Description
Working under very general supervision the qualified candidate will be responsible for overall clinical study management and communication of project status with management, including the following responsibilities:
Designing and developing investigational plans to meet IDE requirements
Conducting study start-up activities including identification,
recruitment and qualification of physicians/investigational sites, as
well as preparation /administration of required study documents,
including IRB submissions.
Monitoring and/or coordinate with contract monitors to ensure studies
are conducted in conformance with regulatory requirements (e.g., IDE,
IRB).
.Interpreting results of investigations in preparation for regulatory
submissions.
.Providing imaginative, thorough and practicable solutions to a wide
variety of difficult problems.
May interface with marketing or research project teams and government
regulatory agencies to provide technical consultation.
Requires a wide application of clinical research principals, theories
and concepts in the field plus working knowledge of other related
disciplines.
Keyword: Clinical Research Associate, Regional Clinical Research Associate, Regional Clinical Monitor, Clinical Monitor, CRA, Clinical Site Manager, Clinical Protocol Manager, Clinical Research Manager, Director Clinical Research, SR CRA, Sr. Clinical Research Associate, Senior Clinical Research Associate, Clinical Research Scientist
Requirements
min 4 years experience as a Clinical Research Associate (or equivalent position) in Pharmaceutical industry.
Detailed working knowledge of device Good Clinical Practices,
Strong ability to communicate clinical information (concepts and
results) in oral and written communication to experts (e.g., FDA
reviewers) and to product development team members (e.g., clinicians,
marketing personnel, engineers).
Strong organizational skills (e.g., able to manage multiple
institutions and/or projects).
Willing to travel up to 80%
Education Requirements
Minimum of a BS/BA in a scientific Discipline or similar.
Keywords:
Keyword: Clinical Research Associate, Regional Clinical Research Associate, Regional Clinical Monitor, Clinical Monitor, CRA, Clinical Site Manager, Clinical Protocol Manager, Clinical Research Manager, Director Clinical Research, SR CRA, Sr. Clinical Research Associate, Senior Clinical Research Associate, Clinical Research Scientist
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