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RN

Location:
Cary, North Carolina, 27513, United States
Salary:
$96,000
Posted:
May 28, 2010

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Rabecca Klemp, MS, RN, CCRA

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

Cary, North Carolina 27513

919-***-****

e-mail: xxy2b1@r.postjobfree.com

Professional Experience

Omnicare Clinical Research, Cary, NC 2007-Present

Regional Senior Clinical Research Associate

Therapeutic Areas: Anemia/chronic kidney disease, gastrointestinal, flu vaccine, and oncology (bladder, colorectal, pancreatic, ovarian, and breast cancers)

• Conducted routine monitoring visits for Phase I oncology study (two protocols and five types of cancers: bladder, colorectal, pancreatic, ovarian, and breast cancers) to confirm adherence to protocol and regulatory requirements

• Conducted routine monitoring and closeout visits for Phase II anemia/chronic kidney disease (in nursing homes), gastrointestinal, and flu vaccine studies to confirm adherence to protocol and regulatory requirements

• Involved in study start-up activities including pre-study and initiation visits

• Comprehended, followed, and implemented GCP guidelines and 21 Code of Federal Regulations (CFRs) ensuring clinical monitoring services were performed within industry guidelines

• Collected, reviewed, and evaluated regulatory documents to meet sponsors and FDA requirements

• Monitoring Electronic Case Report Forms including training site personnel on the systems

• Management of 10-13 sites including weekly phone contacts

PharmaNet, Cary, NC 2003 – 2007

Senior Clinical Research Associate/Lead Clinical Research Associate

Therapeutic Areas: Cardiology and endocrine

• Select and monitor Investigator sites

• Develop study tools, advertisements, and guidelines for site use

• Develop Monitoring Plan and Project Plan

• Develop processes such as SAE procedures and protocol exemption procedures

• Develop Gantt charts and timelines

• Track and maintain regulatory documents and project tasks

• Worked with clinical supply center to ensure adequate supply at the sites

• Worked with Data Management and Biostatistics departments in database generation

• Review lab results for inclusion/exclusion criteria

• Organize processes with vendors such as central labs, centralized radiology facility, and printers

• Organize and present at Investigator’s meetings

• Lead team meetings with sponsor and internal team

• Develop and edited protocols and Case Report Forms (CRFs)

• Provide training to other clinical research personnel including Lunch & Learn sessions to educate peers on current information from job-related conferences

• Prepare status reports for clients and PharmaNet management

• Negotiate budgets, prepare contracts and make payments to study sites

Resource Solutions Inc., Cary, NC 2001 – 2003

Senior Clinical Research Associate

Therapeutic Area: women’s health

• Conducted routine monitoring for a Phase III female testosterone study

• Involved in study start-up activities including site recruitment, pre-study, and initiation visits

• Comprehended, followed, and implemented GCP guidelines and 21 Code of Federal Regulations (CFRs) ensuring clinical monitoring services were performed within industry guidelines

• Initiated and participated in study start-up activities; including preparation of study materials as well as attendance and presentation at Investigators’ meetings to meet organizational requirements of a clinical drug trial

• Identified and recruited investigational sites for participation in clinical trials to facilitate selection of sites capable of completing protocol requirements

• Planned, coordinated, and conducted pre-study visits to evaluate and qualify sites for participation in clinical drug studies

• Collected, reviewed, and evaluated regulatory documents to meet sponsors and FDA requirements

• Coordinated and conducted interim monitoring visits to confirm adherence to protocol and regulatory requirements

• Participated and assisted sites in patient recruitment activities to meet guidelines

• Requested grant payments for Clinical Investigators to fulfill sponsor’s financial obligations

• Identified, processed and evaluated SAEs to meet FDA guidelines

• Initiated, evaluated, and processed data clarification queries to ensure accuracy of data

• Coordinated and conducted site closeout visits

• Served as lead CRA on a Phase III pain management study for three months

• Responsibilities included reviewing pre-study trip reports

Pharmalink FHI Inc., Research Triangle Park, NC 2000 – 2001

Clinical Research Associate

Therapeutic Area: cardiology

• Participated in the Investigator recruitment process for a Phase IIIb cardiology study

