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Description: Our client, a specialty pharmaceutical
company serving the dental and dermatology markets,
currently seeks a CRA. The CRA is responsible for the
following duties: Initiates, monitors, and manages
Phase I, II, III, and IV clinical trials. Monitors,
and assists in recruiting clinical sites. Assists
in liaison activities between contracted research organizations,
field sites, investigators, study coordinators, pharmacists,
and staff members. Participates in pre-study and site
initiation planning. Monitors clinical and/or laboratory
data to ensure accuracy, thoroughness, and regulatory
compliance of clinical documentation. Ensures resolution
of data queries. Assists in providing technical assistance
to study sites regarding the conduct of clinical research.
Tracks data forms, reports, and documents necessary
for completion of clinical study, both in-house and
from participating study sites. Performs clinical
monitoring, site evaluation, and closeouts. Assures
delivery and shipment of drugs and products. Maintain
and track clinical studies budget. Assists in writing
FDA submissions. Act as liaison with Professional
Affairs, Regulatory Affairs, Manufacturing, Drug Development,
Research, Quality Assurance and Compliance and Accounts
Payable, to facilitate the dissemination of information
as appropriate.
You must possess excellent verbal and written communication and organizational skills and the ability to handle multiple projects and priorities. Working knowledge of Microsoft Office Suite including Microsoft Word, Excel, PowerPoint and Outlook is required.
REQUIREMENTS
BS degree and two (2) years pharmaceutical experience required.
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