Management
Resume:
Joyce L. Alston, BSc
*** ******* ***** **** *** *08
Durham, NC 27713
**********@*******.***
EDUCATION
Master of Public Administration with an Emphasis in Health Care Management,
Grand Canyon University, Phoenix, Arizona
In Progress, Expected Graduation June 2014
Bachelors of Science in Business Organizational Management, St. Augustine's
College Raleigh, North Carolina
Graduated: MAY/ 2003
Associate of Applied Science in Legal Secretarial Science, Vance Granville
Community College, Henderson, North Carolina
Graduated: JUNE/1991
Warren County High School, Warrenton, NC High School Diploma
Graduated: SEPT/1983-JUNE/1985
WORK HISTORY
PRA International, Raleigh, NC
December 2011- June 2012 Title: In House - CRA II
. Performs investigative site recruitment/feasibility, essential
document collection and review, clinical status tracking, and in-house
site management activities to ensure these activities are conducted in
accordance with the client and PRA protocol, standard operating
procedures (SOPs), ICH-GCP, and all applicable regulatory
requirements.
. Performs Investigator Evaluation and Recruitment for patient
Enrollment
. Ensure patients Informed Consents are reviewed and signed prior to IP
administration.
. Evaluate and document regulatory requirements related to
verification/validation
. Coordinates with Principal Investigator and central administration to
help ensure that clinical research and related activities are
performed in accordance with Federal regulations and university,
hospital and sponsoring agency policies and procedures.
. Assists the PI in development of materials and tools necessary to
appropriately train individuals involved in the conduct of the study
around issues related to (but not limited to) protocol requirements,
schedule of visits, execution of research plan.
. Cooperates with University and sponsoring agency compliance and
monitoring efforts related to human research participant protection
and reports instances of noncompliance to the appropriate compliance
office.
. Performs Essential Document Collection, Review, Maintenance and Close
Out activities
. Provides clinical status information to team members and project
management under guidance of Lead CRA/Clinical Team Lead/
Quintiles Inc via Aerotek, Morrisville, NC
October 2010-December 2011 Title: Clinical Trials Associate - Study
Start Up
. Assists Principal Investigator to assure that all key personnel or
persons 'engaged' in the research project have met training
requirements in accordance with Federal regulations and University and
sponsoring agency policies and procedures.
. Cooperates with sites for compliance and monitoring efforts related to
sponsored program administration and reports instances of
noncompliance to the appropriate compliance office. Coordinates and
facilitates monitoring and auditing visits. Notifies appropriate
institutional officials of external audits by FDA and sponsors.
. Collaborates with PI and institution to respond to any audit findings
and implement approved recommendations.
. Track, Review and Reconcile with iCRA's and CRA's to ensure all
documentation for 92 assigned sites are collected in accordance with
the site and investigator contract, study protocol and federal
guidelines.
. Review and approve country specific ICFs (if necessary);
. Prepare and distribute clinical site agreement and notice letters on a
country level;
. Collect and compile regulatory documents in collaborations with the
iCRA and CRA; Submit safety updates to
. IRB/IEC (if applicable);
BD Diagnostics, TriPath
Durham, NC
June 2008-October 2010 Title: Clinical and Research Trials Assistant
. Review and collection of patients Informed Consents prior to IP
administration
. On-site and In-house monitoring responsibilities including, collection
and verification of source documents, CA-125, imaging reports,
pathology, cytology reports.
. Collaborates with the PI to prepare IRB/HRPO and any other regulatory
submission documents as required by the protocol.
. Provide solutions to variety of technical problems of moderate scope,
examples include, inclusion and exclusion criteria for patient
enrollment.
. Extract pertinent information from all study documents such as
protocols and guidance for industry standards;
. Ensure patients Informed Consents are reviewed and signed prior to IP
administration.
. Evaluate and document regulatory requirements related to
verification/validation
. Prepares other study materials as requested by the PI. These study
materials include, but are not limited to, the informed consent
document, case report forms (CRFs), enrollment logs, and drug/device
accountability logs.
. Establishes and organizes study files, including but not limited to,
regulatory binders, study specific source documentation and other
materials
Bayer Healthcare/Talecris Biotherapuetics, Research Triangle Park, NC
JAN/2003 - JAN/2007 Title: Sr. Clinical Research Administrative
Assistant
. Providing updates to the SAE Access Database from Error Correction
Reports, Data Collection Forms, Update Request Forms and Adverse
Events
. Managed and maintained drug shipment IMPACT database to track and
inventory of study clinical supplies.
. Generate, resolve and track queries using Oracle based system, IMPACT
during data review activities and apply proper modification /
correction to the database
. Perform discrepancy management activities as needed, based on output
generated from the batch validation specifications.
. Contacts are with patients, family members providers, clinical nurses,
nursing department head, corps staff, respiratory staff and clerical
staff.
. Ongoing maintenance and reporting, exchange of information
. Research literature, articles and publications for all therapeutic
approvals and circulation of publications
. Member of Clinical Project Team; responsible for coordinating and
minute taking at all project team meetings
. Manage contracts, including CDA's, MSA, Amendments and Final Executed
Contracts.
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