Clinical Study Analyst - AZ

CLINICAL STUDYANALYST

 

B. McLaughlin Associates, Inc., a clinical research organization located in Phoenix, AZ is looking to hire a Clinical Study Analyst with strong regulatory experience.

Purpose

Provide operational support in order to meet Sponsor Study Management timelines

Key ResponsibilitiesParticipate in and contribute to meeting Sponsor Study Management timelines  Comply with standardization and best practices within organizationComplete administrative and study duties as requiredResolve routine requests, escalate complex requests; recognize underlying complex issues and communicate as appropriateProvide Sponsor systems support, as required Coordinatewith the clinical project team for the distribution, retrieval andreview of regulatory documents required for initiation of a clinicaltrialCollect, track, maintain andaudit required regulatory and clinical documents for study sites (i.e.,CVs, FDA 1572, Lab Certification, Financial Disclosure and Lab NormalsRanges, IRB documentation, etc.) throughout clinical trialsCommunicate with sites to ensure compliance and submission accuracyDirect contact with sites and all levels of Sponsor Study PersonnelRoutineinteraction with Principal Investigators, clinical site personnel andSponsor to ensure a smooth and consistent communication pathwayPrepare necessary and appropriate regulatory documents for submission to Sponsor and/or other entitiesEducation

Associates Degree or equivalent experience required.  Bachelors Degree preferred.

SkillsAdaptability,integrity, communication, teamwork, problem-solving, initiative,flexibility, detail-oriented, accountability, organized, able toprioritize.Strong oral and Written communication skills requiredStrong computer skills preferred, including Microsoft Office

Experience1-2 years or more comparable experienceExperience with the IND and pharmaceutical/medical device clinical trial processRequires an excellent working knowledge of the federal regulations, GCP and ICH guidelines.