Project Manager Quality Assurance
Resume:
TIFFANY RICKS BLAKENEY
Apt E205
Durham, North Carolina 27713
***************@*******.***
Skills: Project Management Certification, Contract/Proposal Writing, Data Management
Pharmaceutical Library Research, SAE Reporting, Electronic Data Capture Systems
(InForm System by Phase Forward, eTrial, RAVE, Medidata) Trial Watch, Nottingham
CTMS, IVRS, Microsoft Office Package, Cardiac Device, Tumor Measurements,
Creation team for WebEDC User Guide, Laboratory Tracking User Guide, Protocol
Manual of Operating Procedures,
Experience: EMMES Corporation Rockville, MD
Lead Clinical Research Associate 11/10 - Present
Participates in the preparation and review of draft protocol and informed consent documents.
Coordinates with project team and other study personnel to determine data collection
requirements based on protocol and to test electronic case report forms. Reviews,
contributes to, and processes project documents and required reports, such as study
protocol documents and consent forms, SAE and protocol deviation reports, accrual and
other study status and/or study web site reports. Contributes to project-specific site
initiation activities, tracks readiness status of sites for study initiation, (e.g., submission of
essential documents, writes and distributes corresponding internal reports). Conducts site
assessments, including site activation, interim monitoring and close-out visits. Writes and
distributes site visit reports within established timelines, and tracks resolution outstanding
issues. Collects reviews and maintains regulatory documents. Review includes assessment
of completeness and compliance with regulatory requirements. Generates queries, produces
and distributes anomaly reports and resolves data discrepancies. Coordinates with project
statistician to develop and produce project-specific reports. Demonstrates understanding of
project and corporate SOPs by producing work in compliance with the SOPs. Conducts
training sessions for site personnel on GCP, study protocol requirements, EMMES data
systems and data management practices. Participates in internal audits and other project
and corporate quality assurance activities. Indications include Premature Infants
(Infectious Disease) Phase I, Central Nervous System (Stroke) Phase III
CLINSYS CLINICAL Bedminster, NJ
Senior Clinical Research Associate (Home-based) 03/08 – 03/10
Led as a Patient Recruitment Specialist for a high enrolling, large patient population global
trial. Involved in many aspects of the clinical trials including, participating in CRF,
protocol and SOP development and review, instruct and train necessary site personnel,
collect, analyze, and record clinical data, prepare necessary reports, coordinate clinical trial
activities with internal and external (CRO) personnel and more. Conducted trial initiation,
interim and close-out visits. Monitored site performance and compliance and provide
management with necessary reports, updates and recommendations. Interact with all
internal personnel involved with clinical trials; Clinical Study Managers, other CRAs,
Regulatory Affairs, Quality Assurance, Medical Writers, Statisticians, Data Management as
necessary. Trained and mentored Junior CRAs. Indications included: Seasonal Allergy
Rhinitis (Allergy), Ejection Fraction (Cardiology) Acute Coronary Syndrome Phase II b
(Cardiology, Cardiac Vascular Closure Device, In-patient), ADHF with Hyponatremia
Phase III b (Cardiology, In-Patient) Adolescents with Psoriasis Phase II (Dermatology),
Infectious Disease/HIV Phase II b, Cancer Pain (Oncology) Phase IV
COVANCE INCORPORATED - CONTRACT Princeton, NJ
Senior Clinical Research Associate (Home-based) 03/07 – 02/08
Conducted site visits to perform source document verification, protocol compliance, regulatory
compliance, drug accountability in accordance with GCPs and company SOPs. Identified
qualified investigators to conduct trials, including evaluation and conduct of pre-study site
visits. Asked to assist in vendor evaluation audits. SAE Reporting Follow-up. Indications
included: Gastro-intestinal/ Obstructive Bowel Dysfunction Phase III,
Cardiovascular/Atherothrombotic Ischemic Events (Cardiology, Inpatient/Outpatient)
Phase III, Central Nervous System(Epilepsy) Phase I, Renal(Renal Failure) Phase III
KENDLE INTERNATIONAL - CONTRACT Cincinnati, OH
Senior Clinical Research Associate (Home-based) 12/05 – 2/07
Completed project activities associated with monitoring functions of Phase III clinical
research study while continuing to develop knowledge of the drug development process,
Good Clinical Practices, and relevant regulations. Provided clinical and technical support
for CRA I, CRA II and administrative staff. Performed management of study site activities
to ensure the integrity of clinical data, in adherence to all applicable regulatory guidelines
and Standard Operating Procedures (SOPs) and Project Specific Operating Procedures
(PSOPs). Indication included: Rheumatology (Gout) Phase III
CHILTERN INTERNATIONAL Austin, TX
Regional Clinical Research Associate (Home-based) 6/04 – 11/05
Produced Case Report Forms, identified investigator sites, organized investigator meetings,
maintained site files, trial master files and study documentation, prepared and conducted
initiation visits, interim visits and termination visits, worked within timelines and budget
restrictions, tracked clinical trial supplies, tracked patient recruitment, produced status
reports, tracked SAEs, conducted study close-out activities, worked within SOPs,
conducted query resolution, and all other duties associated with monitoring and managing
EDC trials. Indications included: Cardiology (Hypertension) Phase II,
(Women’s Health) In Vitro Device
PHARMALINK Durham, NC
Clinical Research Associate (Office-based) 6/03 – 6/04
Participated in the investigator recruitment process and performed initial qualification visits
of potential investigators to evaluate the capability of the site to successfully manage and
conduct the clinical study. Obtained and reviewed documentation (regulatory) for
successful implementation, monitoring, and evaluation of clinical trials; works with sites to
obtain regulatory (IRB/EC) approval of study specific documents. Performed study
initiation activities, reviewing with the site personnel the protocol, regulatory issues, the
study procedures, and conduct training on completion of the CRF/eCRF. Reviewed case
report forms for completeness, clarity, legibility, conformity to available source
documentation, and adherence to the protocol. Performed study monitoring and closeout
visits per PharmaLinkFHI standard operating procedures to ensure that FDA regulations,
good clinical practices, and protocol requirements are being followed at the investigative
site. Assisted in preparation of protocols, case report forms, study manuals, and other
related documents, as requested by Clinical Lead. Indications included: Cardiology
(Angina) Phase II, Cardiology Heart Failure Registry (CRT Pacing Device)
PHOENIX DATA SYSTEMS - CONTRACT Durham, NC
Clinical Research Associate (Home-based) 10/02 to 6/03
Monitored activities at clinical study sites to assure adherence to (GCP) (SOPs) and study
protocols. Reviewed regulatory documents as required and prepared site visit reports.
