Project Manager Medical
Resume:
Phyllis D. Hall
Durham, NC 27572
919-***-**** (Phone)
**********@*****.***
OBJECTIVE
To continue growth and development in the area of clinical research and to gain experience in the area of cancer research.
EMPLOYMENT
November 17, 2011-May 04, 2012
Clinical Nurse Reviewer
Assured the integrity of clinical data with respect to review of the medical record, clinical procedures, and to ensure physician compliance with patient visit procedures.
Patient file review and provide critial data for analysis.
Conduct Hedis reviews, HCC reviews visits and data submission.
Assist with document assess per specific disease review.
October 6, 2008-Nov. 20, 2010
Sr. Clinical Research Associate, Quintile,s RTP, NC
Obtained, tracked and reviewed regulatory documents
Assured the integrity of clinical data with respect to review of Case Report Forms (CRFs), source documents, medical records and electronic data capture (InForm, RAVE).
Oversee ongoing clinical trials of investigational drugs to ensure compliance with the FDA Regulations.
Master File and Essential Document file review and reconciliation as required.
Conduct initiation, interim monitoring and close out site visits.
Assist with protocol issues, study drug shipment and document retrieval and corrections.
Assist with the mentoring of new study staff.
Therapeutic area: Urology, CNS (CA Pain, Neuropathic pain, Arthritis pain), Adult ADHD, Endocrine
October 4, 2007-August 1, 2008
Sr. Clinical Research Associate for Assent Consulting, ( Novo Nordisk, Inc.)
Assisted in the process of selection of sites to participate in clinical trials and manage the study start up process.
Obtained, tracked and reviewed regulatory documents
Assured the integrity of clinical data with respect to review of Case Report Forms (CRFs), source documents, medical records and electronic data capture (InForm).
Oversee ongoing clinical trials of investigational drugs to ensure compliance with the FDA Regulations.
Master File and Essential Document file review and reconciliation as required.
Conducted pre-study, initiation, and interim monitoring site visits.
Assist with protocol issues, study drug shipment and document retrieval and correction s.
Assist with the mentoring of new study staff.
Therapeutic area: Diabetes
July 24. 2006-July 13, 2007
Sr. Clinical Research Associate for Clinical Resource Network, (Covance, Inc.)
Assisted in the process of selection of sites to participate in clinical trials and manage the study start up process
Obtained, tracked and reviewed regulatory documents
Oversee ongoing clinical trials of investigational drugs to ensure compliance with the FDA Regulations.
Conducted pre-study, initiation, interim monitoring and close-out study site visits.
Assist with the mentoring of new study staff.
Assured the integrity of clinical data with respect to review of Case Report Forms (CRFs), source documents, medical records and electronic data capture (InForm).
Therapeutic area: Respiratory (Asthma), Anti-Infectives, CNS (Parkinson's)
December 15, 2005-May 31, 2006
Senior Clinical Research Associate, Kendle, Inc.
Assisted with the development of informed consents forms, and CRF instructions. Training materials and other monitoring tools.
Assisted in the process of selection of sites to participate in clinical trials and manage the study start up process
Obtained, tracked and reviewed regulatory documents
Oversee ongoing clinical trials of investigational drugs to ensure compliance with the FDA Regulations.
Assured the integrity of clinical data with respect to review of Case Report Forms (CRFs), source documents, and medical records.
Conducted pre-study, initiation, interim monitoring and close-out study site visits.
Therapeutic area: Oncology
Oct. 15, 2005-December 30, 2005
Contract Clinical Research Auditor, Medical Staffing Network (Norwich Research)
Audit Clinical Research utilizing International Conference on Harmonization (ICH) Good Clinical Practice Guidelines.
Data verification to source documentation
Implement corrective action planning
Site and Sponsor Liaison
Adverse event tracking as assigned by Project Manager
Master File and Essential Document file review and reconciliation as required
Therapeutic area: Devise (Orthopedic)
August 3, 2005-August 19, 2005 (Project placed on hold)
Contract CRA for Monitor For Hire ( PRA)
Oversee ongoing clinical trials of investigational drugs to ensure compliance with the FDA Regulations.
Assisted in the process of selection of sites to participate in clinical trials and managed the study start up process.
Obtained, tracked and reviewed regulatory documents.
Conducted pre-study, initiation.
Assisted with the development of informed consents forms, and CRF instructions. Training materials and other monitoring tools.
Therapeutic area: Respiratory
November 4, 2004-June 17, 2005
Contract CRA for Pharmaceutical Careers (DOV Pharmaceutical, Inc.)
Assisted in the process of selection of sites to participate in clinical trials and manage the study start up process
Obtained, tracked and reviewed regulatory documents
Conducted pre-study, initiation and monitoring visits.
