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Clinical Research Associate
Job
i3 Pharma Resourcing
US
-
Thousand Oaks,
Thousand Oaks
Job Code - 23535
Position - FULL TIME
Job First Active on: Monday, October 26, 2009
APPLY TO THIS JOB (You will be applying directly to i3 Pharma Resourcing for this position!)
JOB DESCRIPTION: Clinical Research Associate
Major Position Activities & Responsibilities:
Responsible for the activities required to start up clinical trials including: protocol and CRF development; implementation; development of trial related documents and operational procedures; regulatory document collection and document filing.
Responsibilities include clinical investigational site recruitment, negotiation of Clinical Trial Agreements and grants, pre-study site evaluations, clinical investigational site monitoring, clinical investigational site closeout, clinical investigational site training, adverse event reporting, ensure that data collected is accurate and verifiable, resolution of clinical investigational site queries, ensure drug shipments and accountability, review site study files.
Additional responsibilities:
· Assist in the evaluation, selection and monitoring of contract research organizations and other vendors based on the scope of work and established performance metrics for the trial.
· Contribute to training of vendor staff as appropriate
· Independently monitor/co-monitor multiple investigational sites for therapeutic area in accordance with State and Federal regulations, Good Clinical Practice regulations and internal Standard Operating Procedures.
· Independently reviews Serious Adverse Event reports, and clinical study reports with associated study tables, listing and figures.
· Train and mentor junior level clinical research staff.
Minimum 2-3 years of clinical research experience, either CRO / Biotech or Pharmaceutical.
BA/ BS degree in Science or related field.
Medical/ Dental/ 401k
18 days vacation / paid Holidays
REQUIREMENTS - QUALIFICATIONS: Clinical Research Associate
See Information Above
I3
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