Manager Clinical Research
Resume:
Kelley Holsinger, M.A.
Clinical Research Associate, Independent Consultant
Wake Forest, NC
***********@*******.***
OBJECTIVE
I am an independent consultant seeking a regional Clinical Research Associate contract monitoring pharmaceutical,
biologics, or medical device trials.
EDUCATION
M.A. Experimental Psychology, 2005
Radford University; Radford, VA
B.A. Psychology, 2003
Edinboro University of Pennsylvania; Edinboro, PA
GENERAL SKILLS AND QUALIFICATIONS
• Consistently ensures the well being and safety of study participants
• Excellent oral and written communication skills
• Able to build quality interpersonal relationships
• Sound knowledge of scientific methods, GCPs and regulations relating to clinical research
• Working knowledge of computer technology and its application to the clinical environment
• Ability to prioritize workload and meet deadlines
• A self-starter, can work efficiently on own initiative or can integrate easily into team environment
THERAPEUTIC EXPERIENCE
Role Therapeutic Area Indication
CRA CNS Multiple Sclerosis
CRA Gastroenterology IBS-d
CRA Infectious Disease Influenza
CRA Infectious Disease Respiratory Viruses
CRA Oncology Bladder Cancer, Colorectal Cancer
CRA Women’s Health Contraceptives, Secondary Amenorrhea
Study Manager Dermatology Patch and cream testing
Sr. CTA CNS Multiple Sclerosis, Neuropathic Pain
Study Coordinator CNS ADHD
MONITORING SKILLS AND QUALIFICATIONS
• Work remotely from home office as regional CRA for 3 years
• Conduct monitoring tasks in accordance with the approved monitoring plan including: evaluation, pre-
study/selection, initiation, interim and close out visits
• Assess potential study sites to insure the facility, staff and patient population are sufficient for study conduct
• Initiate clinical trial sites according to the relevant procedures to ensure compliance with the protocol,
regulatory and ICH/GCP obligations
• Conduct source document verification to ensure accuracy of CRF entries in relation to patient records
• Conduct regulatory review and manage the essential documents, as required by local regulations and
ICH/GCP
• Assess investigational product accountability via physical inventory and records review
• Write Informed Consent Forms and review for required elements
• Review site advertisements and subject material in preparation for IRB and sponsor review
• Ensure Adverse Event and Serious Adverse Event (SAE) reporting according to regulatory specifications
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• Document observations in reports and letters and consistently submit trip reports prior to designated timelines
with few required revisions
• Escalate observed deficiencies and issues to clinical management expeditiously and follow all issues through
to resolution.
• Perform trial close out and retrieval of trial materials
• Facilitate effective communication between investigative sites, the client and the project team through written,
oral and/or electronic contacts
PROFESSIONAL EXPERIENCE
Clinical Research Associate
kjhResearch, LLC; Home Based in Wake Forest, NC
June 2014 - present
• Independent consultant monitoring clinical trials
• Conduct monitoring tasks in accordance with the approved monitoring plan including: evaluation, pre-
study/selection, initiation, interim and close out visits
Clinical Research Associate
Health Decisions; Home Based in Wake Forest, NC
November 2012 – June 2014
• Lead CRA monitoring a Bladder Cancer Study and responsible for 11 sites
• Monitor for Colorectal Cancer, Upper Respiratory Infection, Woman's Health Contraceptives and Secondary
Amenorrhea trials
• Participate in the process improvement sessions to discuss upgrading business procedures and SOP review
• Conduct monitoring tasks in accordance with the approved monitoring plan including: evaluation, pre-
study/selection, initiation, interim and close out visits
Clinical Research Associate
PPD; Home Based in Raleigh, NC
March 2012 - November 2012
• Monitored the site selection, initiation and interim visits for 2 large scale IBS-d trials, responsible for 18 sites
• Developed various monitoring tools, study documents/forms and forecasting tools
• Conduct monitoring tasks in accordance with the approved monitoring plan including: evaluation, pre-
study/selection, initiation, interim and close out visits
Clinical Study Manager
Hill Top Research, Derm Rx (Pharmaceutical Division); St. Petersburg, FL
June 2011 – March 2012
• Managed a team of study coordinators and research assistants in a dermatology research clinic
• Oversaw the conduct of Vasoconstriction, Cumulative Irritation Assessments and Repeat Insult Patch clinical trials
• Wrote protocols and designed study methodology
• Developed SOPs, training programs and other work procedures
Clinical Research Associate
PPD; Home Based in Tampa, FL
June 2010 – June 2011
• Received monitoring training through PPD’s Clinical Foundation Program
• Monitored initiation, interim and close out visits for two large scale Influenza Vaccine trials
• Monitored interim visits for a Multiple Sclerosis trial responsible for 16 sites as well as initiation visits for the
extension trial
• Identified scientific misconduct, collected evidence, documented the findings and escalated per SOP; presented
these findings to the FDA
Sr. Clinical Trial Assistant
Quintiles, Inc; Research Triangle Park, NC and San Diego, CA
June 2008 – June 2010
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• Assigned to Multiple Sclerosis, Neuropathic Pain and Non-Small Cell Lung Cancer trials
• Conducted in-house monitoring as well as co-monitoring onsite visits
• Acted as a central contact between the clinical team and sites
• Updated and maintained clinical systems that track site compliance and performance
• Conducted regulatory review of the Trial Master File for accuracy and completeness
• Completed investigational product accountability
• Reviewed and monitored case report forms (CRFs), issuing queries and reviewing edit checks
• Participated in the preparation and presentation of Investigator Meetings
• Facilitated weekly team and client teleconferences to provide regular study updates and pertinent clinical
issues
Research Associate/Site Start Up
INC Research; Raleigh, NC
March 2008 – June 2008
• Assigned to various Oncology trials
• Guided sites through the start up process
• Responsible for the collection and review of regulatory documents for drug release
Clinical Research Coordinator
Duke University ADHD Program; Durham, NC
March 2007 – March 2008
• Conducted recruitment, screening and scheduling of research participants
• Facilitated the IRB submission process and maintenance of approvals for local IRB
• Administered consent and cognitive assessments to enrolled participants
• Served as a Sub-Investigator conducting behavioral ratings and documented observations
• Obtained biological samples and processed labs
• Supervised ordering and dispensing of investigational drug
• Managed Case Report Forms, queries and clinical data
• Communicated with monitors to review data and follow up on issues identified during visits
• Maintained inventory of supplies and equipment required for execution of research protocol
• Provided updates to the sponsor regarding study progress and participant enrollment
• Trained study staff on protocol and cognitive assessment measures
Survey Methodologist
RTI International; Research Triangle Park, NC
August 2005 – March 2007
• Projects included a national survey on drug use and health, religious beliefs and practices and a
comparative study on consumer choice of mattresses vs. a body mapping instrument
• Designed and evaluated methodological studies
• Documented findings in reports and presentations
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