Kendle looking for Clinical Research Associate - I - Wilmington, North Carolina - USA
Kendle International Inc. (Nasdaq: KNDL) is a leading global clinical research organization providing the full range of early- to late-stage clinical development services for the world's biopharmaceutical industry. Our focus is on innovative solutions that reduce cycle times for our customers and accelerate the delivery of life-enhancing products to market for the benefit of patients worldwide.
As one of the world’s largest global providers of Phase I-IV services, we offer experience spanning more than 100 countries, along with industry-leading patient access and retention capabilities and broad therapeutic expertise, to meet our customers' clinical development challenges.
Post: Clinical Research Associate - I
• Acts as site liaison to develop and maintain rapport with study site personnel, vendors, sponsors and INC Research team members.
• Assists with the development of materials for and performs regulatory document collection and tracking (where applicable), technical support, pre-study, study initiation, monitoring, site management, and close-out activities via telephone while adhering to all applicable regulatory and Standard Operating Procedures (SOPs) and Project Plans.
• Performs in-house site support activities, researching and responding to various site inquiries (study materials, protocol, systems use, study documents, CRF conventions, queries, payments, etc.), appropriately tracking and documenting these interactions.
• Assists in the development of and maintains study documents such as CRFs and CRF completion guidelines, mailing/faxing materials, newsletters and telephone scripts
• Participates in the preparation and coordination of investigator meetings or other investigator site training and attends investigator meetings as requested.
• Performs quality control (QC) activities across all areas of project responsibilities.
• Adheres to safety reporting requirements
• Adheres to a schedule of project-related communications (e.g., calls, mailings, reports) and activities and effectively employs technology for tracking.
• Attends and presents PCS status at project team and client meetings as requested
• Establishes working relationships with other INC Research personnel to ensure that study-specific documentation is retrieved, filed and maintained in a high quality, timely quality manner.
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