CRA needed for Pharma Co in Branchburg, NJ.

Kelly Clinical Resources is seeking a CRA (Clinical Research Associate) for a contract position in Branchburg, NJ.

' Functions independently, and monitors one or more clinical investigations, including initiating and closing investigational centers and collecting, processing, and reviewing case report forms.
' Assists with the overall planning, development, and data management of one or more clinical investigations, including the preparation, writing, and completion of required documents.
' Has a thorough understanding of FDA, ICH, and GCP regulations, guidelines, policies and practices for conducting clinical investigations

Responsibilities:
' 70% travel may be required.
' May be the lead monitor of assigned protocols and/or projects.
' Schedules and performs the monitoring of one or more clinical investigational sites.
' Prepares and executes one or more clinical investigations (includes pre-study, initiation, interim, and close-out visits).
' Responsible for all aspects of study monitoring (completion of monitoring confirmation visit letters, trip reports, follow-up letters and study site payments) and also may co-monitor and audit the work of others.
' Participates in investigator site selection.
' Registers patients onto clinical investigations.
' Documents and maintains all site contacts on appropriate forms.
' Collects, processes, reviews, and makes corrections to case report forms.
' Initiates, reviews, and negotiates site budgets/contracts.
' Actively participates in clinical team meetings, leads discussions on assigned protocols.
' Aware of and follows company SOPs, GCPs, and ICH guidelines.
' Expenses travel receipts and handles corporate card reconciliation.
' Composes check requests and purchase orders.
' Reviews literature and attends conferences and courses.
' Interacts daily with appropriate individuals, departments, or contractors to support and maintain the clinical investigations.
' Prepares timely reports on the status of clinical investigations.
' Prepares clinical study supplies to be shipped to the investigational sites.
' Projects the usage of clinical supplies.
' Assists in the preparation and completion of IND, BLA, and NDA documents, as well as product annual reports and final safety reports.
' Designs/prepares case report forms.
' Participates in and may also be responsible for the organization of a Sponsor and Investigator Meeting.
' Trains and supervises less experienced staff or CRO personnel to ensure consistency and compliance in monitoring of clinical investigations. Indirectly supervises subordinate staff.
' Coordinates vendor/CRO services.
' Generates study specific monitoring plans and Informed Consent templates.
' Reviews tables, listings, and study reports for assigned protocols.
' Reviews, revises, develops SOPs.
' May participate in internal/external audits.
' May assist in updating of the Investigator's Brochure and final study reports for assigned protocols.

Requirements:
' Minimum of 3+ years of progressively increasing clinical research experience within the pharmaceutical industry.
' Experience in drug development, especially FDA regulations and GCPs or Associates of Clinical Pharmacology CRA certification.
' A minimum academic degree in Nursing (R.N. or B.S.N), Life Sciences (B.S. or B.A.), Pharmacy or Medicine. Experience requirements may be less with advanced degrees.
' Ability to resolve and make judgments regarding administrative, scientific and/or clinical problems under general supervision.
' Ability to prepare summary reports and deliver presentations which are clear, focused, and concise.
' Ability to indirectly supervise subordinate staff personnel



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Kelly Scientific Resources(KSR) is the scientific business unit of Kelly Services, a Fortune 500 staffing industry leader. We provide scientific staffing services on a temporary, project and full-time basis to a broad spectrum of industries including Pharmaceutical, Biomedical, and Clinical Research.Kelly Services is an Equal Opportunity EmployerContact?Information?:.925 Harvest Drive, Ste 100
Blue Bell?PA?19422