Title: Regional
Clinical Research Associate
Reference
Number: 33551
Location: DC/Baltimore; Louisville/Lexington, KY; or
| Monitor investigational sites within a territory to ensure both the quality and timeliness of clinical data. |
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Responsible
for the following activities during monitoring visits: ensure
patient safety by reviewing informed consents and adverse event
data; review clinical data for accuracy and completeness; resolve
source data discrepancies and data clarification forms (generated by
Data Management); assure adherence to the protocol, GCPs, and SOPs;
create action plans to address site related issues; review drug
accountability and compliance data; and review investigator study
files for required documents. |
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Participate
in the debriefing and follow-up process for any GCP audits conducted
at assigned clinical research sites.
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Responsible
for updating Management as necessary, by completing detailed
monitoring visit reports and telephone communications including, but
not limited to, site-related problems, resolutions, actions taken,
protocol deviations, study progress and enrollment
status. |
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Identify
potential investigators in designated region. Participate in the
initiation of new investigative sites or conduct solo initiations as
negotiated with the Study Teams. Ensure the proper training of site
personnel. |
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Participate
in
special projects and attend training sessions, regional meetings and
task forces as assigned by CRA Management. |
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This position requires 3+ years experience in a monitoring capacity. EDC experience is a plus, but not mandatory (all trials are done by EDC). A BS degree or RN (3+ years experience) is required (No Exceptions). Home office set up is a must. This position also requires Site Management skills, which include initiating payments, processing payments, regulatory document initiation and retrieval, enrollment management and also initiating drug accountability. |