Medical Assistant Clinical Research

Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

*

*** *. **** ******** **** #2055

N. Las Vegas, NV 89031

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

CLINICAL RESEARCH SUMMARY

Certified Clinical Research Professional (CCRP), with 18 years of experience in clinical research. Titles to include, Clinical Research Coordinator, Research Site Director/Manager, Data Management, Laboratory Manager, Quality Control Coordinator and Regulatory Coordinator. WORK HISTORY

2013-Present UNLV/Medicine (Formerly University of Nevada, School of Medicine) Department of Surgery

Division of Colorectal & Surgical Oncology

Clinical Research Coordinator

Developed Clinical Research division within the department of surgery

Established research site start up procedures including development of the departments laboratory for blood draws and CLIA waved testing

Recruited Industry Sponsored Clinical Trials. (Drugs and Devices)

Coordinated Investigator Initiated Trials

Performed all study start up activities, including budget negotiations and contract reviews

Responsible for Institutional Review Boards (Central and Local) and Office of Sponsored Projects submissions

Maintained local hospital credentialing to conduct enrollment/randomization visits in the operating room and subsequent in-patient follow up visits

Dispensed investigational drugs and/or devices and maintained accountability logs

Conducted patient visits to include screening, consenting, medical and medication histories, vital signs, lad draws, processing and shipping, data clarifications, AE’s and SAE’s documentation

Scheduled and attended Interim Monitoring Visits, Site Qualification Visits, Site Initiation Visits, Close Out Visits and attended Investigator Meetings 2012-2013 Comprehensive Cancer Center

Phase I and II Research

Data Management Coordinator

Scheduled and attended Interim Monitoring Visits, Site Qualification Visits, Site Initiation Visits, Close Out Visits and attended Investigator Meeting

Used various electronic data capture systems, including Inform, Oracle, RAVE, and ClinTrack

Query resolution

Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

2

2010-2011 CMF Clinical Trials/US Medical Research Center (Per Diem) Independent Contractor

Quality Assurance/Business Developer

Intermittent site visits to review research data for completeness and accuracy

Conducted staff training

Regulatory documents review

Investigational product accountability

Inclusion/Exclusion criteria’s

Conducted review on source documents, case report form completions

Reviewed query’s and query resolutions

Verified monitoring editing notes to assure site had resolved any pending action items

2007-20013 Office of Ted Thorp MD.

Family Medicine

Site Director/Study Coordinator

Founder of Research Site

Developed Clinical Research division within the clinic

Established research site start up procedures including development of the departments laboratory for blood draws and CLIA waved testing

Recruited Industry Sponsored Clinical Trials.

Performed all study start up activities, including budget negotiations and contract reviews

Responsible for IRB Submissions

Dispensed investigational drugs and maintained accountability logs

Conducted patient visits to include screening, consenting, medical and medication histories, vital signs, lad draws, processing and shipping, data clarifications, AE’s and SAE’s documentation

Scheduled and attended Interim Monitoring Visits, Site Qualification Visits, Site Initiation Visits, Close Out Visits and attended Investigator Meetings

Patient Recruitment

2005-2007 VA Healthcare of Southern Nevada

Southwest Clinic

Clinical Research Coordinator

Performed study start up activities

Responsible for IRB Submissions

Dispensed investigational drugs and maintained accountability logs

Conducted patient visits to include screening, consenting, medical and medication histories, vital signs, lad draws, processing and shipping, data clarifications, AE’s and SAE’s documentation

Scheduled and attended Interim Monitoring Visits, Site Qualification Visits, Site Initiation Visits, Close Out Visits and attended Investigator Meetings

Patient Recruitment

Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

3

2004-2004 Oasis Research Center

Stand Alone Research Center

Site Manager/Clinical Research Coordinator

Established research site start up procedures including development of the departments laboratory for blood draws and CLIA waved testing

Performed all study start up activities, including budget negotiations and contract reviews

Responsible for IRB Submissions

Dispensed investigational drugs and maintained accountability logs

Conducted patient visits to include screening, consenting, medical and medication histories, vital signs, lad draws, processing and shipping, data clarifications, AE’s and SAE’s documentation

Scheduled and attended Interim Monitoring Visits, Site Qualification Visits, Site Initiation Visits, Close Out Visits and attended Investigator Meetings

Subject Recruitment

Managed and Trained Staff

2002-2004 Clinical Research Solutions

Sheldon J. Freedman, MD

Urology

Clinical Research Coordinator

Responsible for IRB Submissions

Dispensed investigational drugs and maintained accountability logs

Conducted patient visits to include screening, consenting, medical and medication histories, vital signs, lad draws, processing and shipping, data clarifications, AE’s and SAE’s documentation

