Clinical Research Medical Records

LAWRENCE PORCO

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

Dingmans Ferry, PA. 18328

570-***-****; 718-***-****; cell 646-***-****

*******@*****.***

EDUCATION: M.S. in Pharmacology/Toxicology St. John’s U. Jamaica, N.Y.

M.S. in Biology (Cytogenetics) Fordham University Bronx, N.Y.

B.S. in Biology (Pre-Med) Fordham University Bronx, N.Y.

The Bronx H.S. of Science

HONORS AND AWARDS:

U.S. Customs monetary award for updating narcotics inventory and assisting the Petroleum Chemist in inspecting private gauging laboratories.

Member of Rho Chi Honor Society with 8 straight A's in graduate courses (St. John's Univ.).

· Made the Dean's List with a GPA 3.5 or higher (Fordham University graduate prgm.)

EXPERIENCE:

Clinical Research

Involved with Phase I studies for transdermal patch testing. Traveled with experienced monitors to various domestic sites and observed the study while it was being conducted.

Compared data in the Case Report Form against the medical record to validate the data.

Reviewed the medical records to ensure all adverse experiences were recorded on the Case Report Form and appropriately reported.

Reviewed the documentation included in the site’s study file.

Participated in Interim Monitoring Visits.

Reviewed informed consents, study protocols, investigator agreements, and CRFs as well as patient lab reports for inclusion/exclusion criteria for study enrollment. I have reviewed many of the documents contained in TMFs.

Used Siebel’s eClinical as the remote data capture software and worked with Documentum.

Therapeutic Areas

Oncology: Performed tumor implantation and transfers in rats and nude mice models. Isolated human megakaryocytes and studied their cell surface proteins for cancer markers.

Hormonal biochemistry: Studies methods for early detection of breast cancer.

Molecular Biology: Studied 3T3 fibroblast cell transformation by modified Moloney MLV with Abelson genome measured by tyrosine kinase activity.

Hematology, Clinical Chemistry, and Urinalysis: Interpreted qualitative and quantitative values for clinical chemistry tests and reported these results and interpretations to appropriate hospital staff. Performed emergency blood and urine drug test analyses for local hospitals. Worked in the Blood Bank to type and crossmatch patient samples and issue blood components.

Pharmacokinetics: Performed pharmacokinetic studies measuring carbon-14 labeled compounds distributed in animal tissues. Extracted cold test compound metabolites from various animal plasmas in preparation for analysis.

Oral and Written Communications

Assisted in the writing of Standard Operating Procedures (SOPs) for a variety of lab equipment.

Wrote SOPs for Narcotics handling concerning their acceptance, storage, analyses, chain-of-custody, and disposal in the lab.

Wrote many management briefs informing the US Customs Lab Director and other Government personnel of outstanding monetary (tariff) changes in imported goods upon sample testing completion and other noteworthy items of analytical interest.

Interpersonal and Supervisory skills

Worked as a supervisor in various positions: over ten toxicology chemists on a toxicology floor of a state lab, two night shift clinical toxicology technicians in a private full-service medical lab, and five technicians in the Thin-Layer Chromatography section of a private urine drug screen lab.

Worked as part of a narcotics destruction committee at the US Custom Service Lab which oversaw the random drug analysis of narcotics and their disposal via incineration.

Interacted on a routine basis with a large variety of hospital personnel including physicians, nurses, and aides reporting lab test results to the wards and with patients in the capacity of house messenger for over 20 years.

Involved with the US Customs Lab Open House demonstrations of the analytical instrumentation and methods of analysis used for the study of imported products to the private industry, the public, and other government personnel with in-house activities and outside mobile lab fairs.

Demonstrated to other US Customs personnel the use of the preliminary narcotics test kits used by field agents.

Computer skills

Microsoft Access, Excel, Word, Outlook; Lotus Notes

LICENSES:

New York City Department of Health

Clinical Laboratory Supervisor: Area 33C – Forensic Toxicology

Clinical Laboratory Technologist:

Area 30 – Therapeutic Substance Monitoring / Quantitative Toxicology

Area 33 – Drug Analysis: Qualitative (Routine)

Area 33A – Emergency Toxicology

Area 33C – Forensic Toxicology

EMPLOYMENT: (All Full time 40 hr/wk. min. positions)

8/13 – present U.S. Postal Service Rural Carrier (Mailman) Bushkill, PA.

Case and deliver the local mail with personal or company vehicle.

3/24 - 3/25 Atlantic Health Systems at Morristown Medical Center, NJ

Medical Lab Scientist I

Analyze bodily fluids via manual and automated techniques in a hospital setting using Dimension Vista 1500 analyzer.

