• Assist withAdministration of clinical research projects: recruiting, investigators,collecting investigator documentation, site management, site monitoring,preparing status reports and completing other technical tasks tocompletion.
• Initiate,monitor and close-out clinical investigative sites under supervision fromProject Managers, Clinical Regulatory Managers, and Medical Directors.
• Provideongoing assistance and education of investigational sites in principles of GoodClinical Practice (GCP) as it relates to Research involving human subjects.
• Ensuresubject safety through diligent monitoring of the site’s compliance with studyprotocols and the collection of adverse event information
• Update,track and maintain study specific trial management tools/system.
• Monitor CaseReport Forms (CRF) for missing implausible data. Assess compliance with study drug handlingprocedures. Ensure that all adverse events are collected pursuant to GCP.
• Report,write narratives and follow-up on reported serious adverse experiences.
• Assist withgeneration and reconciliation of queries to investigation sites to resolveproblem data.
• Assist andmanage project budget and investigator site budget, attend project teammeetings, plan and attend investigator meetings, and communicate with clients.
• Generate andtrack drug shipments and storage.
• Providecoverage to clinical contact telephone lines. Provide answers to common protocol related questions under thesupervision of the Project Manager and Medical Director.
Bachelor’s degree required. Preferred degree in the Biological / HealthSciences. Pharmaceutical industryexperience a plus.
Minimum 1 year experience in Drug Development,Regulatory Affairs, CRA experience a plus. Dialysis, Rheumatology, Oncology, Cardiology, Pediatrics or GIexperience preferred
Ability to travel up to 80%, including overnight
Strong multi-tasking abilities and able successfullyhandle multiple priorities simultaneously. Detail oriented, self-motivated
Proficiency in MS Word, Excel and Outlook. Knowledge ofMedical/Regulatory Terminology
We are an Equal Opportunity Employer and all qualifiedapplicants will receive consideration for employment without regard to race,color, religion, sex, national origin, disability status, protected veteranstatus, or any other characteristic protected by law.