ANTHONY M. JEFFRIES

*** ****** ******

Plainfield, NJ 07062

908-***-****(H)

(908) 242 - 0456 (M)

w9nntl@r.postjobfree.com (email)

Background:

** ***** ********** ** ******** development (domestic and international) providing clinical research expertise, site monitoring leadership, and management of clinical trial activities

• Execution of global clinical trial management

• Conducting clinical trials according to ICH and FDA Good Clinical Practices (GCPs) regulations/guidelines, and to company Standard Operating Procedures (SOPs) and policies

• Phases of clinical research includes early development/experimental medicine/Phase I as well as Phase II & III

• Managed large scale global clinical trials e.g. Phase II - 2000 Patients in 21 Countries & Phase III – 16500 patients in 64 countries

• Experience in managing study vendors

Work Experience:

October 2011 – Present Covance (Contract position)

Regional Senior Clinical Research Associate (Independent Contractor)

Therapeutic Concentration: Phase II & III: CNS, Infectious Disease, Hematology, Nephrology (Dialysis)

• Gathered essential documents and conducted study start-up activities

• Verified site study files for completeness and accuracy

• Monitored and managed clinical trials in the US and Canada as contracted by sponsor companies

• Investigator/Site Recruitment

• Conducted Pre-study, Initiation, Interim Monitoring, and Closeout Visits

December 2009 – May 2011 Forest Research Institute (Contract Position)

Clinical Research Scientist

Therapeutic Concentration: Phase III: Endocrinology/Metabolic, Cardiovascular

• Lead for xUS regions of Eastern & Western Europe, Russia and Ukraine

• Supervised, planned and coordinated clinical trial set-up and execution, budget management, patient recruitment/retention, clinical database development, oversight of clinical study closure execution, & clinical supply management

• Serving as the central point of contact and effectively manage relationships between members of the trial teams, CROs, sites and third party vendors.

• Obtained local and regional country specific insurance policies that fall outside global coverage

• Planned and managed clinical trial (s) to ICH and FDA Good Clinical Practices (GCPs) regulations/guidelines

• Conducted Clinical Oversight Monitoring Visits

• Participating in the selection of investigators and study sites

• In collaboration with the Regional Field Managers, development clinical Monitoring Plan

• Collaborate as part of the Study Team with Data Management, in the development of case report forms and participate in the EDC process, when appropriate

• Participated in the planning of investigator meetings and making presentations as required

• Participated in the preparation of project-specific training programs and training materials

• Participated in the review of clinical data at the CRF, data listing, and report table levels

March 2009 – July 2009 Lifecycle Pharma

Clinical Operations Manager

Therapeutic Concentration: Phase II & III: Transplantation Medicine

• Planned and managed clinical trials at various stages of completion, ensuring that regulatory, logistical details, enrollment, training needs, milestones, budgets and timelines are met

• Served as the central point of contact and effectively manage relationships between members of the trial teams, CROs, sites and third party vendors.

• Maintained regulatory documentation, site enrollment logs, status reports, clinical tracking reports, screen failure logs, waiver logs, protocol deviation logs, drug shipment accountability and effectively communicate with the Sr. Manager, Clinical Operations and all other appropriate parties about project progress, issues and changes

• Reviewed and ensured of critical trial documents (protocols, ICFs, CRFs, EDC, IVR specifications, etc) for compliance, completeness, and accuracy

• Conducted Clinical Oversight Monitoring Visits

• Ensured CRO/Company communication is complete, accurate and timely within compliance of standards and timelines

• Participated in the response to audit findings of study activities

• Participated in the development and maintenance of clinical trial outlines, synopses, protocols, and amendments. Investigators Brochures, IND Annual Updates and other documents as required.

• Participated in the implementation of clinical study reports, abstract presentations, and manuscripts of clinical study findings and results

• Provided assistance with financial aspects of clinical component of projects including initial negotiations as well as day-to-day management of budget and deliverables

• Assisted in the evaluation and selection of vendors with a view towards long-term vendor-client relationships and vendor management

February 2007 – April 2009 Daiichi Sankyo Pharma Development

Sr. Clinical Research Associate

Therapeutic Concentration: Phase II & III: Cardiovascular & Hematology

• Managed large scale global clinical trials (Phase II - 2000 Patients in 21 Countries & Phase III – 16000 patients in 64 countries) in the North and South America, Eastern and Western European, and the Asia - Pacific regions per ICH and FDA Good Clinical Practices (GCPs) regulations/guidelines

• Selected and managed global vendors including CROs, meeting planners, translation providers, central laboratories, IRBs, insurance brokers, central ECG vendors, electronic data capture (eDC) providers

• Execution of global clinical trial management: Supervised, planned and coordinated clinical trial set-up and execution, budget management, patient recruitment/retention, clinical database development, execution of clinical trial closure,& clinical supplies management

• Reviewed study pertinent documents for accuracy including protocols, study specific Operations Manual Clinical Study Reports Investigator’s Brochures, Data Monitoring/Safety Committee Charters, Monitoring Plan, Statistical Analysis Plans, Data Management Plans and edit specifications, IVR Plans, Investigational Product Plans

