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Lead CRA

Location:
Wilmington , North Carolina, 28412, United States
Posted:
March 14, 2011

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CURRICULUM VITAE

NAME: Sandra Allen-Paul

LOCATION: Wilmington, NC

CONTACT NUMBER: 910-***-****

CURRENT JOB TITLE: Clinical Operations Lead

SUMMARY OF EXPERIENCE:

Seventeen years experience in clinical trials monitoring and management, including implementation of study protocols with special emphasis on compliance with FDA regulations and on-site data management. Therapeutic experience include: GI (DU and GU), cardiovascular, Erectile Dysfunction, Bronchitis, Sinusitis, RDV, Overactive bladder, Obesity, Dysmenorrhea, IBS-Constipation studies.

Four years experience in Marketing and Sales Representative. Focus was in Chronic Cardiovascular Care and Antibiotic therapy and training.

THERAPEUTIC AREA EXPERTISE:

Significant experience in and GI, GU, Anti-Infective, Respiratory and Cardiovascular.

Indication Phase # Patients # Sites Countries Services Involved

Gastric Ulcer (GU and DU) III 700 65 US Clinical Quality Assurance Monitor and Monitoring

Neonatal RVS II 100 12 US Full Service

Cardiovascular Stroke Preventions and Treatment II 160 20 US Full Service

Erectile Dysfunction IV 500 40 USA Full Service

Acute Exacerbation of Chronic Bronchitis and Sinusitis IV 400 50 US Project Management, Monitoring and Data Management

Over Active Bladder III 300 35 US Project Management, Monitoring, QC and Data Management

IBS-Constipation IV 500 30 US Full Service

COPD IIb 130 45 Project Management, Monitoring, Medical Monitoring and Data Management

PROFESSIONAL EXPERIENCE:

Operation Leader, PAREXEL International, RTP Decentralized, Wilmington, NC

Apr 2010 - Present

• Responsible for coordinating functional team members and their activities across relevant geographies, liaising with project management and the sponsor to ensure that the Global Research Operations deliverables (timeline, quality, productivity) are met.

• The Lead has overall accountability for the execution of the operational strategy and plan within Global Research Operations including development of project tools, using of basic analytical tools and assessing financial impact of decisions, implementing and initiating process improvement, responding to the needs of internal and external client, decision making and communicating flow of action, encouraging communication with other functional leads, and prioritization of key issues.

Lead Clinical Research Associate, ZeeCRO (formally AAIPharma), Cary, NC, Home based - Dec-2007- Apr 2010

• Mentored junior clinical team members

• Communicated with Sponsor regarding clinical issues, line manager of CRA’s, clinical liaison for sites, clinical deliverables to Client.

• Reviewed of Monitoring Reports

• Identified potential investigators with Feasibility and Study Start Up Team

• CRA training, applicable clinical areas

• Managed study vendors. i.e. Kronos IVRS , Inform, Local Lab.

• Generated the monthly newsletters

Clinical Research Associate II, Essential Group, Chicago, IL,

Feb 2006- Dec 2007

• Conducted Pre-Study, Initiation, Interim Monitoring, and Close Out visits according to applicable Standard Operation Procedures and FDA guidelines.

• Managed and maintain initial contact with assigned sites

• Assisted with the review of essential regulatory documents

• Assisted in identifying and evaluating potential investigators

• Conducted and documented site staff training

• Monitored /resolved Case Report Form discrepancies,

• Performed drug accountability and reconciliation

Assistant Project Manager/Clinical Team Manager, PPD Inc., Wilmington, NC

Jan 2004- Feb2006

• Direct assist to the Project Manager

• Performed study timeline tracking

• Managed day to day clinical team activities

• Reviewed and tracked monitoring reports

• Conducted clinical team training and maintained training records

• Reviewed visit timelines

• Conducted CRA team meetings

• Generated and maintained updates to Study Procedure manual and Pharmacy Manual

Chronic Care Sales Representative, Bayer Corporation, West Haven, Conn.

Dec 1999- Jan 2004

• Cardiovascular/ Chronic Care Representative

• Promoted Sales in assigned territory

• Maintained and tracked sales and trends

• Completed extensive training in hypercholesterolemia and antibiotics

• Organized and conducted training with are Physicians regarding new indications and new doses

• Emergency Room, Surgical and Hospital Sales forces for IV Antibiotics

Project Team CRA, PPD Inc., Wilmington, NC

Aug 1991 – Dec 1999

• PTCRA team managed clinical research centers

• Assisted in the completion of SIV, IMV and COV

• Maintained and prepare regulatory documents

• Generated Case Report Form guidelines

• Assisted Data Management in CRF Clinical QC review

• Tracked and resolved manual queries after CRF retrieval

Regulatory Specialist/Quality Assurance Manager, PPD Inc. Wilmington, NC

Dec 1989 – Aug 1991

• Establish and maintained in-house regulatory files

• Conducted in-house and on-site file audits

• Tracked FDA audit reviews and site trends

• Completed contracted percentage CRF data review

• Tracked query generation and resolution

Medical Technologist II: Pitt County Medical Center, Greenville, NC

April 1986- Nov 1989

• Performed Special Chemistry including (GC, Cardiac Isoenzymes Electrophoresis, Cystic Fibrosis Sweat Testing, A1C testing, Immunoassay HIV)

• Pharmacology Lab Specialist Tasks (Toxicology Screening, Antipsychotic management, Antibiotic Peaks and Troughs)

• Cardiovascular Surgery STAT Lab Tech (CABG, Heart Transplant, Valve Replacements, Stat Blood Gas, Heparin Reversal)

• Neonatal Lab Tech, (STAT H/H, O2 Sats)

EDUCATION:

West Tennessee Jackson State Community College, Jackson, TN, Biology/Chemistry, 1979-1980

University of Tennessee at Martin, Animal Science/Chemistry/Biology, 1980-1983

University of Tennessee Center for Health Science, Memphis, TN. BSMT 1985

LANGUAGE SKILLS:

English: currently learning French.

ACADEMIC APPOINTMENTS:

None

ACADEMIC APPOINTMENTS:

Association of Clinical Research Professionals since 1998

PUBLICATIONS:

None



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