Registered Nurse Project Manager

EDUCATION **** (Ongoing) Walden University

Graduate School of Nursing

MSN - Informatics

**** ******* **********, *******, ************

Graduate School of Nursing:

Foundations classes in Clinical Research Operations

1996 Widener University, Chester Pennsylvania

Bachelor of Science in Nursing (BSN)

WORK EXPERIENCE

Feb 2012 to Veterans Health Administration., Boston Health System,

Present FTE MA

Quality Assurance Nurse Specialist (QANS) (RN, BSN

required)

Provides clinical and regulatory guidance during all

phases of protocol development and implementation for

staff, both at the Center and at the participating

study site, to ensure compliance with regulations,

policies, and guidelines for Good Clinical Practice

(GCP).

Assist study teams to develop proactive operational

plans to reduce and manage protocol violations.

Assist the study team and national study coordinator

with new site personnel orientation and serve as a

clinical resource.

Perform informed consent form (ICF) review and

surveillance for compliance with federal and VHA

regulations.

Serve as a clinical resource for Coordinating Center

personnel.

Develop and periodically review Center work

instructions related to QA Nurse Specialist roles.

Conduct periodic remote surveillance of participants'

Aug 2011 to Feb medical records, as requested, for early detection of

2012 potential protocol deviations regarding: unreported

FTE serious adverse events (SAEs) and Inclusion/Exclusion

Criterion.

PRA International., Horsham, PA

Clinical Research Associate III (RN, BSN required)

Responsible for on-site monitoring of clinical trials.

Ensured adherence to good clinical practices,

investigator integrity, and compliance with all

protocol requirements and study procedures.

Verified Case Report Forms (CRFs) against source

documents for completeness and accuracy.

Reviewed regulatory documents for availability and

accuracy.

Performed clinical trial materials accountability.

Maintained communication with site personnel, project

team and sponsor.

Jun 2006 to Jul ReSearch Pharmaceutical Services, Inc., Fort

2011 Washington, PA

FTE Clinical Research Associate II (RN, BSN required)

Responsible for monitoring of the participant study

sites, as laid out in ICH/GCP chapter 5.18

'Monitoring'.

Duties and Responsibilities (including but not limited

to):

Adhere with corporate internal polices and

requirements, including submission of timesheets and

expense reports in a timely manner.

Conduct study feasibility and site selection activities

Develop and implement innovative approaches for and

participates in site recruitment, selection and

initiation activities.

Assist with investigator meeting activities including

organization, preparation and attendance

Conduct site management activities including but not

limited to site selection visits, site initiation

visits, site training, site routine monitoring visits,

and site close out visits.

Ensure the integrity of clinical data and adherence to

applicable regulatory, protocol, and company

guidelines.

Establish and maintain good rapport with study sites.

Write study visit reports and follow up letters within

the timeline established by applicable SOPs and

guidelines

Representation of CRAs during an audit or inspection

when assigned

Coordinate timely shipment of clinical supplies and

study drug to sites.

Ensure proper storage, dispensation and accountability

of clinical supplies and study drug.

Maintain adequate site tracking records

Follow up of drug safety issues and safety reports in

timely manner, if applicable

Communicate site study issues, concerns, and progress

to Project Manager, Clinical Team Lead and Clinical

Research Manager accordingly

Develop and implementation of corrective actions when

appropriate

Assist with data query form (incl. query process)

Prepare /review all patients tracking records

Input and maintain study information concerning subject

status of financial reimbursement to sites.

Conduct and assist with administrative activities as a

member of the project team.

Oct 2005 - Jun KForce, Inc., Tampa, Florida

2006 Clinical Research Site Manager (Regional) (RN, BSN

FTE required)

Contract consultant on assignment as CRSM for Pfizer

Clinical Studies.

Responsible for on-site monitoring of clinical trials.

Ensures adherence to good clinical practices,

investigator integrity, and compliance with all

protocol requirements and study procedures.

Verifies Case Report Forms (CRFs) via electronic data

capturing (eDC) against source documents for

completeness and accuracy.

Reviews regulatory documents for availability and

accuracy.

Performs clinical trial materials accountability.

Maintains communication with site personnel, project

team and sponsor.

Feb 2002 - Oct Quintiles, Inc., Atlanta, Georgia

2005 Sr. Clinical Research Associate (Regional) (RN, BSN

FTE required)

Responsible for on-site monitoring of clinical trials.

Ensured adherence to good clinical practices,

investigator integrity, and compliance with all

protocol requirements and study procedures.

Verified Case Report Forms (CRFs) against source

documents for completeness and accuracy.

Reviewed regulatory documents for availability and

accuracy.

Performed clinical trial materials accountability.

Maintained communication with site personnel, project

team and sponsor.

Apr 2001- Jan 2002 Aventis Behring, King of Prussia, PA

In-House Clinical Research Associate (RN, BSN required)

FTE

Responsible for completing project activities

applicable to the initiation, monitoring, and

summarization of clinical trials. Demonstrated the

fundamental knowledge of departmental SOPs and ICH/GCP

guidelines. Assisted with preparing

audits/inspections. Participated in drafting

protocols, case report forms and other research

documents. Tracked up-to-date status of assigned

investigational sites. Assisted in requesting and

compiling critical study documents in accordance with

regulatory requirements. Performed as a knowledgeable

liaison between Aventis Behring and the investigative

centers. Assist the Data Management department to

resolve queries via Oracle Clinical.

Mar 1999 - Feb Moss Rehabilitation, Philadelphia, Pennsylvania

2000 Registered Nurse

FTE Responsible for assessing biophysiosocial needs of

patients by collecting data on health history and

specimens.

Assessed social environment in relation to special

equipment and barriers needed to implement care.

Developed short/long term goals and evaluated desired

outcomes.

1997-1999 Arcadia Health Care Agency, Feasterville, Pennsylvania

PTE Registered Nurse

Responsible for delivery of competent quality patient

care at surrounding nursing homes via the development,

implementation and evaluation of individual patient

care plans.

Liaison between the agency, patients, and family

members.

1997 - 1998 Abington Memorial Hospital, Abington, Pennsylvania

FTE Registered Nurse

Responsible for monitoring heart monitors on the

telemetry unit.

Assessed signs and symptoms related to patients

admitting diagnoses and reporting abnormalities.

Fulfilled physicians' orders as well as collaborated in

creating a care plan.

Responded to code blue due to cardiac arrest.

Adhered to standards and code of ethics in the role of

nursing.

1987 - 1998 United States Postal Service, Philadelphia, PA and

(SF-50) Duluth, GA 1987 to 1998

FTE Postal Clerk

. Responsible as a postal clerk at the local post

office to sort local mail for delivery for individual

customers and provide retail services such as selling

stamps and money orders, weighing packages to determine

postage, and checking that packages are in satisfactory

condition for mailing. Also responsible to register,

certify, and insure mail and answer questions about

postage rates, post office boxes, mailing restrictions,

and other postal matters.

American Nursing Informatics Association (ANIA)

AFFILIATIONS Association of Clinical Research Professional (ACRP)

Sigma Theta Tau International (STTI) - Phi Nu Chapter

LICENSURE Pennsylvania Registered Nurse: RN-519760L -inactive

Florida Registered Nurse: RN-9263422 - active

Florida Realtor License: SL3215657 - expired

Century 21 and Zip Realty Florida - 2008 - 2010

CERTIFICATIONS Clinical Research

Basic Life Support

COMPUTER SKILLS Microsoft Office

Clinical Trial Management System (CTMS)

Electronic Data Capture (EDC)

CPRS / VISTA Web/CAPRI

Contact this candidate