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Reference Letter-CRA-Joanna Wolinski (1)
1. 375 N. Stephanie St., Suite 1411
Henderson, Nevada
89014-8909
To whom it may concern
RE: Internship Curriculum of Clinical Research Professional Development Program, ICH GCP
Guidelines, Clinical Trial Monitoring and Research Site Coordination.
This is to confirm that Joanna Wolinski has successfully completed the 1 year Internship for the Clinical
Research Professional Development Program ICH GCP Guidelines, Clinical Trial Monitoring and
Research Site Coordination Program.
Over the course of the internship, Joanna performed Study Planning, Development and Study Conduct
activities, such as but not limited to:
Assisted/coordinated with protocol review.
Assisted with patient informed consent.
Evaluated and selected investigators (sites).
Assisted in overall development planning.
Designed and developed case report forms (CRFs).
Prepared and submit documents required to meet regulatory, GCP and SOP requirements.
Wrote and reviewed SOPs.
Wrote and reviewed protocol amendments.
Acted as the principle source of communication between the Study Sponsor, Clinical
Investigators and CRO.
As a member of the clinical group, communicated on study requirements and study progress with
colleagues and management, as well as liaise with other departments in CRO.
Joanna performed all these tasks competently and with commitment and enthusiasm. She has
demonstrated the ability to work under pressure and to plan and organize successfully to meet tight
deadlines. Her strong interpersonal and communication skills have allowed her to develop good working
relationships with both her colleagues and management.
Yours truly,
Jennifer Spencer
Jennifer Spencer
Project Manager