acd9ts@r.postjobfree.com

Website: www.backupskills.com +770-***-****/3-624******

PROFESSIONAL SUMMARY

Multi-lingual (English – French – Spanish) pharmaceutical associate involved in active global clinical

trials utilizing ability to effectively partner with Senior Project Managers on governance of Start-up

studies, Sites Initiation, monitoring, and Close out visits. Oversee submissions and publications to

Central Institutional Review Boards and completion of routine file reviews, GCP, GMP, GLP, GDP and

SOP compliance. Therapeutic areas: Neurology with indication on Alzheimer phase III, Bipolar

Disorder phase II, Cardiac, and Oncology Phase I. Strong knowledge of validation of IT systems, data

privacy and review of sites visits for payments to Investigators. Provide excellent customer service to

stakeholders (Sponsors, CRO, and vendors). Key strengths include:

Business Development

Regulatory Compliance

Record Management Specialist

Archivist for Global Trials Project Management

Sponsor/ CRO Relations Sales/Marketing

Biotech Services – ISO 9000 Clinical ResearchAssociate

Regulatory Start up QA QC Research and Analyst

EMPLOYMENT HISTORY

QUINTILES TRANSNATIONAL – Smyrna, GA 2011-2014

CLINICAL STUDY SPECIALIST

• Monitored global clinical trials.(Submissions to Regulatory -84 sites well coordinated)

• Provided direct personnel management and Sites payments.

• Maintained an overview of the active clinical trials and their assigned CRAs. (resolved

Investigator’s payments discrepancies)

• Assisted in developing, planning, monitoring and evaluation of manpower.

• Ensured that CRAs are appropriately trained and performed their assigned activities in

compliance with standard operating procedures and national regulatory requirements.

• Allocated appropriately skilled and experienced CRAs to projects.

• Assisted Clinical Team (CTL) and Clinical Research Associates (CRAs) juniors with

accurately updating and maintaining clinical systems.

• Ensured all batches of IMP manufactured are QC for compliance with the product.

• Communicated with other Clinical Managers and their clinical teams to schedule quarterly

investigator payments (and tracking of missing reports)- (resolved outstanding queries)

• Utilized understanding of all aspects of US/CA and EU(UK,FR, Slovakia, Bulgaria, etc

regulatory processes.(to help with ICF translation from English to French and other)

• Performed Study Start up, Submissions to Canada IRBs, US central IRBs, and EU

documents. (accelerated activities and met deadlines)

• Assisted with translation of documents for IRB submission.(100% approval by Copernicus)

• Assisted STLs with preparation, handling and distribution of clinical trial supplies.(satisfied

Sites inventory demand)

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• Followed up with tracking and management of Case Report Forms (CRFs), and clinical data

flow. (queries resolution)

• Acted as a central contact for the clinical team for designated project communications in

French, correspondence and associated documentation.

Proposal Developer 2010-2011

• Reviewed Requests For Proposal (RFP). Identified information for proposal text and budget

development and worked closely with proposal development team to prepare and finalize

proposals.

• Prepared text and budget for proposals, rebids and related documents.

• Participated in strategy calls to discuss customer requirements and identified discrepancies.

• Performed quality control edits on all documents and participated in the finalization of

documents and distribution to the customer and internal departments.

• Updated and maintained corporate databases as required and ensured accurate information is

included in tracking reports.

• Coordinated global shipments of lab results between countries. (all products reached

destination)

• Prepared and distributed status, tracking and project finance reports – timely reports for

Outsourcing / Budget Dept. resulting in Project Awards.

• Managed Laboratory Events Schedule for different group of Patients (Oncology, CNS,

Cardiology – Urology, Allergy, infectious disease etc.).

Communicated with budget managers about multiple studies and lab tests taking place

simultaneously in different countries.

Created Global Lab Events schedule spreadsheet using Excel database per protocol. (adopted

by entire department)

UCB PHARMA, INC. – Smyrna, GA 2000-2009

CPM Assistant (Promotion) (2005-2009)

• Sites Monitoring, and Conducted internal audits – Mock FDA audits. (prepared report

findings)

• Studies reviewed, and ensured completeness for FDA Inspections. (no 483 Form)

• Verified US / EU GMP with Contract vendors for batch release and QC certification.