Conducted hospital in patient study visits

Scheduled and attended Interim Monitoring Visits, Site Qualification Visits, Site Initiation Visits, Close Out Visits and attended Investigator Meetings

Subject Recruitment

2000-2002 Comprehensive Neurosciences (Formerly ICSL, Clinical Studies, LTD) Clinical Research Coordinator

Laboratory Supervisor

Recruitment Coordinator

Research Assistant

Performed all study start up activities

Responsible for IRB Submissions

Dispensed investigational drugs and maintained accountability logs

Conducted patient visits to include screening, consenting, medical and medication histories, vital signs, lad draws, processing and shipping, data clarifications, AE’s and SAE’s documentation

Scheduled and attended Interim Monitoring Visits, Site Qualification Visits, Site Initiation Visits, Close Out Visits and attended Investigator Meetings

Subject Recruitment

Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

4

Additional duties/accountabilities

EKG’s

Spirometry

24 hour holter monitor

Appointment scheduling

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Office and Medical supply ordering

EDUCATION

National Education Center (Medical Assistant Program) Los Angeles, CA

West Las Angeles Jr. College

Culver City, CA

Los Angeles High School

Los Angeles, CA

TRAINING/CERTIFICATES

Clinical Research Professional (Certification)

Dangerous Goods and Shipping Training/Certificate

CITI (Biomedical Research Training/Certificate)

CITI (Good Clinical Practice Training/Certificate) CPR Certification

Laboratory Assistant Certificate

CLINICAL TRIAL EXPERIENCE

Prospective, multicenter, multidisciplinary, controlled clinical Investigation evaluating the safety and efficacy of Per Clot Polysaccharide Hemostatic System. The Clot Investigation A multicenter post-market clinical follow-up of the Medrobotics Flex Robotic system and Flex Rectoscope used for assessing and visualizing the anus, rectum and distal colon during transanal procedures

A Randomized Study to Assess the Predictive Validity of da Vinci Skills Simulator Transferring surgical skills obtain through virtual reality simulation to the operating room: Does video instruction help facilitate learning? (Colorectal Surgery Arm) Pilot study for the assessment of fluorescent markers for ureter identification (In-patient) A Phase III, randomized, placebo controlled study to investigate the efficacy and safety of the XaraColl XXXX Implant (XXX mg after open Laparotomy Hernioplasty (In-patient) A randomized, controlled, parallel, multi-center study assessing perfusion outcomes with PINPOINT Near Infrared Fluorescence imaging in low anterior resections. (In-patient) Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

5

Signaling pathways and cytokine activity within the breast carcinoma, metastatic lymph node track. (In-patient)

Prognostic impact of sentinel node biopsy for colon cancer using near infrared fluorescent imaging. (In-patient)

Efficacy and Safety of the Ligation of the Intersophincteric Fistula Tract versus Endorectal Advancement Flap. (In-patient)

An open, 5-year registry study to track clinical application of Decision Dx-melanoma gene Expression profile assay results and associated patient outcomes. A multi-center database of Hepato-Pancreato-Biliary and Liver metastatic disease registry study. A prospective, single blind, randomized, Phase III study to evaluate the safety and efficacy of XXXX Grifols (FS Grifols) as an adjunct to hemostasis during Parenchymous Tissue Open Surgeries. (In-patient)

A randomized, open-label, parallel group, multi-center to determine the efficacy and safety of XXXX as compared with XXXX in subjects with Type II Diabetes mellitus. A randomized, double-blind, active controlled, parallel group, multi-center study to determine the efficacy and safety of XXXX as compared with XXXX in subjects with Type II Diabetes Mellitus with Renal Impairment.

A randomized, double-blind, placebo controlled, parallel group multi-center study to determine the efficacy and safety of XXXX when used in combination with metformin alone compared with metformin plus XXXX in subjects with type II diabetes mellitus. A randomized, open label, parallel group, multi-center study to determine the efficacy and long term safety of XXXX compared with insulin in subjects with type II diabetes mellitus A randomized, double-blind, placebo controlled, parallel group, multi-center study to determine the efficacy and safety of XXXX when used in combination with a thiazolidinedione with or without metformin in subjects with type II diabetes mellitus A randomized, double-blind, placebo controlled, parallel group, multi-center study to determine the efficacy and safety of two doses levels of XXXX compared with placebo in subjects with type II diabetes mellitus

A Phase III, multi center, randomized, double blind, placebo controlled study to evaluate the efficacy and safety of Intramuscular XXXX in subjects with uncomplicated acute Influenza. A phase III, 53 weeks’ study on analgesic efficacy and safety of XXXX xx in subjects with OA of the knee.

Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

6

A randomized, double blind, placebo and XXXX immediate release (IR) - controlled study of XXXX for the treatment of acute pain caused by vertebral compression fractures associated with osteoporosis.

A randomized, controlled trial of DuraGen Plus Adhesion Barrier Matrix to minimize adhesions following lumbar disectomy. (In-patient)

A double-blind, placebo controlled study to compare the safety and efficacy of xxxx and xxxx in patients with obesity.

A phase II, multi center, randomized, double-blind, placebo controlled, parallel-arm, dose comparison study of the efficacy and safety of oral 25mg, 50mg, 75mg xxxx and placebo in the treatment of patients with Chronic Obstructive Pulmonary Disease. A phase II, parallel group, stratified, randomized, double-blind, placebo controlled trial to investigate the efficacy and safety of three different doses of sustained release xxxx in subjects with overactive bladder showing either involuntary detrusor contractions or normal findings during the baseline urodynamic assessment.

A two phase extension trial of xxxx to investigate the safety and tolerability of sustained release xxxx in subjects with overactive bladder. A double-blind phase followed by an open label extension phase.

A double-blind, placebo controlled study to evaluate the efficacy of xxxx in the early treatment of headache in subjects with migraines.

An open label, parallel design, twelve month, phase III trial to demonstrate the efficacy xxxx xxxx in association with intermittent pneumatic compression vs intermittent pneumatic compression used alone for the prevention of venous thromboembolic events in patients at increased risk undergoing major abdominal surgery. Open, randomized, phase II clinical trial to compare the immunogenicity and safety of a booster dose of GSK biological xxxx-xxxx vaccine (xxxx xxxx) co-administered with a booster dose of Merck and company’s x-x-x to that of separate injections of GSK’s biological xxx x vaccine

(xxxx xxxx), Aventis Pasteur’s xxx vaccine (xxxx) and x-x-x administered as booster doses to healthy children 4 to 6 years of age.

A randomized, 26 week, double-blind, placebo controlled trial to evaluate the safety and efficacy of xxxx in the treatment of dementia secondary to cerebrovascular disease. Insulin xxxx (DNA origin injection) (xxxx) vs xxxx (xxxx) as add on therapy in patients failing monotherapy with xxxx or xxxx (xxxx). A randomized, open, parallel study. A double-blind, multi center, randomized, placebo controlled, parallel group study of the effects of xxxx on safety and efficacy in patients with mild to moderate hypertension. Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

7

A phase II study on analgesic, efficacy, safety and tolerability of xxxx. A six week, randomized, double blind, placebo controlled, dose finding, multicenter study comparing xxxx with xxxx in subjects with osteoarthritis of the knee.

A 12 week, randomized, double blind, active controlled, multi center, parallel group study to investigate the gastrointestinal safety of xxxx mg bid compared to xxxx mg bid in patients who have osteoarthritis of the knee or hip and are taking low dose enteric coated aspirin. A randomized, double blind, placebo controlled study to evaluate the safety and efficacy of three doses of synthetic 10-componet conjugated estrogens xxxx xx mg and xx mg modified release tablets compared with placebo in hysterectomized, post-menopausal women for the prevention of osteoporosis.

A multicenter, double blind, placebo controlled, randomized study to determine efficacy in the relief of hot flushes in women receiving oral xxxx xxxx tablets. A multicenter, long term, follow up study of the duration of sreoprotection after hepatitis B vaccination and an open label study of the efficacy and safety of a single dose of xxxx in subjects with low anti HB’s values.

A randomized comparator, controlled, double blind study of liver safety of xxxx vs xxxx with xxxx and insulin as part of step therapy in subjects with type II (non-insulin dependent) diabetes. A randomized, double blind, safety and efficacy pilot study of xxxx vs xxxx first line anti- hypertensive therapy in patients with type II diabetes mellitus and hypertension. A study to assess long term antiviral activity, safety, including serum lipids and tolerability of xxxx in combination with xxxx (d4t) and xxxx (3tc) in subjects previously treated with xxxx or xxxx.

A multicenter, randomized, double blind, parallel group clinical evaluation of oral xxx sodium tablets xx mg xx mg and xx mg xxxx in combination with xxxx for the 26 weeks duration in subjects with type II diabetes mellitus who are inadequately controlled on a maximum dose of xxxx.

