Project Management
Resume:
Keisha Griffiths
Sayreville, NJ 08872
Phone: 732-***-****
Email: *************@*****.***
Objective To work as an intricate part of a team to provide insight along with assistance based on
my knowledge & experience.
Skills
15 years administrative experience supporting senior management
7 years experience within project management
Service & customer quality orientated
Outstanding communication skills, both orally & written
Able to manage & motivate myself & others
Collaborative & energetic, practical, dedicated, proactive, decisive & fair
Excellent client-facing consultancy skills.
Sufficient in Staff Training & Development
Ability to Coordinate Meetings, Meeting Minutes
Experience in MS Word, Excel, Outlook, Publisher, & Power Point
Skilled in maintaining executive calendars, setting travel arrangements & competing expense reports
Competent in Business Administration & Management
Work Experience
RPS, Fort Washington, Pennsylvania Sep 2013 - Present
Assigned to Sanofi-aventis as Senior Clinical Project Assistant
Ensure the delivery of high quality clinical trial support in a timely fashion.
Understand, prioritize & support clinical trial metrics.
Facilitate teamwork between departments & outside facilities.
Document site communications as required.
Point of contact for incoming site communications.
Process site personnel travel expense reports.
Request reimbursement of site personnel expenses.
Collect & coordinate completion of study documents
Order CRFs for Can office (sample) & sites' specific, or follow up on site's training for use of
electronic CRFs.
Order central lab supplies, & other study supplies.
Verify with sites to ensure all materials were received & that the site is ready for the initiation visit.
Update key dates & study team roster in study management databases.
Preparation & review of presentations to be used for the initiation visit.
Prepare scientific study tools (study coordinator handbooks, visit schedulers, dose calculator, etc)
upon needs.
Provide regular status updates to the team.
Run enrollment reports.
Verify that study documents are correctly filed in electronic repository.
Track status of study documents.
Ensure that site communications are sent & received by Records Management (in coordination
with study file management team as appropriate).
Support site audits (file management).
Interact with sites, clinical team, CRAs & other study team personnel to resolve issues with study
documents including missing documents, incomplete documents, misfiled documents, etc.
Reconcile payments schedule, ensure accuracy & completeness.
Ensure electronic study management tool reflects when site is closed (completed patients, event
dates).
QC & approve Grant payments.
Track & reconcile payments.
Read & respond diligently to internal & external correspondence.
Submit all required reports duly completed & on time.
Make certain that all confidential information is h&led as per company SOP's
BioClinica (formerly CoreLab Partners), Princeton, New Jersey Jan 2012 – Sep 2013
Project Leader
Reviews protocols, raw data forms & other study specific paperwork to assist the study team in
the appropriate implementation of clinical operations & to ensure accurate data collection & recording.
Coordinates the initiation & implementation of assigned clinical trials.
Coordinates & directs the appropriate & timely imaging QA & reads for assigned clinical trials.
Assists the radiologist, project assistant & project coordinator in imaging QA & reads as required.
Knowledgeable about medical & research terminology.
Records raw data (source documents, CRFs, etc).
Enters, maintains & tracks data in the computer databases.
Frequent liaisons with sponsor, contract research organizations (CRO) & investigator sites staff.
Identifies issues & contacts sites & sponsors for issue resolution.
Ensures confidentiality of study protocols & subjects is maintained.
Participates in sponsor site visits & audits as requested.
Interacts with all customers appropriately & professionally.
Communicates effectively, verbally & in writing, with all internal & external customers (physicians,
investigators, study coordinators, CROs, sponsors, coworkers, etc.)
Reports study needs & issues to the Manager, Clinical Operations.
Collaborates with management to resolve technical/radiological/study concerns & problems.
Identifies & participates in the performance improvement process.
Participates in the development, review & evaluation of SOPs & study specific procedures.
Responsible for managing team members work schedule.
Responsible for training & developing team members.
Covance, Princeton, New Jersey Feb 2006 – Jan 2012
Clinical Research Assistant
Acted as a contact for project team, client & study sites
Assisted with generation & reconciliation of queries to investigative sites/clients to resolve
problem data
Assisted with the management of study supplies & organize shipments
Created, updated, tracked & maintained study-specific trial management files, tools, & systems.
Assisted the local project team members with other administrative activities as required (e.g.
payments to investigators, correspondence with clients, preparation of status reports, & organization
of investigators’ meetings)
Co-ordinated meetings with clients, investigators, & project team, including taking minutes
Maintained administrative systems (tracking & other) for clinical projects
Trained & mentored project team members
Provided clerical support to project team (e.g., word processing, proofreading & editing
correspondence, large & small documents, mailings, shipment of study files, fax & photocopy
documents, assemble study documents, & arrange meetings, etc.).
Set up & maintained paper & electronic files & documentations.
Prepared project-related documents & other materials for delivery to archives, at appropriate
intervals.
Data entry & maintenance of selected study tracking data.
Assisted with coordinating & managing vendors.
Assisted/prepared for client or internal audits
Provided telephone coverage & related support duties.
Prepared & conducted mass mailings
Formed project & action plans
Supported senior management with expense reports, calendar maintenance, & international
travel arrangements.
Contributed to various Six Sigma initiatives
Trivue Entertainment, Watchung, NJ Apr 2005 - Feb 2006
Office Manager
Created client contracts and proposals
Processed accounts payable & receivables
Responsible for processing weekly & monthly payroll
Customer & client service via phone & email
Shipments of products & company media brochure kits
Organized tracking system for all tasks & documents
Tracked office spending and budgets / Maintained reports
Therapeutic Area Experience
Phase III Cardiovascular
Phase I, II, III Oncology
Phase III Central Nervous System
Phase III Infectious Disease
Education
University of Phoenix, Phoenix, Arizona
Bachelors of Science in Business Management, 2011
University of Phoenix, Phoenix, Arizona
Associates in Business Administration, 2008
The Cittone Institute, Edison, NJ
Certified Medical Administrative Assistant, 2005
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