Principal Clinical Research Associate

Roche Diagnostics, U.S. with headquarters in Indianapolis, Indiana,
is looking for a Principal Clinical Research Associate. When you
choose to join Roche Diagnostics, the undisputed leader in
diagnostics, you will be working with a community of people who make
a difference by transforming the way patients are diagnosed and
treated. We are innovating Health Information, which leads to better
decisions, treatment and patient health. For more information about
Roche Diagnostics in the U.S., please visit
( http://www.roche-diagnostics.us/ ) www.roche-diagnostics.us or
( http://www.roche.us/ ) www.roche.us.



In this position, the Principal Clinical Research Associate is
responsible under minimal supervision for the global development of
study plans and protocols for complex human clinical research of in
vitro diagnostic device studies required to enter new products into
the marketplace in compliance with state and federal regulations and
corporate policies. The need to effectively manage multiple clinical
sites (5-10) or provide extensive oversight to a managing CRO
assuring accurate and timely completion of studies, including
adherence to timelines and budgets is required. Additionally, the
position will be involved in the monitoring of case report forms, for
trends in safety, efficacy, and adherence to the protocol. At the
conclusion of the studies, the candidate is responsible to ensure
availability of all final study data and report generation in support
of regulatory submissions (510(k), PMA, DeNovo).



Minimum requirements include a Bachelor's Degree in Clinical
Chemistry, Medical Technology, or related scientific field with 8
years of Clinical Chemistry and/or Clinical Trials experience.
Advanced degree, ACRP and/or SOCRA certification highly desired.
Qualified candidates should have demonstrated formal leadership
experience, knowledge in product testing methods and regulatory
validation; knowledge of statistical analysis used by regulatory
agencies, laboratories or professional organizations; knowledge of
GMP/GLP, safety, ISO, etc, with the ability to manage multiple
priorities and deliverables. Demonstrated experience in researching
literature, determining study designs, and determining study
endpoints is essential.
REQUIREMENTS
8 years Clinical Chemistry/Clinical Trials experience