Quality Assurance Technician
Resume:
Amanda Wyeth Grant, CCRP
Arlington, MA 02474
************@*****.***
PROFESSIONAL EXPERIENCE
Dana-Farber Cancer Institute, Boston, MA
Clinical Research Specialist, 2012 - 2013
. Managed multiple investigator-initiated clinical trials ensuring
accordance with GCP, institutional policies and procedures, and
research protocols
. Assisted in amending protocol and informed consent documents
. Liaised with investigators, disease groups, and supporting
pharmaceutical companies on conducting investigator-initiated
clinical trials
. Prepared and managed regulatory applications and reports regarding
the status of ongoing trials to federal and local agencies (DSMC
reports, FDA annual reports, etc)
. Led regular all-site teleconferences with investigators and study
teams to ensure that compliance was maintained
. Conducted SIVs (via WebEx) and activated sites into investigator-
initiated clinical trials
Harvard Clinical Research Institute, Boston, MA
Regulatory Documents Coordinator, 2009 - 2012
. Provided assistance during site selection and study start-up
. Collected, reviewed, and approved regulatory documents for
inclusion in the Trial Master File
. Developed and maintained databases for tracking regulatory
documents, work flow processes, and other essential trial related
documents
. Participated in on-site monitoring visits
. Provided centralized site support, communication, and coordination
to assure accurate and timely completion of all contracted
activities
. Served as the Site Management department representative for the
HCRI Regulatory Sub-Committee and organized the department's
regulatory meetings and resources
Vertex Pharmaceuticals, Cambridge, MA
Clinical Trial Coordinator, 2008 - 2009
. Prepared and revised documents including: protocols, informed
consent forms, case report form completion guidelines, and charters
for data monitoring committees
. Collected, organized, and prepared regulatory documents for
transfer to the Trial Master File
. Developed and maintained tracking tools to manage the start-up and
maintenance phases of a pivotal clinical trial
. Coordinated multi-departmental project meetings; prepared and
distributed agendas and meeting minutes
INC Research, Raleigh, NC
Research Associate, 2006 - 2008
. Ensured compliance with regulatory guidelines and study procedures
on all assigned clinical trials
. Maintained timely and effective communication with Project
Managers, Clinical Research Associates, and study sites
. Collected, reviewed, and filed essential regulatory documents for
the Trial Master File per Sponsor requirements
. Assisted with the development and maintenance of tracking tools for
regulatory documents, study drug, enrollment, query review, and
other study-related information
North Carolina State University, Raleigh, NC
Research Technician III/Laboratory Manager, 2004 - 2006
. Participated in laboratory research pertaining to the study of
innate immunology in zebrafish
. Managed laboratory organization and operation in accordance with
safety regulations and supervised undergraduate assistants
Weill Medical College of Cornell University, New York, NY
Senior Research Technician, 2002 - 2004
. Participated in the initiation of a preclinical trial for a
treatment for Batten disease, a fatal inherited pediatric disorder
of the nervous system, as a member of the Gene Therapy Core
Facility
. Produced adeno-associated gene transfer vectors in accordance with
Good Laboratory Practice, and set quality assurance and regulatory
guidelines
Dana-Farber Cancer Institute, Boston, MA
Senior Research Technician, 2000 - 2002
. Participated in projects pertaining to the study of Neuroblastoma,
a pediatric disease in which cancer cells form in nerve of the
adrenal gland, neck, chest, or spinal cord, and apoptosis in
developing zebrafish
. Provided general lab support (prepared solutions, ordered supplies,
maintained zebrafish colony, etc.)
Massachusetts General Hospital, Boston, MA
Research Technician, 1999 - 2000
. Member of the Zebrafish Mapping Core Group which worked to create a
3000-marker zebrafish genetic linkage map
. Provided support for the lab's positional cloning efforts
VOLUNTEER EXPERIENCE
Pan-Massachusetts Challenge
Volunteer Registration Team Leader
2008 - present
EDUCATION
Northeastern University, Boston, MA
Graduate-level courses including: Introduction to Drug and Medical Device
Regulation, Human Experimentation, and Validating & Auditing Clinical
Trials (2011-2012)
Boston College Continuing Education, Brighton, MA
Clinical Research Certificate, 2011
Harvard Extension School, Cambridge, MA
Graduate-level courses including: Developmental Biology, Introduction to
Statistics (2001)
Colgate University, Hamilton, NY
BA Biology, 1999
COMPUTER SKILLS
Proficient in Microsoft Word, PowerPoint, Excel, Outlook, BioClinica
OnPoint CTMS, WebEx. Knowledge of Adobe Photoshop, Microsoft Project,
PhaseForward EDC.
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