Clinical Study Design – Reviews Case Report Forms and ensure they are complete,
accurate and verifiable. Contributed to the Case Report Form design. Participated in the
selection of investigators. Assisted in the execution of investigator contracts. Prepared
study start-up documents including 1572s CVs, Amendments, Investigators Study Files,
Enrollment Logs, etc. Prepared site-specific logs and investigator study files. Provided
feedback to the on issues pertaining to the standard CRF modules. Participated in
presenting, planning, preparation of Investigator Meetings. Assisted in the development of
patient recruitment strategy. Organized and performed; pre-qualification visits, site
initiations visits, regular monitoring visits, second reviews. Indications included: Oncology
(Breast) Phase I, II, Cardiology (Compensated Heart Failure – Stent Device) Phase III
BAYER CROPSCIENCE - CONTRACT Research Triangle Park, NC
Business Management Analyst 3/02 to 10/02
Analyzed the market share penetration and profitability of the product portfolio for: corn,
rice and wheat fields through skilled market analysis and segmentation to clearly identify
growth opportunities. Developed integration letter for BioScience Department
announcements concerning newly formed company to all seed company partners.
PAREXEL - CONTRACT Research Triangle Park, NC
Investigator Contract Analyst 12/00 to 2/02
Wrote/amended legal language in contracts between pharmaceutical companies and the
Principal Investigators commissioned to run clinical trials. Began clinical trial contract
initiation process; forwarded draft Clinical Agreement. Tracked site requested changes and
maintained constant communication with pharmaceutical company for approval and
contract language change. Managed budget negotiations within parameters of
pharmaceutical companies “per subject” budget. Created letters of indemnification that
were site and study specific. Transformed weekly database reports into spreadsheet for
Sponsor company; which provided status of contract in negotiation. Provided sound
business/regulatory/compliance advice and guidance to principal investigators regarding
business development, contract performance, risk avoidance/mitigation and problem
resolution. Indications included: Medical Device for Colon Cancer, Pediatric Asthma
GLAXOSMITHKLINE - CONTRACT Research Triangle Park, NC
Clinical Research Associate 12/98 to 12/00
Monitored activities at clinical studies to assure adherence to Good Clinical Practices
(GCPs), SOPs, and study protocols. Reviewed regulatory documents as required and
prepare site visit reports. Responsible for multiple projects. Often participated in the study
development and start-up process including reviewing protocols, designing and/or
reviewing CRFs, prepared Informed Consent forms, developed study documents,
organizing and presenting at investigator meetings, working with management on
monitoring strategy, and/or developing project-specific CRA training. Indications
included: Oncology (Prostate) Phase II, Respiratory (Asthma) Phase III, CNS
(Alzheimer’s) Phase III, Cardiology (Angina-Inpatients) Phase II, Infectious Disease (HIV)
Phase II
GLAXOSMITHKLINE - CONTRACT Research Triangle Park, NC
Clinical Submissions Assistant 4/97 to 12/98
Contributed to clinical study reports and New Drug Applications (NDAs) other regulatory
submissions as assigned; ensured compliance with company Standard Operating
Procedures and appropriate clinical and company wide policies. Documented information
on serious adverse events and reporting of events to pharmaceutical sponsor/FDA, writing
safety narratives, maintenance of adverse event database and safety review of patient
clinical data. Management of multiple protocols concerning in-house monitoring, tracking
of clinical data and preparation of study specific documents according to FDA regulations
and procedures.
Education: NORTH CAROLINA CENTRAL UNIVERSITY Durham, NC
Bachelor of Science – Political Science & Life Sciences May 1991
UNIVERSITY OF NORTH CAROLINA Chapel Hill, NC
Completed One Year of Law School September 1993
VILLANOVA UNIVERSITY Villanova, PA
Project Management Certification May 2002
References: Sarah R. Connell, Lead CRA (CLINSYS)
158 Duchess Court
Florissant, MO 63034
*********@*******.***
Jacqueline Duncan, Global Project Manager (CLINSYS)
6740 Autumn Oaks Drive
Brentwood, TN 37027
***************@*****.***
Carol Babby, CRA Manager (CLINSYS)
1815 Oak St.
Wilmington, DE 19805
*****.*****@*******.***
Dwelia Smith (COVANCE)
93 Rhonda Circle
Cordovia, TN 38018
***********@*******.***
Jennie Wong, RN, CCRP, Study Coordinator (TEMPLE UNIVERSITY)
Temple University
3401 N. Broad Street
3rd Floor Suite 320
Phila., Pa 19140
******@****.******.***
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