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| Job Title: |
In-House CRA |
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Job Category:
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Bioinformatics |
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Job description:
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Oncology Preferred -
Independently oversees the accomplishments of one or more protocols with multiple sites to ensure compliance with Good Clinical Practices (GCPs) and study protocols, including investigator selection, reviewing regulatory documents and preparing reports while meeting timelines/milestones and operating within budget.
Prepares study manuals, informed consent documents, regulatory binders, enrollment tracking reports, SOPs, final study report, etc.
Presents information and data at investigator meetings as needed.
Creates draft CRF Completion Guidelines.
Develops plan to assess slow-enrolling sites, identifying and resolving root problems.
Conducts site visits as required – pre-study, initiation, interim, and close-out visits including site visit reports.
Performs data review, when necessary, for accuracy and completeness.
May assist in the design of protocol and CRFs, writing of Investigators Brochures, generation of medical summaries and progress reports and preparation of INDs, NDAs, PLAs.
Field daily phone calls from sites and address issues in a timely manner.
Provides guidance and training for junior-level CRAs.
May function as Project Team Lead.
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Skills:
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BS in the life sciences or related; BSN a plus.
2+ years Field Monitoring experience with a CRO, Pharmaceutical or Biotech firm.
Recognized CRA Certification (ACRP or SoCRA) a plus.
Solid understand of all elements of Good Clinical Practices (GCPs).
Excellent communication skills.
Ability to prioritize work in order to meet demanding timelines.
Function effectively both independently and as a team member.
Prior project lead and/or supervisory experience a plus.
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Employment type:
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Salary Range:
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Unspecified |
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| Other Information |
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Degree:
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Bachelors |
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Experience (year):
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2 |
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Job Location:
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PA - PA - USA |
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Post Date:
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11/17/2008 |
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