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Administrative Assistant

Location:
NY, New York, 11413, United States
Posted:
May 28, 2010

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Sandra Williams

***-** ***** ***

Springfield Gardens, NY 11413

oupe8q@r.postjobfree.com

347 ***-****

706 ***-****

Summary of Experience: 11 years of clinical research experience – 10 yrs Field monitoring of multiple Phase I – IV clinical trail sites and protocols. Conduct all types of monitoring visits to include PSV, SIV, Interim Visits, and Close-out visits. 9 yrs of EDC experience

Therapeutic Area/Indications

Diabetes, Oncology, Infectious Disease, Cardiovascular, Osteoporosis, Respiratory, MS/CNS, Hypertension/Dyslipidemia, Medical Devices, Genetics and Neuroendocrinology, Hormone Replacement Therapy, Women and Men Health, Pediatrics, Sickle Cell, Gene Therapy (Biological), Parkinson Disease, Renal Transplant, Cardiac Transplant/Stent, CHF, Orthopedics

Education

Bachelor of Science, 1991, Biology, Meadows College, Columbus, GA

Associate of Science, 1989, Medical Assistant, Meadows College, Columbus, GA

Awards: Dean's List, President's List

Professional Experience

02/2002 – Present

Clinical Research Management of Columbus, Columbus, GA

Clinical Research Associate/Monitor (Independent Contractor)

Field supervision and monitoring multiple clinical trial sites ensuring compliance with all regulatory agencies requirements including GCP, ICH, JCAHO, HIPAA, and FDA. Maintain sound clinical practices to ensure validity of study. Negotiate budget and contract process. Monitor the conduct and progress of studies to ensure compliance, protocol, and clinical study schedule. Conduct a variety of visits i.e. Pre-site, site initiation, interim, and close-out visits. Assist coordinators in preparing regulatory and IRB packets. Review onsite files, records, case report forms, and informed consent forms for completeness, accuracy, consistency, and compliance. Identify deficiencies and discrepancies and initiate corrective action. Analyze program and operational data, preparing reports and facilitating the integration of results into organizational operations. Ensure PI and coordinators are conducting study according to protocol, to include obtaining informed consent for applied research program, operational analysis functions including collection, storage, shipping of samples obtained from study subjects, study drug dispensing, collection and overall accountability. Prepare and submit appropriate reports in a timely manner.

08/1999 – 10/2005

Med-Care Urgent Care Center, Columbus, GA

Medical Assistant/Medical Technician (PRN Weekends)

Vital signs, triage, and charting patient history. Assist with minor surgical procedures utilizing sterile techniques. Clean, wrap, package, and sterilize instruments. Performing 12 lead EKGs, phlebotomy, and processing a variety of diagnostic laboratory tests. Administer medication via injections as directed by the physician or physician’s assistant. Process school, work, DOT physicals, and drug screens. Take and develop X-rays utilizing radiological knowledge of anatomy and positioning. Calculate the correct exposure setting in relations to the body part that is being x-rayed to ensure a well-developed view is obtained. Dispense and fill prescriptions from facility pharmacy and calling in prescriptions for medications not available on premises.

10/1998 - 02/2002

Naval Health Research Center, Ft. Benning, GA

Henry Jackson Foundation for Advancement of Military Medicine, (CRO)

Clinical Research Associate

Field supervise, monitor and oversee clinical practice for multiple clinical trials, ensuring compliance with all regulatory agencies requirements, regulations and guidelines including GCP, ICH, JCAHO, HIPAA, MEDDAC, FDA and Department of Army. Submit and maintain regulatory and IRB documents. Maintain sound clinical practices to ensure validity of study. Monitor the conduct and progress of the study to ensure compliance, protocol, and clinical study schedule. Review on site files, records, case report forms, and informed consent forms for completeness, accuracy, consistency, and compliance. Identify deficiencies and discrepancies and initiate corrective action. Analyze program and operational data, preparing reports and facilitating the integration of results into organizational operations. Responsible obtaining informed consent for applied research program. Conduct study visits in accordance with protocol, operational analysis functions including collection, storage, and shipping of the viral cultures and blood samples obtained from military basic trainees. Monitor multiple clinical trails simultaneously from start up/site initiation to close out. Sandra Williams, Clinical Evaluation of Two Rapid Diagnostic Tests for Influenza. 41st Interscience Conference on Antimicrobial Agents and Chemotherapy, 16-19 December 2001, Chicago, IL

