Lead Clinical Research Associate
: Job Details :

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.Job DescriptionTitle: Lead Clinical Research AssociateLocation: Raritan, NJ 08869Responsibilities:LEAD CLINICAL RESEARCH ASSOCIATE:Under supervision of Clinical Project Lead, oversees performance of assigned field monitors and site activities in accordance with the Monitoring Plan, Protocol, Good Clinical Practice (GCP), ICH guidelines and federal regulations.The LCRA acts as a primary liaison between Field Based CRAs and the Clinical Project Lead (CPL).Additional responsibilities include: Implementation of enrollment and recruitment strategiesAssistance in vendors' selection processesDevelopment, execution, management and compliance assurance of the Monitoring PlanReview and approve trip reports, track scheduling, report submission metrics, site deviations and action itemsOversight of monitoring visit scheduling, site and monitoring performance metrics, issue escalation and corrective actionsDevelopment of training materials and study tools for site and CRA useAssistance in formation of the Adjudication Committee including oversight of documentation collection and filing into the Trial Master File QualificationsQualifications: BS/BA, MS is desirable5+ years of site management of which a minimum of 2 years field monitoring experienceKnowledge of applicable standards and regulations for clinical trialProven oral and written communication skillsProven planning skills; ability to create and track detailed project plansProven interpersonal, leadership, organizational and effective time management skillsAbility to work independently and within a cross-functional team environment to identify and escalate site/monitoring related activities issues to the management team in a timely fashionExperience in Cardiovascular Therapeutic area #J-18808-Ljbffr