Clinical Research Data
Resume:
Shawna M. Freeman
Manchester, NH 03103
**************@****.***
Professional Experience
PPD 07/2007 - 12/2009
Regional CRA II
. Monitoring Phases II through III.
. Monitoring the conduct of clinical trials, especially enrollment and
quality of data.
. Verifying subject safety and site adherence to FDA Regulations and
ICH/GCP Guidelines.
. Ensuring Adverse Events are reported appropriately, accurately and in a
timely manner and that follow-up activities are conducted as necessary.
. Reviewing CRF, Informed Consent Documents and query language/narratives.
. Acquiring specific clinical and therapeutic knowledge related to studies
monitored.
. Conducting Qualification, Initiation, Interim and Closeout monitoring
visits.
. Ensuring complete and thorough study drug reconciliation.
. Managing trip reports, letters, query resolutions and expenses.
. Managing site master file contents and working with sites to ensure
communication requirements between site and IRB are adhered to.
. Providing support and timely follow-up for all audit and quality
assurance activities.
Quintiles, Inc. 05/2006 - 06/2007
Clinical Research Associate
. Monitored Phases II through III.
. Organized and participate in investigator meetings and conducted site pre-
investigational visits.
. Conducted on-site clinical monitoring which include: document review,
ensuring accurate data recording, verifying patient data, adherence to
the protocol of a clinical trial, drug accountability in accordance with
good Clinical Practices (GCP), the Code of Federal Regulations (CFR), and
company SOPs.
. Conducted close out visits: review record retention requirements and
secure and review investigator's final report.
. Prepared trip reports, recommended corrective action where appropriate,
maintained regular telephone contact with sites, and maintained written
correspondence with site.
. Assisted in the collecting and tracking of regulatory documents.
Millennium 12/2003 - 04/2006
Clinical Research Associate
. Monitored Phases I through III.
. Coordinated the set up and monitoring of clinical studies which includes
pre study, initiation, ongoing monitoring and close out visits in
accordance with the protocol, SOPs, Good clinical Practice and ethical
guidelines.
. Performed pre trial visits to assess investigator suitability including
discussion of clinical data and protocol requirements and review of SOP's
as required.
. Prepared and submitted EC and RA applications for sites.
. Performed initiation visits to set up the study with the investigator and
site staff including any necessary training as required.
. Coordinated and performed regular monitoring visits to ensure only
eligible subjects were recruited into the study, data was consistent and
source documents were verified, and queries were resolved.
. Ensured all safety issues were being followed up and reported
appropriately.
Education
Mass Biotech Education Center (2007) Clinical Research
Certification
Barnett International (2006) Monitoring Clinical
Drug Studies
University of Massachusetts MS Accounting/BS Business
Admin. (2001)
References Available Upon Request
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