10/1999 - 2/2002

Preventive Medicine, Ft. Benning, GA

Health Technician (Part-Time)

Perform counseling for patients who have been exposed to or who have contracted a sexually transmitted disease. Conduct interview and epidemiological investigation of patients with STD's as well as other communicable illness to include contact tracing, performing related diagnostic and treatment procedures such as applying liquid nitrogen for HPV patients. Plan, conduct interview to elicit information on the source of the STD, locate others exposed during the critical time period to assure timely intervention of the disease process and preclude dissemination. Initiate action to locate for medical evaluation all persons known to have been exposed. Make telephonic, written or personal contact with the named individuals. Provide in-depth marriage and sexual counseling to patients who have contracted an STD. Tailor counseling to meet the needs and circumstances of each patient to rehabilitate sexual behavior to preclude future disease. Encourage victims to report abuse and arranges for further counseling services as required. Provide standard public health information about other communicable diseases.

Obtain specimens from patients for cultures; wet preps and gram stain for analysis, herpes as well as Chlamydia and gonorrhea organisms. Prepare bacterial smears, examine microscopically for microorganisms. Perform microscopic examinations of vaginal secretions for trichomoniasis, yeast type infections. Prepares culture specimens, send to hospital laboratory for processing and examination. Conduct classes on the prevention of communicable disease at military units. Provide in-service training to military, civilians, and newly assigned physicians on the functions of the EDC. Disease surveillance and reporting. Operate and maintain the Reportable Medical Events System (RMES) and Epi-Info. Responsible for investigating disease outbreaks on Ft. Benning to determine source of outbreak. Reporting to federal and state agencies in a timely manner. Coordinated, scheduled, and conducted health education training.

07/1997 - 6/1998

GS5. Defense Finance and Accounting. White Sands, NM

Accounting Technician/Cash Clerk

Examines, verifies, and process disbursements, collections, and adjustment documents for the installation. Performs daily reconciliation of the EFT and treasury check register. Prepare and submit on a timely basis various special and periodic reports as required by regulation. Plan, organize and prioritize work in order to meet deadlines. Use automated system to transfer funds for travel and commercial accounts with an average of over 2 million dollars a day. Data entry of files and information for the Federal Reserve and US Treasury. Accountability of treasury checks, EFT process documents, and correspondence. Follow up on status reports to insure proper credit and EFT rejects. Maintain written and oral communication with various departments, divisions, and customers. Organize and maintain various files for audit and review.

08/1996 - 07/1997

OB/GYN Consultants, Las Cruces, NM

Medical Technician

Assisting physician with routine examinations such as pap smears, coposcopies, neonatal stress tests, and insertion and removal of birth control devices. Taking vital signs, patient history, and ordering labs and x-rays. Call in prescriptions, obtained patient authorizations from various HMO's and following standing order procedures (SOP) and standing orders. Triage of patients phone calls; prioritizing response from physician using medical knowledge and judgment. Performed OB interviews, insuring the appropriate lab work was done according to the patient’s gestation. Entered and informed patients of lab result; including the call back system for pap smears. Stocking rooms, inventory of supplies, cleaning, packaging, wrapping, Sterilizing (autoclave) instruments. In processing patients, scheduling appointments, pulling lab, x-ray, and medication information utilizing the hospital computer system. Preparing patients for pap smears and other exams as required. Performing urine sticks, preparing slides for pathology and other minor procedures such as suture removal, ear irrigations, and dressing changes. Assisted with the flexible sigmoidscopy procedure, including prepping patient, obtaining biopsies, cleaning and sterilizing the equipment valued at over $500,000. Processing insurance forms, medical coding for third party collection using the appropriate ICD and CPT codes.

