Clinical Research Manager

Location:

New York, NY

Posted:

March 30, 2015

Contact this candidate

Resume:

Karen L. Rogers, M.S.

*** ********* ***** ******, ***********, SC 29483

EDUCATION

**** *.*.*., *******

Ocean County College

Toms River, New Jersey, USA

**** *.*., Nutrition Science

Pennsylvania State University

University Park, Pennsylvania, USA

1977 B.A., Nutrition

Montclair State University

Upper Montclair, New Jersey, USA

PROFESSIONAL EXPERIENCE

Aug 2014 to Present Senior Clinical Research Associate

inVentiv Health Clinical

Cary, NC, USA

* Contract position with Klein Management Systems converted to CRO position

Jan 2014 to Aug 2014 Senior Clinical Research Associate

Klein Management Systems

Nanuet, New York, USA

* Participated in Novartis Flex Team assignments including COVs, IMVs and other tasks, as assigned to support the CORE CRA Team.

Sep 2011 to Dec 2013 Clinical Site Manager (Employee)

Bristol-Myers Squibb

Lawrenceville, New Jersey, USA

PROFESSIONAL EXPERIENCE, CONTINUED

Jan 2011 to Sep 2011 Clinical Site Manager (Contractor)

Bristol-Myers Squibb via Mindlance

Hoboken, New Jersey, USA

* Participated in Inspection Readiness Teams for 5 compounds

* Reviewed data safety listings

* Site management activities for United States and Puerto Rico (30+ sites) for 7 studies including review of CTP packages, ICF review, site training, issues management, data review, monitoring report review, trending of protocol deviations to secure compliance.

* Member of SME R.E.D. [Ready Every Day] Team 2/11 to 9/11; SME R.E.D. Team Lead 10/11 to 12/12.

* Facilitated monthly R.E.D. Team Meetings by leading an 8 member group of Site Managers and Site Monitor to improve inspection readiness

* Created tools to improve study files management

* Presented to study teams to remind and reinforce ALCOA principles of essential documents and ensure filing in the ESF

* Marketed R.E.D. Team through RCO Newsletter article and team SharePoint

* Liaised with GQRC and SFM to improve the study files management

* Enhanced knowledge of Site Managers and Site Monitors in principles of GCP and new regulations that affect the conduct of clinical trials.

Sep 2009 to Jul 2009 Senior Clinical Research Associate (Employee)

Vaxinnate Corporation

Cranbury, New Jersey, USA

Jul 2009 to Sep 2010 Senior Clinical Research Associate (Contractor)

VaxInnate Corporation via Sage Staffing Solutions

Manasquan, New Jersey, USA

* Wrote all company clinical forms and SOPs (PSV, SIV, IMV SCV Report Forms, Critical Document Checklist, Staff Responsibility Log, Screening &

PROFESSIONAL EXPERIENCE, CONTINUED

Enrollment Log, ICF Log, Protocol Waiver Form, Pregnancy Reporting Form, etc.)

* Wrote (approximately 15) and reviewed SOPs (approximately 30) for the Clinical Department (Scope, Responsibilities, References, Procedure, Abbreviations, Summary of Changes and Attachments) including Serious Adverse Event Management, Pregnancy Reporting, Conducting Site Visits, Trial Master File Management, Financial Disclosure of Sites, Data Management Plan, Informed Consent of Subjects, etc.

* Organized Trial Master File system with electronic trackers

* Monitored 2 studies (250 subjects) with ongoing site visits

* Coordinated weekly Safety Monitoring Committee Meetings with data trackers, AE logs, meeting minutes for over 4 months

* Wrote safety narratives for SAE submissions to FDA

* Wrote the following study documents: ICF, Monitoring Plan, CRFs, eCRF Guidelines, Data Management Plan, source document worksheets, study forms (dosing logs, IP accountability, IP preparation worksheets, randomization lists), etc.

* Completed data entry and data review in 2 electronic databases, wrote and issued Query Reports, ongoing communication with medical coder, statistician and SAS programmer, locked databases on 2 studies

* Trained sites on use of digital pen technology

* Initiated and designed Serology Inventory trackers with communication with Serology Laboratories

* Reviewed and tracked Trial Master File documents

Nov 2007 to May 2009 Principal Clinical Research Associate

ICON Clinical Research

North Wales, Pennsylvania, USA

* Completed source documentation and monitoring for 3 oncology (brain cancer protocols (12-18 sites) and ensured accurate completion of

PROFESSIONAL EXPERIENCE, CONTINUED

DataFax Forms

May 2007 to Nov 2007 Senior Clinical Research Associate

Novo Nordisk

Clintel Services

Germantown, Maryland, USA

* Participated in study start-up activities for a Phase III dialysis study

Nov 2005 to Apr 2007 Senior/Lead Clinical Research Associate

GE Healthcare

Princeton, New Jersey, USA

* Participated in all phases of study start-up and monitoring activities for 2 Phase III medical diagnostics/cardiology studies with a total of 1080 subjects

Sep 2004 to Nov 2005 Clinical Research Associate II

PharmaNet, Inc.

Princeton, New Jersey, USA

* Participated in Routine Monitoring Visits and Close-out Visits for 1 Phase II study

Feb 2003 to Aug 2004 Clinical Research Associate I

ICON Clinical Research

North Wales, Pennsylvania, USA

* Monitored 15 clinical research sites in compliance with Good Clinical Practice, Standard Operating Procedures, and Global and Local Corporate policies, guidelines, and standards.

Nov 2002 to Feb 2003 Clinical Trial Associate at Bristol-Myers Squibb

Pharmaceutical Clinical Associates

Trenton, New Jersey, USA

* Created and maintained tracker spreadsheets in Excel

* Maintained regulatory document files

* Participated in IPT Meetings

PROFESSIONAL EXPERIENCE, CONTINUED

Sep 2002 to Nov 2002 QC Specialist at RadPharm

ClinForce

Tampa, FL

* Reviewed source documents and radiology films to ensure consistency with GCPs on several study protocols

* Documented inconsistencies with recommendations for action to the Project Teams

Feb 2002 to Aug 2002 Lead Clinical Reviewer (Employee)

Premier Research

Philadelphia, PA, USA

Sep 2001 to Feb 2002 Lead Clinical Reviewer (Contractor)

Premier Research via Aerotek

Cherry Hill, New Jersey, USA

* Reviewed and validated the clinical data on the case report forms utilizing DataFax

* Contacted the Study Coordinators and Clinical Research Associates to expedite query resolution tracking results in Excel and Project Manager

LICENSURE/CERTIFICATION

2006 to 2014 Certified Clinical Research Associate

American Clinical Research Professionals

Alexandria, Virginia, USA

Previous certifications as Nutrition Support Nurse and Nutrition Support Dietitian (with ADA while in clinical practice)

SUMMARY OF PROJECT EXPERIENCE

Therapeutic Area, Sub Indication and Drug Class

Phase

Job Title

Oncology/Multiple Myeloma

Clinical Site Manager

Oncology/Head and Neck

Clinical Site Manager

Oncology/Breast

Clinical Site Manager

Cardiology/Atrial Fib

III

Clinical Site Manager

Oncology/Leukemia