Assured the integrity of clinical data with respect to review of Electronic Case Report Forms (CRFs), source documents, and medical records.
Insure regulatory compliance
Therapeutic area: CNS (Pain Management; Lower Back)
May 17, 2004-September 17, 2004
Contract Senior CRA for Kelly Services (PPD)
Assisted in the process of selection of sites to participate in clinical trials and manage the study start up process
Obtained, tracked and reviewed regulatory documents
Conducted pre-study and initiation monitoring visits.
Assured the integrity of clinical data with respect to review of Case Report Forms (CRFs), source documents, medical records.
Therapeutic area: Cardiology
April 9, 2003-April 16, 2004
Contract Nurse Reviewer for Perigee, Contract Senior CRA for ICON, Contract
Nurse Consultant for Quality Staffing, Contract Senior CRA for i3 Research
Assisted in the process of selection of sites to participate in clinical trials and manage the study start up process
Obtained, tracked and reviewed regulatory documents
Conducted site initiations
Provide medical information to consumers and health care providers.
Research and responding to inquires.
Identify and record adverse events and product complaints
Obtained, tracked and reviewed regulatory documents
Conducted pre-study and initiation monitoring visits.
Site review
Hedis medical record review
Insure regulatory compliance
Therapeutic area: Hyperlipidemia in ACS, Benign Prostate Hypertrophy
March 19, 2001-Oct. 4, 2002
Clinical Research Associate, II
Covance, Inc., Princeton, NJ
Oversee ongoing clinical trials of investigational drugs to ensure compliance with the FDA Regulations
Assisted in the process of selection of sites to participate in clinical trials and manage the study start up process
Obtained, tracked and reviewed regulatory documents
Conducted pre-study, initiation, interim and closeout monitoring visits.
Ensure the correct coding of terminology on CRFs and proper documentation and management of adverse events.
Assured the integrity of clinical data with respect to review of Case Report Forms (CRFs), source documents, medical records and electronic data capture.
Communicated with sites regarding protocol issues, study drug shipment and document retrieval and correction.
Therapeutic areas: Hypercholesterolemia, Overactive Bladder, Insomnia (CNS)
Nov. 15, 2000-Feb. 23, 2001
Senior Clinical Research Associate (Contract)
Concepts in Pharmaceutical Research, Vero Beach, FL
Assured the integrity of clinical data with respect to review of Case Report Forms (CRFs), source documents, medical records and electronic data capture
Oversee ongoing clinical trials of investigational drugs and ensure compliance with FDA regulations.
Assist with the study start up process
Ensure the correct coding of terminology on CRFs and proper documentation and management of adverse events.
Conducted pre-study, initiation, interim and monitoring visits.
Participate in CRA or protocol specific training and development activities.
Assisted with the study start up process.
Obtained, tracked and reviewed regulatory documents.
Assist with protocol issues, study drug shipment and document retrieval and corrections.
Therapeutic area: Community Acquired Pneumonia, Candidasis and Uncomplicated Skin Wound
Oct. 18, 1999-Oct. 2000
Clinical Data Coordinator
Celeris Corporation, Morrisville, NC
Assist in the development of Case Report Forms
Process Case Report Form pages for Data Entry
Assist with the writing, distribution and retrieval of Data Clarification Forms
Develop Data Management Guidelines
Develop Data Entry Guidelines
Perform Edit Check
Assist with Screen Testing for data entry
Perform Medical Coding
Therapeutic areas: Cardiovascular, HIV, Diabetes
July 26, 1999-Oct. 1, 1999
Contract Nurse Reviewer for Aperture
Aperture, Louisville, KY 40222
Site Credentialing for insurance companies
Site Re-Credentialing for insurance companies
Site review
Medical record review
Insure regulatory compliance
1997-June 15, 1999
Contract Clinical Research Associate for Clinical Trials Support Services,
The Woolf Grop
Durham, NC
1996-1997
Clinical Research Associate
Duke Clinical Research Institute, Durham, NC
1995-1996
Clinical Research Associate
ClinTrials Research Inc., Research Triangle Park, NC
1993-1995
Triage Nurse
Duke Family Medicine, Durham, NC
1984-1993
Assistant Head Nurse, Neurosurgery
Pitt County Memorial Hospital, Greenville, NC
Unit Charge Nurse
Duke University Medical Center, Durham, NC
EDUCATION
1984
Associate Degree
Roanoke Chowan College, Ahoskie, NC
Saint Joseph College, Currently Attending
Major: Nursing
Licensed as a Registered Nurse in the state of NC: Certificate # 088530
CCRP Certification
Society of Clinical Research Associates, June 2011
REFERENCES Donna Mosser 803-***-**** (Manager)
Rhonda Cross 678-***-**** (Manager
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