 years

Pulmonology 5 years

Gastroenterology 2 years

Osteopathy 2.5 years

Hematology 2 years

Nephrology 3 years

Endocrinology 5 years

Hepatology 5 years

Infectious Disease-4 years

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Research Scientist Associate 02/2011-11/2013 University of Texas at San Antonio – San Antonio, Texas

Supervise and care for the specialized Biophotonics Advanced Imaging & Analysis Laboratory.

Oversee the use and repair of the laboratory’s microscopes and projects, under the supervision of the director.

Collaborate with Principal Investigators in development of Pre-Clinical Trials and Study Imaging Protocols.

Provide guidance to all grad students, post docs, and PhD’s to use the multi-photon, the confocal fluorescence, and the live cell incubation microscopes. (Zeiss 510 & 710)

Assist grad students, post docs, and PhD’s in the use of laboratory’s imaging technology, in order to conform to study protocols and lab SOPs

Instruct lab personnel on proper utilization of imaging and analysis software to process data collected from the microscopes for publication purposes.

Organize and Facilitate workshops that take place in the Advanced Imaging & Analysis lab.

Assist in website maintenance and operation for the imaging lab.

Clinical Biochemical Laboratory Analyst 06/2009-02/2013 United Esoterics Laboratories – Woburn, Massachusetts

Independently Ran and supervised an offsite laboratory in Houston, Texas.

Perform onsite Micro- ELISA's, serum enzymatic endpoint type chemistries, enzymatic urinalysis, and advanced coagulation testing.

Created and perfected existing Standard Operating Procedures (SOP’s) to fit the companies growing testing needs.

Conducted quality control, maintenance, and proficiency testing to maintain compliance with CLIA.

Developed an interactive Microsoft Excel spreadsheet, for my lab, that was later adopted by the entire company to meet the needs of heavy patient volumes and high doctor demands.

Used careful planning and time management to facilitate great outcomes from myself as well as others in the laboratory in areas such as: Patient handling, Patient Privacy, Lab cleanliness, accurate testing, and data report results.

Effective multi-tasker able to coordinate the development of long term or daily projects, tasks and goals.

Nuclear Medicine Technologist 05/2008-12/2008 VA Hospital – San Antonio, Texas

Conducted Nuclear Medicine studies on patients looking for malignancies, lesions, and adenomas.

Processed images taken and discussed them with the attending doctor.

Performed therapies with a doctor for patients with hyper/hypo thyroidism, as well as bone pain.

Adhered to all hospital SOP’s, JCAHO guidelines, and OSHA regulations in the use and maintenance of radioactive materials.

Followed hospitals infectious control program to inhibit the spread of infections such as MRSA.

Conducted daily Quality Control test on all machines to verify their operating conditions.

Started IV’s, and became efficient at injecting patients with radioactive isotopes while protecting myself, and not harming the patient.

01/2008-2/2008 San Antonio Cardiology Clinic – San Antonio, Texas

Worked as a Nuclear Medicine Technologist performing Myocardial Perfusion Studies (Stress

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Tests') for about 10 doctors.

Became very efficient with my time on scanning the patients, making sure they got where they needed to go, as well as processing their results in a timely fashion.

Processing of the results were conducted according to each doctors’ preference.

Achieved proficiency with clinics software and cameras.

Started large numbers of IV’s and injected radioisotopes through them during cardiac stress tests.

Education:

Bachelors of Science - May 2009 University of the Incarnate Word, San Antonio, Texas Double Concentration: Biology and Nuclear Medicine

Professional Development: Barnett 10-week CRA Beginner Program Series

CITI Clinical Trials Training Modules: o Belmont Report and CITI Course Introduction o History and Ethical Principles o Basic Institutional Review Board (IRB) Regulations and Review Process o Informed Consent o Social and Behavioral Research (SBR) for Biomedical Researchers o Records-Based Research o FDA-Regulated Research o Conflicts of Interest in Research Involving Human Subjects

“Research Centers in Minority Intuitions International Symposium on Health Disparities in Minority Populations” in San Juan, Puerto Rico.

“8th International Weber Symposium on Innovative Fluorescence Methodologies in Biochemistry

and Medicine” in Kauai, Hawaii.

UTSA Confocal Fluorescence, Multi-Photon, and Live Cell Imaging training on Zeiss 510 & 710

Phlebotomy certification through Wilford Hall Medical Center

Texas Cancer Clinic PET/CT training

GE Healthcare Radiopharmacy training

Professional Organizations: Association of Clinical Research Professionals (ACRP), Certified Clinical Research Coordinator

Publications: Raghunathan, R., Mahesula, S., Kancharla, K., Janardhanan, P., Jadhav, Y.L.A., Nadeau, R.,

Villa, G.P., Cook, R.L., Witt, C.M., Gelfond, J.A.L., Forsthuber, T.G. and Haskins, W.E. Anti-CRLF2 Antibody-Armored Biodegradable Nanoparticles for Childhood B-ALL. Part. Part. Syst. Charact. 2013; doi: 10.1002/ppsc.201200125. Epub 2013 Feb 27.

Poster/Oral Presentations: RCMI International Symposium on Health Disparities

“RCMI Biophotonics Core: A Revolution in the Life Sciences”

San Juan, Puerto Rico. December 9-13th 2012.

Computer skills:

Experienced with the Medidata, Oracle, InForm, Express, and EXPeRT Data Capture Systems.

Outstanding knowledge of Microsoft Office with concentrations in Excel, PowerPoint, Word, and Outlook.

Proficient in using Apple software i.e. Entourage, Apple Mail, Apple Calendar, etc.