Clinical Research Associate II (435113)
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POST DATE 9/13/2016
END DATE 10/11/2016
JOB DESCRIPTIONJob Description:
OVERVIEWResponsible for the conduct and management of post marketing commitment studies, focusing in the areas of protocol development, study planning and implementation, site monitoring and management, enrollment and data quality.Responsible for feasibility assessments for new studies.Manages TMF contents and responsible for TMF reconciliation.Responsible for the preparation of study documents (i.e., consent forms, site instructions, etc.).Responsible for the preparation of study training and investigator meeting materials and presents at study training workshops and investigator meetings.Responsible for the development and preparation of study start-up, maintenance, and close-out activities, including monitoring plan.Responsible for the adherence to timelines, study quality and SOPs for assigned studies.Coordinate and complete all operational activities required for the registry start-up, ongoing maintenance, and close-out of Medical Affair (MAF) registry programs.Monitoring of registry programs at sites according to the monitoring plan.Participate in the selection of CROs and other vendors as needed.Responsible for the preparing reports that outline registry progress for both internal and external customers.Partner with the MAF team members to anticipate/identify potential problems with registry activities and develop and implement corrective actions to ensure success with these activities.Guidance of registry specialist activities supporting MAF programs.Other duties as assigned. Skills: Ability to travel approximately 50% is required3 - 4 years experience as a CRA in biotechnology, pharmaceutical industry or CRO.Excellent organizational skillsStrong written and oral communication skillsStrong interpersonal skillsExperience in effectively managing multiple tasks and projectsAbility to self-motivate and work independently to meet timelines.Delegates work appropriatelyIndependently develops study documents and processesDemonstrated ability to monitor all visit types independently Understands the needs of stakeholders and able to develop action plansDiscerns urgency of issues and takes appropriate actionKnowledge of ICH & GCPs. Education:Bachelor's degree, preferable in biological sciences or related field.
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