02/1994 - 06/1996

Tripler Army Medical Center, Honolulu, HI

Orthopedic Technician

Fabricate, modify, and remove a variety of casts used to treat conditions and injuries of patient’s extremities. Such as short arms, long arms, short and long leg, ulnar gutter, radial gutter, cobra, munester, PTB, hip spicas, halo-pelvic, and hinged brace casts. Constructed plaster and synthetic casts for use in manufacture of various types of braces to treat abnormalities of extremities. I also assisted the physician by setting up instruments and medication for injections. Other duties included preparing patients for procedures in the cast room, emergency room, and the minor operating room. Review and charting of medical records. Ordering and retrieving x-ray results through the hospital computer system (CHCS). Suture removal, irrigations, surgical preps, and wound care using sterile techniques. Served as first surgical assistant to the orthopedic surgeon during major surgery and treatment of inpatients. Changed and applied dressings, holding incisions open, positioning limbs, removing sutures and administering medication specifically under direct instruction of the physician. Operate the Image Intensifier and Fluoroscope; apply cast and splints while observing sterile techniques. Lay out supplies and instruments necessary for the particular procedure. Ensure that all instruments and supplies have been sterilized before surgery. Hand instruments and supplies to physician during operative procedure both intuitively and by previous experience and by direction of the surgeon. Promptly and accurately execute the surgeon's directions. Administrative duties included scheduling appointments, screening medical records, ordering supplies, and maintaining equipment. Generating daily and monthly reports. Training and supervising new ortho techs, interns, and other personnel assigned to the orthopedic clinic in treatment room procedures, casting, and splinting techniques.

02/1991 -03/1994

Us Army, Ft. Ord, CA

Military Personnel Clerk

Provided support for a variety of automated systems including DEERS and the Family support programs. Coordinated actions, system problems, and updates with higher HQ. Recommended appropriate actions to resolve problems. Review and keep current on applicable regulatory guidelines for various entitlements and Family support programs. Applied rules and regulations pertaining to the Defense Enrollment Reporting System. Authority to approve or disapprove issuance of ID and privilege cards. Ensured requirements for classified materials were followed according to rules and regulations. Maintained control and suspense files. Assisted with providing or arranging community services as necessary making referrals to WIC, social work service, food locker, etc. Conducted interviews to obtain accurate and pertinent information to make assessment of presenting problems and to clarify entitlement and eligibility for assistance. Disseminate data in all available services for affected family members and military personnel.

Advised service and family members on procedures required to obtain medical and legal assistance, counseling programs available for various situations i.e. emotional support, spouse abuse, child neglect/abuse. Collect maintain and analyze data for planning and reporting purposes in accordance with governing program guidance and regulations. Advice

and guidance to other personnel on actions in areas of expertise. Participated in staff development programs. Maintained close working relationship with staff members attended professional administrative staff meetings and conferences. Maintain data on statistics for a variety of recurring and one time special reports.

Research Experience

Phase IV Open-Label, Multicenter, Randomized, Controlled Study to Evaluate Efficacy and Safety of PROCRIT in Subjects Undergoing Elective Major Abdominal or Pelvic Surgery

(1 year ongoing)

Phase II Study of Temozolomide and O6-Benzylguanine (O6-BG) in Patients With Temozolomide-Resistant Anaplastic Glioma

(1 year ongoing)

Phase II A Study to Assess the Impact of Once Per Cycle Correction and Maintenance Dosing of Darbepoetin Alfa in Subjects With Non-Myeloid Malignancies With Anemia Due to Chemotherapy

(2 years)

Protocol:

Phase III Randomized, Double-Blind, Multicenter, Placebo-Controlled Study of Adjuvant Lapatinib in Women With Early-Stage ErbB2 Overexpressing Breast Cancer

(1 year ongoing)

Protocol:

Phase III Efficacy of oral compound to prevent rejection after Cardiac Transplantation or Stent

Protocol:

Phase III Efficacy of oral compound to prevent rejection after Kidney Transplantation

Protocol:

Phase III Sickle Cell Disease Study

Protocol:

Phase III Gene Therapy

Protocol:

Phase III Parkinson Disease

Protocol:

Phase IV Injectable Osteoporosis Therapy Study

Protocol:

Phase III Diabetes Type II Study

Protocol:

Phase III Hypertension and Dyslipidemia in African Americans

Protocol:

Phase II Diabetes Type II Study

Protocol:

Phase III Diabetes Type II Study

Protocol:

Phase III Diabetes Type II Insulin Pump Study

Protocol:

Phase III Tele-Electrocardiography

Central ECG Device

Protocol:

Phase II MS daily injectable study for patients who failed treatment with Inteferon

Protocol:

Diabetes Type II Study

Protocol:

Phase IV Pediatrics Oncology Inpatient, Analgesic lollipop for break through pain (2 years)

Protocol:

AndroGel (Testosterone) treatment for Hypogonadal Men

Protocol:

Diabetes Type I and II Study

Protocol:

Phase IV Topical Ointment to Treat Acne

Protocol:

The Hypopituitary Control and Complications Study, Human Growth Hormone

Protocol:

The Genetics and Neuroendocrinology of Short Stature International Study Pediatrics, HGH

Protocol:

Erectile Dysfunction

Protocol:

Diabetes Type II Study

Protocol:

Phase III Oral Compound to treat CHF

Protocol:

Diabetes Type II Study

Protocol:

Phase IIB, Multicenter, Randomized, Double Blind Placebo Control Trail to Assess the Safety and Efficacy of MPR-7869 in delaying the systemic progression of Prostate Cancer in patients with Intermediate to High Risk of Recurrence with rising PSA levels after Prostatectomy and Radiotherapy or Radiotherapy Alone

( 1 year)

Protocol:

Phase II, Randomized, Double Blind, Controlled Study to Evaluate the Safety and Efficacy of PROSTVAC-VF/TRICOM in Combination with GM-CSF in Patients with Androgen-Independent Adenocarcinoma of the Prostate

(16 months)

Protocol:

Phase III randomized, double blind study of DFMO vs Placebo in low grade bladder cancer

(2 years)

Protocol:

Phase IV National Cooperative Somatropin Surveillance (NCSS) of Nutropin AQ and Nutropin Replacement Therapy in adults with Growth Hormone Deficiency.

Protocol:

Phase IV (NCGS) Post Marketing Surveillance Program for Nutropin Depot [somatropin (rDNA origin) for injectable suspension], Nutropin AQ [somatrem (rDNA origin) for injection], Nutropin [somatrem (rDNA origin) for injection] and Protropin [somatrem for injection]. Pediatrics. Human Growth Hormone

Protocol:

Phase III Invitro Medical device for Rapid HSV

Protocol:

Phase III Invitro Medical Device for Rapid GC/Chlamydia

Protocol:

Phase II Bordella among military trainees

Protocol:

Phase I Mycoplasma Pneumoniae among active duty military

Protocol:

Phase I Medical device for rapid influenza results

Protocol:

Phase IV Topical Ointment to Treat Genital Warts

Protocol:

Phase I Meningitis Disease/Vaccine among Active Duty Military Trainees

Protocol:

Phase I Respiratory (Adenovirus) illness among military trainees

Protocol:

Phase II Respiratory Syncytial Virus (RSV) among military trainees

Protocol:

Phase I Pneumococcal Vaccine among Active Duty Military Personnel

Protocol:

Phase I Gulf War Syndrome among active duty military



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