XXXX Cardiovascular treatment assessment versus XXXX. (Octave study) A double blind, randomized study to evaluate the effects of fixed combination xxxx/xxxx therapy in subjects with type Ii diabetes mellitus who have inadequate glycemic control on half maximum to maximum of the labeled doses of xxxx monotherapy. A multicenter, randomized, double blind clinical trial study to evaluate the efficacy and safety of xxxx tablets to xxxx plus xxxx therapy in patients with type II diabetes mellitus who have inadequate glycemic control with xxxx monotherapy. Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

8

A phase III, parallel, randomized, multicenter, open label clinical study to evaluate the efficacy and safety of xxxx extended oral contraceptive therapy- 84-day active cycle. A randomized, multi center, double blind, parallel group clinical study to compare the effects of xxxx (xxxx) vs placebo as initial oral therapy in subjects with type II diabetes mellitus who fail to achieve adequate glycemic control with diet and exercise alone. A double blind, placebo controlled, parallel group comparison study to evaluate the role of the addition of xxxx to NIDDM patients not responding to maximum dose of xxxx and xxxx. A phase III contraception study of xxxx xxxx xxxx subcutaneous injection (xxxx sc) in women of childbearing potential in the America’s (including a bone mineral density) sub study comparing the effects of xxxx sc and xxxx im also, including a return to ovulation sub study. A phase III study of xxxx xxxx xxxx subcutaneous injection ccc in women with endometriosis in the US and Canada.

A multi-center randomized, double blind, active controlled study to compare the effects of 24 weeks treatment with xxxx mg bid to xxxx mg qd in drug naïve patients with Type II diabetes. A multi-center, double blind, randomized, parallel group study to compare the effects of 24 weeks treatment with xxxx to placebo as add on therapy in patients with Type II Diabetes treated with insulin.

A multi-center, randomized, double blind study to compare the effects of 24-week treatment with XXXX xx mg QD, XXXX xx mg BID or XXXX mg QD to placebo in drug naïve patients with Type II Diabetes.

A six week, randomized, double blind, placebo controlled, multi-center study to assess the efficacy and safety of oral xxxx to placebo in female patients with dyspepsia. A 24 week, randomized, double blind, parallel group, multi-center, active controlled xxxx study to evaluate the efficacy, safety and tolerability of xxxx therapy when administered to patients with Type II Diabetes.

Trial to reduce cardiovascular events in patients with Type II Diabetes, Anemia and Chronic Kidney Disease with xxxx therapy.

A multi-center, double blind, randomized, parallel group study to compare the effects of 24 weeks treatment with XXXX XX mg QD or BID to placebo as add on therapy to XXXX xx mg QD in patients with Type II Diabetes inadequately controlled with thiazolidinediones monotherapy.

A multi-center, double blind, randomized, parallel group study to compare the effects of 24 weeks treatment with XXXX mg QD or BID to placebo as add on therapy to XXXX in patients with Type II Diabetes inadequately controlled with sulfonylurea monotherapy. Curriculum Vitae

Sheila Moore, MA, CRC, CCRP

9

A multi-center, randomized, double blind, active controlled study to compare the effects of 24 weeks treatment with combination therapy of XXXX and XXXX to XXXX monotherapy in drug naïve patients with Type II Diabetes.

The Study of Heart and Renal Protection. Ongoing XXXX alone and in combination with XXXX. Global end point trial.

A large, simple, randomized trial of an angiotensin II receptor antagonist XXXX and an ace inhibitor XXXX in patients at high risk for cardiovascular events. And including a parallel study. (XXXX randomizes assessment study in ace intolerant subjects with cardiovascular disease).

A double blind, placebo controlled study to determine the safety and effectiveness of the study drug XXXX in patients with Type II Diabetes and Microalbuminuria. Signaling pathways and cytokine activity within the breast carcinoma metastatic lymph node track and melanoma metastatic lymph node track: An assay of xxxxx and xxxx/xxxx in ductal lymphatic epithelium.

MEDICAL ASSISTANT EXPERIENCE (Front and Back Office) 06/99-09/99 Exodus Medical Group

Internal Medicine and Infectious Disease

Back Office Medical Assistant

Marina Del Rey, CA

06/98-05/99 Comprehensive Primary Care

Internal Medicine

Back Office Medical Assistant

Henderson, NV

06/96-11/97 Santa Monica Internal Medicine

Internal Medicine

Back/Front Office Medical Assistant

Vital signs, phlebotomy, specimen processing, urinalysis, urine pregnancy test, throat and urine cultures, EKG's, treadmills, 24 hour holter monitors, PFT's, injections, minor office surgery assisting, pap set ups. IV set ups, pharmacy call, prescription refills, medical terminology, appointments, phones, referrals, prior authorizations, office and medical supply ordering. Honors

Medical Assisting Program; Honor Roll- All modules (Academic & Attendance) Hobbies and Interest

Creative writing, stage and screenplays, roller skating and swimming

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