Portland M. Pleasant, RN
**** *. ****** **., ***. #1933
Garland, TX 75044
***********@*****.***
PROFESSIONAL EXPERIENCE
Clinical Research Nurse
Baylor Research Institute, Dallas, TX January 2014 – Present
• Reviews new protocols and other materials provided by study sponsors and gives input to Principal
Investigator and Manager, as applicable, regarding Nursing and Research issues in order to determine
Financial and clinical feasibility
Coordinates implementation of various protocols for assigned Research projects with appropriate departments
throughout Baylor Health Care System (BHCS) by interacting with Principal Investigators and Clinical
Managers/Supervisors, providing in-service education for healthcare professionals and working with Pharmacy to
ensure a smooth project flow
Maintains communication with study sponsor and/or designee throughout study.
Screens patients for eligibility on assigned clinical trials in accordance with HIPAA standards.
Coordinates Research subject consent and entry into appropriate Research studies ensuring that all inclusion and
exclusion criteria are met.
Reports serious adverse events (SAEs) in a timely manner per study sponsor (or designee) and IRB
requirements.
Accurately completes case report forms in a timely manner.
Engages in positive working relationship with members of Clinical Trial Research Teams
Maintains current knowledge of departmental functions through reading literature, attending workshops, seminars
and conferences, and by participating in professional organizations
Regional Clinical Research Associate II
PAREXEL International, Waltham, MA January 2013 – November 2013
• Responsible for monitoring the conduct of clinical research studies
• Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the
proper conduct of studies, to review data and ensure data collected from start up to termination of studies and to
terminate studies.
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and
compliant with applicable local regulatory requirements and ICH guidelines.
• Performs investigative site file reconciliation, requests any new or updated si te-related essential and non-
essential documents and reviews them for content, consistency with other documents and compliance with
appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
• Performs source document verification, retrieves case report forms (CRFs) and performs query resolution in a
timely manner and oversees drug accountability and safety at investigative sites.
• Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information,
resolves queries and assists sites in completion of SAE reports.
• Generates visit reports and letters for site and project management using study specific software
Home Health Care Staff, PRN/RN
Mederi Caretenders Home Care Services, St. Louis, MO August 2012 – November 2012
• Perform health assessments in the homes of individuals and families by evaluating their physical, mental and
social and environmental health status; and provide nursing intervention based on assessment of need.
• Make skilled nursing observations and assessments of client health care status by monitoring and documenting
such things as vital signs, pulse, presence of edema, heart and lung auscultation, blood and urine laboratory
values, intake and output, consciousness and orientation levels; by completing a health history and evaluation,
and evaluating living arrangements.
• Provide case management for clients by developing care plans, consulting with other health care providers such
as physicians and social workers, referring clients to other disciplines.
• Participating in team meetings, coordinating health care services provided by ancillary personnel such as home
health aides, and instructing clients and families on methods of positive health maintenance; initiate and conduct
interdisciplinary conferences.
• Develop and provide health education and consultation services to community members, clients and family
members on a one-to-one and group basis through home visits, responding to requests for information by phone
or in person.
Director of Nursing
Family Home Health Services, St. Louis, MO July 2011-July 2012
• Recruits, hire and train staff in all aspects of home health including, Confidentiality/HIPAA, cultural sensitivity,
growth and development, corporate compliance, infection control, OASIS and chart documentation, and company
policies and procedures.
• Oversight of nurses, home health aides, and other supportive staff to implement and direct patient plan of care.
Performing supervisory visits for disciplines, conducting skills checklists of new hires and review of performance
review of skills.
• Ensuring that staff employed with the organization follows appropriate guidelines for homecare; providing patients
with the most complete coverage of care in scheduling; assigning discipline-specific team members to patients
based on acuity level.
• Conducts mandatory staff meetings and case conference to discuss patient status information and plan of care.
• Meets with the CEO to discuss company progress and to ensure that all office goals are being met.
• Develops and implements new policies and procedures as required.
• Ensures the safety of patients and staff.