(improved process)

• Managed documents for 35 live clinical trials studies with accuracy. (passed FDA audit)

• Acted as quality control agent during site selection, monitoring visits.

• Input to Standard Operating Procedures (SOP) – to CRF design (made recommendation)

• Saved the company money by maintaining global communication with Europe / Canada

and Mexico in French and Spanish (including email translation).

• Developed coding system for clinical trial documents classification. (adopted company-wide)

• Assisted with development of project management plan and sites qualification. (identified sites

weakness)

• Assisted with clearance of sites selection, initiation, monitoring, and close-out.

• Conducted all clinical site activities according to the Monitoring Plan.

• Coordinated all activities required to support the drug distribution process, labeling,

including acting as the communication person for collation of essential regulatory documents

for assigned projects in accordance with the protocol, ICH-GCP.

• Adept at managing multiple projects, filing of clinical trial protocols, informed consent, IRB,

Monitoring Report, Case Report Form, Clinical Study Report, etc.

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• Trained and provided computer access level to CRCs – CRAs – CPMs.

UCB PHARMA, INC. - QC Associate to CRA (2000-2005) (continued)

CRA Roles

• Managed administrative activities associated with the conduct of clinical trials.

• Maintained research project databases (Impact), (CTMS); developed documents tracking

system for TMF.

• Performed site qualification, initiation, interim monitoring and study closeout visits for Phase I-

II studies in accordance with federal regulations, Client SOPs, Good Clinical Practices (GCPs),

ICH Guidelines.

• V Assisted in developing recruitment strategies, screening, and feasibility questionnaires.

• Interfaced with Participants to determine Inclusion/Exclusion criteria.

• Verified consent forms per Study Protocol and Regulatory procedures.

• Conducted all clinical site activities according to the monitoring plan and in accordance with

the study timelines and company objectives.

• Verified the Completeness of source documents/Case Report Forms (CRF).

• Ensured compliance with research protocols, reviewed Monitoring reports.

EDUCATION

Bachelor of Science, Health Care Services (BSHCS)

University of Phoenix – Dunwoody Campus, GA

Nursing Program: Essex County College

Accounting Diploma, MAURICE LAROCHE, P-AU-P.

Real Estate (sold for 3 years F/T) – JORDAN BARIS, Inc. N.J. (license expired)

SKILLS

Systems Used for Clinical Trials Studies:

• Software: CTMS – INFORM – CI-INFORMANT-DTS – INNTRAX – CRF Navigator

(scanning) – Social Media – WordPress – Photoshop – Adobe - SupplyX

• Computer Literacy: Microsoft Outlook, MS Word, Adobe, Access Excel I-II – PowerPoint

-INFORM-DTS–INNTRAX – INTRALINKS –IVRS –CAPAs -Oracle Clinical –Visual Source

-EDMS – CTMS – IMPACT - CRF Navigator (Scanning)–Clinical Informatics (CI)--e-CTS--

SAFRANS System Informant CONNEXUS IRB-Services – Share point.

• Other: press releases, social media posts, blogs, articles, word press, case-studies.

TRAINING PROFILE

• Clinical Research Associate Training (KRIGER International).

• Clinical Research Associate Training (Barnett program).

• Barnett Professional Services (GCP training – 2012)

• Good Clinical Practice: ICH – QP GCP – cGMP- GLP- GTP- EMEA Regulations.

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• Quality Assurance - Quality Control - IT security – Sales & Marketing

• Standard Operating Procedures: Clinical Study SAE Summary Reporting.

• Clinical Trial authorization (CTA) training. -HIPAA – OSHA – JCAHO – ISO 9000

• Technical Writing, Editing, Business Communication – Art / Photography

LANGUAGES

• Fluency in reading, writing, speaking English, French, and Spanish.

• Read and basic in German, Italian, Portuguese, and Dutch.

PUBLICATIONS

“Backup Skills for a Tough Job Market” –

Author: Davi Sal –www.backupskills.com – copyright 2013

Contact this candidate