Whitney Knight is seeking a position in clinical research to utilize experience in clinical trial monitoring, quality assurance, and FDA regulations. She has over 5 years of experience as a Clinical Research Associate and Clinical Trials Assistant conducting monitoring visits, building relationships with investigators, training site staff, and ensuring protocol and regulatory compliance. She has therapeutic expertise in oncology and rheumatoid arthritis from her involvement in clinical trials in these areas.

1. Whitney Knight
(919)-649-3252 Cell ●wdknight86@gmail.com
Seeking a position in clinical research to utilize ICHGCP certification, protocol compliance, and CFRtitle 21. Background
experience in following SOPs, cGMP, cGLP, and FDA regulations through work experience in the pharmaceutical
manufacturing industry. Direct experience conducting quality assuranceaudits,peer-subordinatetraining and task
management. Proven team player, goal and detail oriented, result driven, managed over 60 coworkers.
T HERAPEUTIC AREA EXPERT ISE:
Experience in Oncology and Rheumatoid Arthritis.
Indication Phase # Patients # Sites Countries
Breast
Cancer
III 154 7 4 US
Rheumatoid
Arthritis
I 190 7 8 US, Canada, New
Zealand
Rheumatoid
Arthritis
III 108 49 US, Canada, New
Zealand
PROFESSIONAL EXPERIENCE:
In-House CRA,PAREXEL,Durham,NC
May 2014 - Present
 Built relationship with investigatorsand site staff
 Conduct general site contacts in accordanceto the study specific Monitoring Plan, which may include:
 Review recruitmentplan and enrollment updates
 Follow-up on appropriatesite related questions
 Address/resolve issuespending from the previous visit
 Address protocol questions
 Check on site staff assignment
 Assess drug/study supply status
 Request outstanding documents
 Review site payment status
 Assist with query resolution
 Follow-up on data entry,query status and SAEs
 Generate contact reports in accordance with departmental timelines
 Supply sites with Site Regulatory Packet
 Ensure documents in the Site Regulatory Packet are completeper SOPs, GCP guidelines, and ICF completion
guidelines
 Conduct visits (qualification, initiation, monitoring,termination), ifapplicable
 Collaboratewith CRA on site issues/actions
 Perform regular reviews ofsite level data (e.g. CTMS, EDC, IVRS, ISIS) and ensure timely and high quality data
entry compliance from sites
 Train site team members on study specific tasks
 Support sites with drug / supply issues
 Responsible for the follow up on CF QC findings
 Update all relevant tracking systems on an ongoing basis
 Maintain site staff details in CTMS
 Collect updated/amended regulatory documents in collaboration with CRA and CTS as needed
 Provide collected documents to ROA for tracking, coding, scanning and uploading to WIP/sending to study
mailbox,where possible
 Create and distribute study document with support ofROA, as applicable

2.  Inform responsible COL of work status regularly
 Complete routine administrativetasks in a timely manner (e.g. timesheets, metrics)
 Maintain a working knowledge and ensurecompliance with applicable ICH-GCP Guidelines, local regulatory
requirements and PAREXEL SOP and study specific procedure (e.g. Monitoring Plan)
 Keep manager informed about work progress and any issues.Requires someinteraction / supervision by Manager
and assigned mentor, ifassigned.
Clinical trials Assistant,Quintiles,Durham,NC
November 2013 –May 2014
 Updated and maintained clinical trial management systems (CTMS) that track site compliance and performance
within project timelines.
 Prepared, handled, distributed, filed, and archived clinical documentation and reports according to the scope of
work and standard operating procedures.
 Updated, conserved, and conducted periodic review ofinvestigatorsite study files and clinical site files for
completeness across several protocols.
 Performed review ofessential regulatory documents required for study maintenance and closure.
 Assisted sites with ethics submission to institutional review board.
 Collaborated with Clinical Project Mangers on the preparation, handling, distribution, filing, and archiving of
clinical documentation and reports according to the scope ofwork
 Assisted with the tracking and management ofCase Report Forms, queries and clinical dataflow
 Acted as a remote site contact and a central contact for clinical team in designatedproject communications
Principal,Customer Service/Quality Assurance SpecialistW. Knight & Associates,Remote
August 2008 –November2013
 Prepared, handled, and distributedclientpolicy changes and concerns to agents
 Filed and archivedboth paper and e-documents to maintain business records
 Updated and maintained transactions and clientprofiles
 Reviewed reports,call records, and spreadsheets for accuracy and completeness
 Wrote case reports and completed liveforms to report problems to client in order to resolve and/or avoid issues
 Followed up with customers to ensure resolution ofcomplaints
 Maintained customerrelationships and satisfaction in high stress/interruption work environments
Pharmacy Technician,CVSPharmacy,Smithfield,North Carolina
September 2007 –August 2008
 Worked closely with Pharmacistto fill physician’s prescriptions/orders for 100s ofpatients per week
 Complied with HIPPA Privacy law
 Maintained patient records and other documentation for 100s ofpatients per week
T echnician II,Wyeth Vaccines,Sanford,North Carolina
September 2006 –February 2007
 Recorded information on Batch Production Records (BPRs) and other controlled documents daily
 Operated manufacturing and laboratory equipment;autoclaves,chromatography columns, pHmeters, UV
spectrometer, steam in place (SIP) and clean in place (CIP) systems, fumigation hoods, centrifugation systems
 Visually examined product to ensure consistency in volume concentration and color, and exclusion offoreign
particles and cloudiness
Clarification Operator,T alecris (Belcan),Clayton,North Carolina
May 2005 –September 2006
 Issued and bonded Batch Production Records (BPRs) and other batch record documents for 12 to 14 pools of
blood plasma per work.
 Reviewed Batch Production Records (BPRs) for accuracy and completeness to lower departmental errors
 Troubleshot production equipmentand used problem solving to ensure production deadlines were met
EDUCAT ION:
North Carolina State University, Raleigh, NC, B.Sc. in Human Biology, 2013