2/13 – 5/13 Antech Diagnostics Lab, Lake Success, LI, NY

Temp. Veterinary Medical Lab Technologist Generalist Floater

Operated Beckman Olympus 640/680 Chemistry analyzers, Advia 120 Hematology analyzer, Bayer Clinitek Atlas & Adventus Urinalysis analyzers, Siemens Immulite 1000 analyzer, and Trinity Biotech KC4 Delta Coag unit.

Traveled as a FT vacation/sick relief floater working at the various company satellite STAT labs analyzing urine, blood, and serum samples from veterinary clinics and hospitals.

11/03 – 12/12 NYC Transit, Brooklyn, N.Y. Rapid Transit Operations

Operate subway trains as a Motorman in revenue and non-revenue service in the IRT Division.

Took this job due to a 9-month layoff from pharma industry with no prospects for employment. Would consider another permanent CRA position again.

9/02 – 3/03 Barton & Polansky Associates, NYC, N.Y.

Layoff Division of ICON Clinical Research

Clinical Research Associate as In-House Monitor

· Worked on Phase IIIb/Expanded Access anti-HIV study enrolling patients (5 pts/site;40 sites).

· Made monitoring calls in lieu of actual site visits; reviewed regulatory documents for accuracy; wrote monitoring call reports, also confirmation and follow-up letters to the site; on behalf of site requested exemptions from sponsor for patient enrollment and reported protocol deviations/violations to sponsor; followed patient SAEs obtaining discharge summaries, labs.

8/01 – 4/02 Ingenix Pharmaceutical Services, Basking Ridge, N.J.

Clinical Research Associate as In-House Monitor

· Worked on Phase III, IV, and Expanded Access anti-HIV studies.

· Coordinated patient enrollment based on inclusion/exclusion criteria; generated queries to investigators; interfaced between study sites and sponsors; issued regulatory documents; proofread protocols, case report forms, investigator agreements, informed consents.

2/01 – 8/01 Purdue Pharma, L.P.; Stamford, CT.

Temp. Regulatory Affairs Associate in International Reg. Affairs

Provided assistance to the Drug Safety, Labeling, & Biostatistics Depts.

· Responded to inquiries from various overseas affiliates requesting drug product registration Information. Prepared and supplied CMC data and information for annual reports.

· Organized patient files and sorted them by adverse events in drug safety.

· Maintained labeling inventory database entering and issuing labels, containers, and patient inserts. Proofread labeling corrections and obtained approval signatures.

· Reviewed and compiled statistical doc. notebooks for 4 drugs to comply with dept. SOP.

7/00 – 11/00 Regeneron Pharmaceuticals, Inc.; Tarrytown, N.Y.

Temp. Research Associate in Pharmacokinetics/Transgenic Mice Groups

· Performed PK studies with rats and mice (dosing and canula/tail bleeds) involving anti-cancer and anti-obesity test compounds.

· Collected the serum and analyzed via ELISA.

· Worked in the mouse transgenic group utilizing embryonic stem cells, PCR, and Southern blots to study knockouts to identify various gene functions.

3/99 – 2/00 Bronx Veterans Administration Hospital Laboratory; The Bronx, N.Y.

Clinical Laboratory Technologist in Chemistry, Hematology,

and Blood Bank

Issued blood component units upon request and analyzed blood/urine in chem. and hem. depts.

6/98 – 10/98 Lederle Laboratories (Wyeth-Ayerst Research); Pearl River, N.Y.

Temp. Drug Safety and Metabolism Chemist in Drug Disposition Department

· Performed pharmacokinetic studies measuring via Packard automated tissue oxidizer and scintillation counter novel carbon-14 labelled compounds distributed in animal tissues.

· Extracted cold test compound metabolites from various animal plasmas preparing them for HPLC and LC/MS analyses.

· Kept updated study logbooks and interfaced with other departments concerning studies.

9/91 – 4/98 U.S. Customs Service Laboratory; New York, N.Y.

Regulatory Analytical Chemist in Chemicals Branch

Analyzed smuggled narcotics for interdiction & imported legal commodities for tariff purposes.

9/84 – 4/85 Ayerst Laboratory; New York, N.Y.

Medical Research Associate in Bioavailability (Phase I) Group

· Worked in the Bioavailability Phase I group in the areas of oncology and endocrinology.

· Organized Phase I studies for transdermal patch tests of a steroid compound.

· Traveled to various domestic sites to monitor clinical drug trials.

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