Q/A of Source Documents and CRFs; Maintaining Regulatory Documents and Investigator Binders; 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.

Q/A of Source Documents and CRFs Maintaining Regulatory Documents and Investigator Binders; Implementing laboratory compliance, procedures and setup; Transcription of CRFs (computerized and paper); Performing clinical assessments, evaluations, and testing on study patients (including cognitive testing); 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 4 study staff; 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; trained new research staff; edited recruitment scripts; developed FAQs for the general public; and prepared for an internal audit. Also developed tools for time management and for tracking employee performance. Involved in meetings with investigators to determine future research studies. 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; and handling all regulatory affairs.

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.)

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 and maintained quality control records.

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.

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.

Course of Study: Computer Programming