
Clinical Research / Administration / Laboratory Medicine
Washington D.C. Metro Area

Clinical Research / Administration / Laboratory Medicine
Washington D.C. Metro Area
CAREER OBJECTIVE:
I desire an opportunity to work with a company where I can utilize my diverse abilities. I am open to exploring employment opportunities in all areas of healthcare, as well as outside the industry.
SUMMARY OF QUALIFICATIONS:
· Dedicated, versatile professional, with proven organizational and administrative skills
· Team player and able to work independently
· Greater than 10 years experience in administration, laboratory medicine and clinical research
· Additional experience in retail sales, coordinating multiple projects, as well as diverse knowledge of computer software programs and data websites
LABORATORY: collecting, processing, coding, aliquoting and storage of blood specimens: adult and pediatric phlebotomy in emergency rooms, ICU, CCU, outpatient clinics, and routine patient floors. Performing simple laboratory test.
CLINICAL RESEARCH: Conducted >50 Clinical Research Trials (Phase I-IV) - CNS, Psychiatry, Infectious Disease, Vaccine, Educational and Device studies. Beginning with the Pre-Site Visit and ending with the Closeout visit. Lead contact for >5 FDA Audits.
(Research industry)
2005 — 2007 (2 years )
Q/A of Source Documents and CRFs; Implementing laboratory compliance, procedures and setup; Transcription of CRFs (computerized and paper); Creating study forms (source documents, CRFs, logs, etc.); Monitoring Drug Accountability; Consenting subjects; Interviewing potential new employees; Attending Investigator Meetings and preparing presentations for the Clinical Research Team; Resolving Study Queries; Preparing and reviewing recruitment scripts; Performing Vital Signs, ECGs, Phlebotomy; Responsible for reporting SAEs to Sponsors and IRB; Supervision of 2 study staff; Monitoring and Tracking Enrollment; Training subjects on use of take-home diaries, dosing with study drugs, etc.During the past year, coordinated 12 clinical research trials: adult schizophrenia (7), adult bipolar (1), adolescent schizophrenia (1), adolescent bipolar (1), hypertension (1) and osteo-arthritis (1). Also trained new research staff and managed day-to-day operations of a new CRU, from May to August, 2007.
(Public Company; 51-200 employees; Biotechnology industry)
July 1999 — May 2003 (3 years 11 months)
Q/A of Source Documents and CRFs; Maintaining Investigator Binders; Implementing laboratory compliance, procedures and setup; Transcription of CRFs (computerized and paper); Performing evaluations and testing on study patients (including cognitive testing); Creating study forms (source documents, CRFs, logs, etc.); Monitoring Drug Accountability; Consenting subjects; Attending Investigator Meetings; Resolving Study Queries; Preparing and reviewing recruitment scripts; Performing Vital Signs, ECGs, Phlebotomy; Monitoring and Tracking Enrollment; Training subjects on use of take-home diaries, dosing with study drugs, etc. During the past year, coordinated 6 clinical research trials; edited recruitment scripts and prepared for an internal audit. Number of studies completed at IMR now total 20. Promoted twice since hired by IMR. Managed all site activities as IMR prepared to close, including the review and archiving of all prior studies (greater than 100); overseeing five current trials.
(Public Company; 51-200 employees; Biotechnology industry)
October 1998 — June 1999 (9 months)
Supervision of 12-employee team; managing office; developing and implementing office systems and procedures; coordination of communications between site and company headquarters in Austin, Texas; planning, implementing and tracking budget and expenses; creation and purchase of print and broadcast advertisements; interviewing and selecting laboratory and office staff; creation of forms, graphs and flow charts; conducting in-services on phlebotomy; formulating training programs for employees; reorganized staff and operations in order to gain better office and lab efficiency; created laboratory reference and policy/procedure manuals. Performed CRC functions as needed (recruitment/consenting, transcription, data entry, source document preparation, laboratory, phlebotomy, insert HepLocks for PK studies, etc.)
(Health, Wellness and Fitness industry)
January 1996 — October 1998 (2 years 10 months)
Phlebotomy (adult and pediatric); performed laboratory tests; Accessioning Supervisor of five staff (as needed); reviewed laboratory results and answered client questions relating to tests and results; data entry using "HEX" system software; troubleshooting computer software problems; reviewed
(Public Company; 1-10 employees; Consumer Services industry)
July 1994 — December 1995 (1 year 6 months)
Interviewed, hired and supervised two employees; created advertisements and marketing promotions; inventory maintenance; data entry using Breeze/Windows software; retail sales.
(Public Company; 1-10 employees; Consumer Services industry)
November 1992 — December 1995 (3 years 2 months)
Responded to calls on a multi-line console for a 242-unit condominium tower (26 professional offices, 216 residential units); greeted and directed general public; typing correspondence; filing.
(Public Company; 1001-5000 employees; Hospital & Health Care industry)
September 1989 — December 1991 (2 years 4 months)
Phlebotomy (adult/pediatric) in the following settings: emergency room, ICU, CCU, outpatient clinic, and routine patient floors; performed pre-admission/post OP testing in outpatient clinic; processed blood specimens and ordered laboratory tests with computer assistance.
(Non-Profit; 10,001 or more employees; Non-Profit Organization Management industry)
June 1989 — September 1989 (4 months)
Processed blood specimens (coding, aliquoting and storage); reviewed, edited and entered laboratory data; maintaining Q/A records; performed reagent preparation; inventory maintenance.
(Non-Profit; Research industry)
February 1986 — June 1989 (3 years 5 months)
Performed clinical and administrative duties for research studies; recruited, interviewed and consented volunteers for research studies; obtained medical histories, performed pre-admission testing (vital signs, ECGs, throat and nasal cultures); phlebotomy (adult/pediatric), processing and storage of blood specimens, operation of centrifuge/autoclave, maintained specimen/volunteer log books; performed laboratory tests, reagent preparation; data entry using Paradox/Lotus software; collected/analyzed laboratory data; maintenance of laboratory (sterilization of instruments, ordering supplies and equipment); assisted in protocol development, preparation of budgets and correspondence; development of forms and research study advertisements; supervision of phlebotomy team.
(Public Company; 501-1000 employees; Hospital & Health Care industry)
June 1987 — September 1987 (4 months)
Project planning and development; coordinated employee/patient schedule; responsible for collecting, processing and storage of blood specimens from research participants; reviewed and edited all study data.
(Educational Institution; 201-500 employees; Higher Education industry)
June 1987 — September 1987 (4 months)
Implemented programs at college Reading Center, conducted reading placement tests; coordinated class schedules, prepared lesson plans and activity packets for students, maintained inventory of reading center study materials; typed correspondence. (Also served as receptionist for Human Development Division, responding to calls on a multi-line telephone console, communicated college course/program information to students; transcribed counseling sessions; typed correspondence, Summer 1995).
Music: All Kinds, Symphony, Opera, Theatre, Games: Canasta & Scrabble, Art: Collecting and Museums, Running & Cycling, Gardening: Indoor, Outdoor-Potted and Water, Books, Antiques, Current Events, Social & Political Issues, Walking Tours of Cities, Wine, Religion and My Friends