• Obtained local and regional country specific insurance policies that fall outside global coverage

• Completed Vendor RFP Statement of Work (SOW) documents

• Prepared clinical section of FDA Annual IND Review Document

• Coordinated appropriate specific protocol training site and site management personnel

• Planned and executed global investigator meetings, Date Safety Committees, and Adjudicating Committees

• Liaised with interdepartmental teams, providing proving study and departmental updates and coordinating departmental specific deliverables

November 2004 – March 2006 Johnson & Johnson Pharmaceutical

Research & Development (PRD)

Clinical Research Associate

Therapeutic concentrations: Phase I Experimental Medicine & Early Development: Cardiovascular, Oncology, CNS, Pain Management

• Managed Phase I - Early Development/Experimental Medicine, i.e. 1st in human, PK, PD, Dose Escalation, and Bio-availability trials in the US and Western Europe to ICH and FDA Good Clinical Practices (GCPs) regulations/guidelines

• Liaised with other Johnson & Johnson R & D companies on integrating electronic data capture into their clinical trials

• Trained investigators and staff on protocol specifics and use of electronic data capture technology

• Maintained documentation of all activities related to site selection, monitoring, data collection and verification.

• Monitored subject dosing and assessment

• Identified and assessed possible investigators or CROs for clinical studies

• Initiated drug requests and maintains adequate supply at investigational sites.

• Ensured on-going communication with internal study personnel including the Project Leader, Clinical Research Scientist, Medical Monitor, Bio-statistician, Data Manager, Regulatory Associate, QA, and Clinical Research Manager (CRM)

• Prepared for and participated in QA, FDA and Foreign regulatory agencies inspections audits

• Verified site study files for completeness and accuracy

April 2000 – January 2004 Purdue Pharma L P

Senior Clinical Research Associate

Therapeutic concentrations: Phase I, II, & III: Endocrinology/Metabolic, Pain Management, Pediatrics

• Execution of global clinical trial management: Supervised, planned and coordinated - including trial set-up and execution, budget management, patient recruitment/retention, clinical database development, execution & closure oversight, and clinical supplies management

• Participated in the development of departmental Standard Operating Procedures and Working Practice Documents (SOPs/WPDs)

• Gathered essential study documents (including FDA Form 1572, DEA forms 222 and 223, Investigational Review Board (IRB) required documents – approved Informed Consent, protocol approval, etc

• Monitored and managed clinical trials in the North and South America per ICH and FDA Good Clinical Practices (GCPs) regulations/guidelines

• Verified site study files for completeness and accuracy

• Development Case Report Forms (CRF) and data completion guidelines

• Developed/Maintained Clinical Monitoring Plan

• Ensured on-going communication with internal study team

• Initiated drug requests and maintained adequate supply at investigational sites.

September 1998 – March 2000 Covance

Regional Clinical Research Associate

Therapeutic concentrations: Phase II and III

Cardiovascular Endocrinology Musculoskeletal Ophthalmology

Critical Care Gastroenterology Medical Devices Pain Management

CNS Gynecology Men’s Health Pulmonary

Emergency Medicine Infectious Disease Oncology

• Monitored and managed clinical trials in the US and Canada as contracted by sponsor companies to ICH and FDA Good Clinical Practices (GCPs) regulations/guidelines

• Investigator/Site Recruitment Gathered essential documents and conducted study start-up activities

• Verified site study files for completeness and accuracy

• Conducted Pre-study, Initiation, Interim Monitoring, and Closeout Visits

September 1997 – September 1998 Analytical Sciences, Inc. (ASI)

Clinical Research Associate

Therapeutic concentrations: Phase II, III, and IV

CNS Dermatology Oncology

Cardiovascular (HITTS) Gastrointestinal Pediatrics

• Monitored & managed assigned Clinical Study Sites in the United States and Canada per ICH and FDA Good Clinical Practices (GCPs) regulations/guidelines

• Gathered essential documents and conducted study start-up activities

• Initiated and maintained central files

• Verified site study files for completeness and accuracy

• Developed CRF completion guidelines

• Conducted Pre-study, Initiation, Interim Monitoring, and Closeout Visits

• Development of Source Documentation worksheets templates

• Source Document Verification (SDV) of patient medical files against subject case records

• Generated and resolved data queries

Education:

University of North Carolina at Greensboro

Bachelor of Arts: History

Minor: Sociology

Professional Organizations

American Society for Clinical Pharmacology and Therapeutics (ASCP)

Association of Clinical Research Professionals (ACRP)

Drug Information Associate (DIA)

Society of Clinical Research Associates (SoCRA)

Certifications:

Association of Clinical Research Professionals (ACRP)

Medical Coding Terms

COSTART MEDRA

Computer Experience

Windows XP FoxPro Databases Documentum Lotus-notes Sophocles

DataTrak (eDC) Medidata (RAVE) MS Excel MS Outlook MS Power Point MS Word Phoenix Data Systems (eDC) Phase Forward/Inform (eDC)

Siebel eClinical Medidata RAVE

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