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Senior CRA

Marietta, Georgia, 30067, United States
March 07, 2011

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**** * ****** **** ****, Marietta, GA 30067



- Shaw University, Raleigh, NC, B.A., Sociology, 1986


Experience in clinical trial coordination, including initiating, administering and maintaining protocols with emphasis on FDA compliance. Therapeutic areas of experience include Cardiology (Hypertension), Infectious Disease (Prostatitis and UTI), Diabetes, Obesity, Respiratory, Nephritis, Irritable Bowel Syndrome, COPD, GERD and Pain Management (Osteo-Arthritis). Phases include II, III and IV.


Chiropractic Assistant, Hewett McNeil Family Chiropractic, Douglasville, GA, June 2010-Present

Greeting patients give them appropriate medical history and insurance forms to complete, as well as answer phones and schedule appointments. Record patients' medical and treatment information, and receive payment or health insurance information for billing purposes. Maintain patient records, filing and ordering supplies for the practice. Prepare exam and treatment. Escort patients to exam areas, review paperwork to ensure accuracy and completion, explain any required procedures to prepare the patient before the chiropractor's exam and treatment.

Sr. Clinical Research Associate, Novo Nordisk Group, Inc, Princeton, NJ, Oct 2009- Dec 2009 (SWAT Contract Position)

Primary conducts site selection visits for diabetes trials for high enrolling sites that primary CRA is unable to attend. Responsible for performing study site management activities regarding the implantation, monitoring, and summarization of clinical trials to ensure adherence to protocols, Good Clinical Practice (GCP), ICH Guidelines, federal regulations and SOPs. Develop and maintain collaborative Working relationships with clinical investigative sites. Serve as primary contact for clinical investigative Sites on multi-therapeutic trials. Contributed to the site and investigator selection process. Performs and facilities study start-up activities. Ensure site understands protocol and adhere to ICH-GCP guidelines, Local regulatory requirements and SOPs. Conducts on-site visits and on-site/off site monitoring activities to ensure clinical sites are complying with study protocols, FDA regulations, company SOPs, ICH Guidelines and GCPs including confirming patient eligibility, protocol compliance, tracked Patient

Enrollment, review informed consent forms, maintain project and visit timelines, ensuring accurate transcription of data from source documentation. Writes and submits timely and accurate monitoring reports. Perform site level drug accountability, reconciliation and destruction activities.

Sr. Clinical Research Associate, Kendle International, Cincinnati, OH, Aug 2008-Jul 2009

Completed project activities associated with monitoring functions of Phase II-IV clinical research studies while continuing to develop knowledge of the drug development process. Adhered to Good Clinical Practices and relevant regulations. Provided clinical and technical support for CRA I, CRA II and administrative staff. Managed study site activities to ensure the integrity of clinical data in adherence to all applicable regulatory guidelines and SOP.

Clinical Research Associate II, PAREXEL International Corporation, RTP, NC Aug 2007- Apr 2008

Responsibilities include: overseeing the conduct of a clinical trial to include the quality and integrity of data and safety and efficacy of the drug. Exercised responsibility for project activities related to monitoring function and interface with clinical investigators and site personnel in order to carry out this responsibility. Performs all types of visits

Clinical Research Associate II, INC/Advanced Biologics May 2004-Jun 2007

Monitored investigational drug studies in Phases III, IIIB, and IV, including: Source

Document review in comparison to CRF data, CRF review/retrieval and data corrections, drug accountability, maintenance of on-site investigator files, IRB documentation, local laboratory documentation, maintenance of investigational supplies. Handled safety and efficacy issues, including, but not limited to: Serious adverse event reports, adverse event trends and treatment failures. Contributed to the selection of study investigators. Conducts site contacts, including: Prestudy visits, initiation visits, monitoring visits, telephone contacts and study completion visits. Reviews consent process for each subject (Informed Consent Form and source documentation).

Claims Analyst, Continental Life Insurance Company, Brentwood, TN, Feb 2003-May 2004

Reviewed medical records on policies with in the two-year contestable period. Reviewed records for pre-existing conditions to determine if policyholder is eligible for coverage based on the answer to questions on the application. Denied claims and rescinded polices based on medical records. Communicated with agents, policyholders, doctors, lawyers and the legal department etc. Made final decision regarding payment of claims.

Clinical Research Associate II, ICON Clinical Research, Brentwood, TN Jun 2002- Jan 2003

Managed assigned investigational study sites and performed on-site quality reviews of case report form data. Conducted routine monitoring visits to ensure investigator and staff are in compliance with protocol, FDA and ICH regulations, GCPs and pertinent SOPs. Verified case report form information against source documents and reconcile data entry queries. Reviewed site study files for completeness and up to date information, which included IRB related documents. Ensured informed consent was administered properly and advise site of any execution issues. Performed drug accountability and reconciled counts with CRF, source data and dispensing logs. Oversaw and evaluated subject enrollment, and compiled and reviewed patients’ status Performed site initiation and closure visits

Clinical Support Coordinator, GlaxoSmithKline, RTP, NC- Oct 2001- Jun 2002

Provided matrix clinical support to conduct of studies. Participated in developing study team process. Coordinated dissemination of protocols and study materials, internally and externally. Designed, developed, implemented and/or maintained study related documentation. Ordered, monitored and tracked study supplies, including study medication. Tracked Serious Adverse Events and IND Safety Reports as required. Liaised with sites, CRO, monitors, and vendor personnel as needed to resolve appropriate study-related issues. Mentored CSC and other study support personnel as needed. Primary contact for CRO for files, printing/distribution of study materials, and allocation of Investigator, Site and Treatment Number information. Assisted with maintenance of invoice tracking and payment process for study specific budget, including grant requests. Assisted with investigator meetings and materials required for study reference manual. Traveled to participate in meetings. Maintained investigator and patient database for study specific tracking. Assisted with compilation and review of FDA documents for regulatory submission. Filed and archived specific study project and investigator files or coordinate process with CRO. Liaised with Monitors and/or site to obtain outstanding regulatory documents.

Clinical Research Associate, PPD, RTP, NC, Feb 1999-Sep 2001

Monitored and coordinated all aspects of the clerical monitoring process for the TCC Dept. according to PPD SOPS and Federal Regulations. Conducted site selection and site initiation visits. Independently monitored assigned clinical sites. Assured study site adherence to protocol, company policies and FDA requirements. Identified and reported adverse experiences. Reviewed Case Report Forms (CRFs) according to Standard Operating Procedures (SOPs) and transmitted completed CRFs to the company. Coordinated the supply of study materials needed for timely implementation and completion of assigned studies. Authored site visits report and related site correspondence according to Companies SOPs.

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