Project Manager Medical

KAAMILYA CLYNE

*** ******** ******* **. **. Johns Fl 32259

Home 904-***-****

E-mail abm4y9@r.postjobfree.com

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EDUCATION

Bowie State University, Bowie, MD

2007-2010

Bachelors of Science, Psychology

GPA 3.8

Everest Institute, Silver Spring, MD

Graduated June 2006

GPA 4.0

Winston-Salem State University, Winston-Salem, NC

1996-1999

NUR/PSY

EXPERIENCE

Clinical Research Associate/In-house CRA

Monitoring Force USA, October 2008 to present

Jacksonville, FL 32216

. Review and process regulatory documentation, ensure the execution of

clinical trials in a timely, efficient manner, working within

established timelines and budgets.

. Collect and maintain & reconcile site files, trial master files and

study documentation. Develop status reports, SOP revisions and

document quality control.

. Track clinical trial supplies, patient recruitment activities, and

Serious Adverse Events, review Case Report Forms for accuracy and

completeness and conduct query resolution.

. Performed Co-monitoring visits at clinical investigative sites with

regional associates to ensure adherence to procedures, protocols and

project plans in accordance with FDA regulations.

o Perform monitoring of CRFs, source documents, and review consent

process

o Perform drug accountability

o Perform detailed regulatory binder review

o Create monitoring clarification logs to ensure protocol is being

followed by site

. Perform close out visits.

. Organize and maintain project working files and track critical

documents. Transmit and reconcile all essential documentation for MF

to maintain integrity of archival files.

. Oversee the conduct of assigned clinical studies including acting as

liaison to regional associates, ensuring the quality and integrity of

data.

. Process and forwarded CRF's to data management

. Assist in house Clinical Research Associates, Project Manager, and CEO

in routine tasks

. Participate in clinical protocol writing, case report form design

Submission of Regulatory documents

. Source document development and completion

. Collect and review study related regulatory and financial documents.

Distribute copies to appropriate departments.

. Implement mass mailing on behalf of sponsors

. Prepare IRB submissions and continuing reviews reports

. Responsible for tracking all documents received in-house

Clinical Research Coordinator, July 2007 to June 2008

Walter Reed Army Medical Center, Washington, DC

Employer: True Research Foundation San Antonio, TX 78217

Center for Liver Disease

. Coordinate Hepatitis Clinical Trails

. Maintain accurate CRF's

. Meet with sponsor's representatives or monitors to discuss conduct of

the study and review data

. Submit IND safety reports

. Input information into electronic data capture systems

. Prepare regulatory documentation for submission and review of

protocols

. Prepare manuscript submission of completed protocols

. Processed, packaged and shipped laboratory specimens

. Experience in working with a Local IRB.

Clinical Research Coordinator

MD Medical Research, May 2006-July 2007

Oxon Hill, MD

. Successfully coordinated first study after three months of employment,

and doubled enrollment in two months

. Planned, organized, and conducted community health fair in efforts to

recruit potential

Subjects

. Obtained, processed, packaged and shipped laboratory specimens

. Recruited and screened potential study subjects according to protocols

inclusion/exclusion criteria

. Created and maintained organizational tools to conduct studies

accurately and in compliance with GCP guidelines.

. Dispensed study medication, verify drug accountability and monitor

drug storage.

. Perform study initiation and termination activities.

. Retrieves and reports all adverse events to PI, sponsor and serious

adverse events

. Ensure proper written consent form each study subject prior to

participation in the study.

. Prepare for monitoring visits by organizing all clinical sources of

patient date pertinent to the clinical trials.

. Strong understanding of FDA, GCP and ICH guidelines.

. Coordinated Phase I,II &III trails

. Coordinates trails in the areas of Hypertension, Hyperlipidemia,

Diabetes, Weight-loss, and Osteoporosis

Certifications

Registered Medical Assistant, CPR, OSHA/HIPPA, Phlebotomy, Arena Healthy

Lifestyle Diet and Exercise Counselor.

EDC SYSTEMS: Inform 4.1&4.5, Phase Forward, Medidata, Trail Recorder,

ClinPro, INC., Macro. CTMS

Summary of Skills

Phlebotomy, Injections, Vitals, ECG 12-lead, Holter Monitoring, CPR,

Processing and Packaging biological substances, filing, strep test,

pregnancy tests, urinalysis, scheduling appointments, Immunizations,

Medical Terminology, ICD-9/CPT coding and billing, Medical Transcription,

Microsoft Office Suite, Medi soft.

Honors

Psi Chi National Honor Society in Psychology

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