• Obtained and reviewed regulatory documentation for CFR and GCP guidelines

• Worked with sites to obtain IRB approval of protocol and informed consent forms

• Performed study initiation activities and reviewed with the site personnel the protocol, regulatory issues, and study procedures with site personnel

• Conducted training on completion of the Inform eCRF system

• Documented accountability, stability, and storage conditions of clinical trial materials

• Reviewed eCRFs for completeness, clarity and conformity to available source documents and adherence to the protocol

• Performed routine study monitoring visits per company SOPs to ensure FDA regulations, GCP guidelines, and protocol requirements were being followed at the Investigational site

• Assisted in the preparation of protocols, CRFs, study manuals, and other related documents

Aerotek, Inc., contracted to Duke Clinical Research Institute Raleigh, NC 1999 – 2000

Clinical Research Associate

Therapeutic Areas: cardiology, infant cardiopulmonary bypass, neurology

• Provided clinical research services on a Phase III cardiology and neurology study and a Phase I-II infant cardiopulmonary bypass study

• Reviewed regulatory documents for CFR and GCP guidelines

• Conducted and documented pre-study site, initiation, monitoring, and closeout visits

• Conducted internal and site file audits

PPD Pharmaco, Morrisville, NC 1997 – 1999

Clinical Research Associate

Therapeutic Areas: osteoarthritis, prostate cancer

• Participated in a Phase I/II – Phase III testosterone-lowering prostate cancer study for one and a half years

• Participated in a Phase IIIb osteoarthritis study

• Conducted and documented pre-study site, initiation, interim monitoring, and closeout visits ensuring adherence to protocol requirements, GCP guidelines, and FDA regulations

• Reviewed regulatory documents for CFR and GCP guidelines

• Conducted internal and site file audits

• Trained new CRAs to pre-study and initiation visits and interim monitoring visits

WakeMed Hospital, Raleigh, NC 1997

Registered Nurse (Float pool)

• Provided direct nursing services on various Medical Surgical units, including Telemetry

Mary Washington Hospital, Fredericksburg, VA 1997

Registered Nurse (Traveling Nurse)

• Worked on 31-bed oncology unit with direct care responsibility for six patients

• Delegated assignments to nursing assistants

Personal Touch Home Health Care, Baltimore, MD 1996– 1997

Case Manager, Registered Nurse

• Coordinated home health services for Medicare patients

• Conducted home health assessments for up to 30 home health visits per week

• Participated in case management discussion with home health physicals therapists, social workers, and administrative staff

• Reported status of patient upon admission, during home health visits, and discharge to referring physician

Sinai Hospital, Baltimore, MD 1994 – 1996

Registered Nurse/Charge Nurse (Float pool), part time

• Assigned and supervised staff of up to eight on 32 bed Medical - Surgical units

• Trained new staff and assisted as needed

• Made discharge planning rounds

Memorial Medical Center, Jacksonville, FL 1992 – 1994

Crouse-Irving Memorial Hospital, Syracuse, NY

Medical College of Virginia, Richmond, VA

St. Luke’s Hospital, Kansas City, MO

Athens Regional Medical Center, Athens, GA

Sinai Hospital, Baltimore, MD

Traveling Registered Nurse

Therapeutic Areas: general surgery, neurology, oncology, orthopedic, urology, vascular-thoracic

• Worked as a traveling nurse for various hospitals

• Initiated intravenous therapies and medications

• Assigned and supervised staff members

Duke University Medical Center, Durham, NC 1991– 1992

Registered Nurse/Primary Nurse

• Worked on a 32-bed general medicine and pulmonary-renal unit

• Made discharge planning rounds

• Set up home care for patients upon discharge

• Performed unit-level quality assurance data collection

• Completed a one year General Medicine Nursing Internship

Education

University of Maryland, Baltimore, MD MS – Intercultural Community Health Nursing

University of North Carolina, Chapel Hill, NC BSN – Nursing License # 116551

North Carolina State University, Raleigh, NC BA – Political Science

Professional Memberships / Certifications

Association of Clinical Research Professionals

Certified Clinical Research Associate

Professional Courses

Project Management Course, ACRP February 2005

MS Project Course November 2004



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