Home Health Care Staff, RN
Pyramid Home Health Services, St. Charles, MO August 2010-December 2010
• Assessed and evaluated health status of home bound and evaluated the health status of home bound patients
• Educated and instructed patients and caregivers on home health care plans
• Coordinated home care with the interdisciplinary team, such as Physical and Occupational Therapy
• Performed venipuncture, IV therapies and wound care
• Ensured timely and appropriate documentation on patient records
• Maintained confidentiality of patient records, following the HIPAA rules
Home Health Care Staff, PRN/RN
Helping Hands Home Care Services, St. Louis, MO May 2010 – December 2010
• Assessed and evaluated health status of home bound and evaluated the health status of home bound patients
• Educated and instructed patients and caregivers on home health care plans
• Coordinated home care with the interdisciplinary team, such as Physical and Occupational Therapy
• Performed venipuncture, IV therapies and wound care
• Ensured timely and appropriate documentation on patient records
• Maintained confidentiality of patient records, following the HIPAA rules
Agency Staff Nurse/RN
Temps Incorporated, St. Louis, MO January 2008 – November 2009
• Performed all duties as a Registered Nurse in various medical surgical settings
• Planned and implemented patient care for up to 8 seriously ill patients per shift in the hospital setting
• Responsible for the care and management of patients experiencing many different medical diagnoses including,
but not limited to the following: Congestive Heart Failure, Coronary Artery Disease, Arrhythmias, Atrial Fibrillation,
End Stage Renal Disease, Diabetes Mellitus, Gastrointestinal Diagnoses and HIV/AIDS
• Assess patient status and notified physician of any clinical changes
• Provided education and instruction to patients and their families on healthcare needs, medical diagnoses and
healthcare options
• Maintained confidentiality of patient records, following the HIPAA rules
Regional Sr. Clinical Research Associate
Quintiles Transitional, Overland, KS August 2008 – September 2010
Provided monitoring and site management for a variety of complex protocols that require knowledge in advanced
therapeutic areas of pain management.
Administered protocol and related study training to assigned site personnel and established regular lines of
communication with site staff to manage ongoing project expectations and issues
Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the
proper conduct of studies, to review data and ensure data collected from start up to termination of studies and to
terminate studies.
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and
compliant with applicable local regulatory requirements and ICH guidelines.
Performs investigative site file reconciliation, requests any new or updated site -related essential and non-
essential documents and reviews them for content, consistency with other documents and compliance with
appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
Performs source document verification, retrieves case report forms (CRFs) and performs query resolution in a
timely manner and oversees drug accountability and safety at investigative sites.
Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information,
resolves queries and assists sites in completion of SAE reports.
Generates visit reports and letters for site and project management using study specific software
Maintained confidentiality of subject documents and records, following the HIPAA rules
Clinical Staff Nurse/RN (Weekend Option)
St. Anthony’s Medical Center, St. Louis, MO March 2008 – August 2009
• Performed all duties as a Registered Nurse on a 32-bed Cardiac Telemetry Unit
• Planned and implemented patient care for up to 8 seriously ill patients per shift in the hospital setting
• Responsible for the care and management of patients experiencing various cardiac Assess patient status and
notified physician of any clinical changes
• Provided education and instruction to patients and their families on healthcare needs, medical diagnoses and
healthcare options
• Maintained confidentiality of patient records, following the HIPAA rules
Regional Clinical Research Associate II
Kendle International, Cincinnati, OH February 2007 – August 2008
Monitored a Phase III double blind stud y in the therapeutic area of Pediatric Hepatitis B, managing 8 sites, and a
Phase IV study in the therapeutic are of Burns, managing 10 sites
Administered protocol and related study training to assigned site personnel and established regular lines of
communication with site staff to manage ongoing project expectations and issues
Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the
proper conduct of studies, to review data and ensure data collected from start up to termination of studies and to
terminate studies.
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and
compliant with applicable local regulatory requirements and ICH guidelines.
Performs investigative site file reconciliation, requests any new or updated site -related essential and non-
essential documents and reviews them for content, consistency with other documents and compliance with
appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
Performs source document verification, retrieves case report forms (CRFs) and performs query resolution in a
timely manner and oversees drug accountability and safety at investigative sites.
Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE informat ion,
resolves queries and assists sites in completion of SAE reports.
Generates visit reports and letters for site and project management using study specific software
Maintained confidentiality of subject documents and records, following the HIPAA rules
Clinical Staff Nurse/RN
Barnes Jewish Medical Center, St. Louis, MO June 2006 – June 2007
• Performed all duties as a Registered Nurse on a 24-bed medicine unit.
• Planned and implemented patient care for up to 9-10 seriously ill patients per shift in the hospital setting
• Responsible for the care and management of patients experiencing many different medical diagnoses including,
but not limited to the following: Congestive Heart Failure, Coronary Artery Disease, Arrhythmias, Atrial Fibrillation,
End Stage Renal Disease, Diabetes Mellitus, Gastrointestinal Diagnoses and HIV/AIDS
• Assess patient status and notified physician of any clinical changes
• Provided education and instruction to patients and their families on healthcare needs, medical diagnoses and
healthcare options
• Maintained confidentiality of patient records, following the HIPAA rules
Regional Clinical Research Associate II
Health Decisions, Chapel Hill, NC December 2005 – February 2007
Monitored a Phase III clinical trial in the therapeutic area of Alzheimer’s Disease
Administered protocol and related study training to assigned site personnel and established regular lines of
communication with site staff to manage ongoing project expect ations and issues
Visits sites to assess the qualification of potential investigative sites, initiate studies, instruct site personnel on the
proper conduct of studies, to review data and ensure data collected from start up to termination of studies and t o
terminate studies.
Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and
compliant with applicable local regulatory requirements and ICH guidelines.
Performs investigative site file reconciliation, requests any new or updated site-related essential and non-
essential documents and reviews them for content, consistency with other documents and compliance with
appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
Performs source document verification, retrieves case report forms (CRFs) and performs query resolution in a
timely manner and oversees drug accountability and safety at investigative sites.
Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information,
resolves queries and assists sites in completion of SAE reports.
Generates visit reports and letters for site and project management using study specific software
Maintained confidentiality of subject documents and records, following the HIPAA rules
Regional Clinical Research Associate II
PPD Development, Morrisville, NC April 2004 – December 2005
Monitored a Phase III clinical trial in the therapeutic area of Osteoporosis Prevention
Administered protocol and related study training to assigned site personnel and established regular lines of
communication with site staff to manage ongoing project expectations and issues
Visits sites to assess the qualification of potential investigativ e sites, initiate studies, instruct site personnel on the
proper conduct of studies, to review data and ensure data collected from start up to termination of studies and to
terminate studies.
Implements and monitors clinical trials to ensure sponsor and in vestigator obligations are being met and
compliant with applicable local regulatory requirements and ICH guidelines.
Performs investigative site file reconciliation, requests any new or updated site -related essential and non-
essential documents and reviews them for content, consistency with other documents and compliance with
appropriate local regulatory requirements, ICH guidelines, project SOPs and sponsor requirements.
Performs source document verification, retrieves case report forms (CRFs) and performs query resolution in a
timely manner and oversees drug accountability and safety at investigative sites.
Ensures Serious Adverse Event (SAE) reporting according to project specifications, reviews SAE information,
resolves queries and assists sites in completion of SAE reports.
Generates visit reports and letters for site and project management using study specific software
Maintained confidentiality of subject documents and records, following the HIPAA rules
EDUCATION
Bachelor of Science in Nursing, University of Texas at Arlington, Arlington, TX Currently Enrolled
Associate of Science in Nursing, J. Sargeant Reynolds Community College, Richmond, VA December 2001
CERTIFICATIONS
Registered Nurse (RN), NC-2002; MO-2005 (current); IL-2011
Basic Life Support (BLS), MO 2014
Advanced Cardiac Life Support (ACLS), MO 2008
SKILLS
Microsoft Office Suite (Word, Excel, PowerPoint, Project)
Electronic Data Capture (Medidata Rave, Inform, DataLabs)