Clinical Research Associate

Integrated Resources, Inc is a premier staffing firm recognized as one of the tri-states most well-respected professional specialty firms. IRI has built its reputation on excellent service and integrity since its inception in 1996. Our mission centers on delivering only the best quality talent, the first time and every time. We provide quality resources in four specialty areas: Information Technology (IT), Clinical Research, Rehabilitation Therapy and Nursing.

· __The in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the Clinical Project Manager(s). ____

__· __The CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager. ____

__· __The CRA performs work within established protocols under general supervision.____

__· __Assists the study team(s) to deliver the clinical study within agreed timelines.____

__· __Assists in authoring/contributing to clinical study documents and study related plans developed by Clinical CROs and vendors. (E.g. Clinical Trial Insurance, IWRS specs, Lab Manual, Licensing Agreements etc.) Provides oversight of Clinical CRO Investigator background checks.____

__· __Assists in oversight of vendor shipment of clinical supplies (e.g. lab kits, test machines, equipment etc.) being sent to sites prior to initiation as necessary.____

__· __Provides oversight of Essential Documents for Investigational Medicine Release as per relevant SOP.____

__· __Reviews Clinical Monitoring Reports and correspondence related to restudy and Initiation Visits and follows up with Clinical CRO to resolve open action items.____

__· __Manages escalation of study related issues and communicates as appropriate with Clinical Project Manager.____

__· __Responsible for the operational oversight of the Clinical CRO with regards to data feed setup in the Clinical Trial Management System.____

__· __Assists and/or participates in planning and conduct of Investigator’s Meetings as necessary.____

__· __Assists Clinical Project Manager in tracking study related activities which are not appropriate to be outsourced.____

__· __Reviews a percentage of monitoring visit reports for oversight and escalates issues to Clinical Project Manager.____

__· __Assists with agenda distribution & minute taking for internal clinical study team meetings where formal documentation is needed and the Clinical CRO is not present.____

__· __Provides oversight of Clinical CRO activities regarding amendments to confidentiality and site agreements.____

__· __Assists study team with preparation for audits/inspections Reviews clinical close out monitoring visit reports for oversight and escalates issues to the Clinical Project Manager.____

__· __Liaises with Transparency group to ensure Clintrials.gov is updated.

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Feel free to forward my email to your friends/colleagues who might be available.

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Thanks,

Warm Regards,

Kavita Kumari

Integrated Resources, Inc.

Direct: (732) - 844 8725