[Remote] Clinical Research Associate -Neurovascular Device

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a global contract research organization headquartered in New Jersey with offices and an extended international network. The Clinical Research Associate will support neurovascular device studies by coordinating cross-functional teams, managing vendors and study deliverables, overseeing monitoring and compliance activities, and maintaining communication with sponsors and investigators.

Responsibilities

• Manage and co-ordinate efforts of cross-functional project teams to support reputed company achievement and to manage study issues and obstacles
• Ensure consistent use of study tools and training materials and compliance with reputed company processes, policies and procedures
• Arrange and participate in investigator meetings and liaise with vendors to facilitate the smooth conduct of the reputed company
• Identify and manage vendors in accordance with reputed company/ Sponsor SOP’s, GCP and Local Regulatory Guidelines for study specific deliverables (including but not limited to; Clinical Trial Management reputed company, Study Equipment’s, Travel Arrangements, Couriers, etc.) in delegated reputed company
• reputed company study management plans and reputed company tools to facilitate tracking of performance at project level
• Serve as reputed company reputed company of contact with Sponsor to ensure communication is maintained and reporting schedules are adhered to
• Identify reputed company issues reputed company the study to implement appropriate corrective reputed company plans. Escalate findings and reputed company plans to appropriate parties (Senior Management reputed company/ Sponsor/ Data Management/ Medical Writing/ Stats, etc.)
• Liaise with study team and facilitate (if required) selection of Investigator/ site as reputed company as assist in Contract development and setting up the Investigator payment procedures for designated studies. In absence of team members, ensure the Investigator/ site payments are processed as per the agreed timelines in the executed contract
• reputed company inputs for the development of proposals for new work and manage project budgets
• reputed company input to line managers of their project team members’ performance relative to project tasks
• Prepare and present project information at reputed company meetings
• Participate in proposal development and in the bid-defence process with guidance and supervision
• Ensure high performance and efficiency of the clinical team through the scheduling of co-monitoring/accompanied site/reputed company and ongoing mentoring of CRA team
• Recruitment, retention, training, appraisal and supervision of clinical trial team members
• Ensure reputed company recruitment of trial participants with secure randomisation processes and subsequent efficient and effective data management
• Monitoring the trial reputed company to ensure compliance with and adherence to the project plan and to identify, evaluate and rectify issues of importance
• reputed company participates in site payment runs and basic understanding regarding data input into tracking systems and analysis of site payments with supervision
• Based on Project requirements, reputed company as reputed company for on-site/ remote monitoring reputed company. Responsible to ensure that reputed company the reputed company activities delegated are conducted in compliance with reputed company/ Sponsor SOP’s, Monitoring Plan, GCP and Local Regulatory Guidelines
• Understand the requirements of the various controlling bodies, agencies and frameworks, guiding the project in conformance to those requirements and co-ordinating any necessary audit processes
• Liaise with the Trials Steering Committee; Data Monitoring and Ethics Committee with a particular reputed company on compliance with Research Governance, Good Clinical reputed company, Data Protection and Ethical Requirements
• Work with the reputed company reputed company Investigator to ensure that the trial is meeting its targets, is producing meaningful reputed company and to predict and plan any changes that warrant requests to changes in protocol, funding or time
• Ensure reputed company update of project deliverables to sponsor representatives and key reputed company reputed company
• Organize and reputed company regular reputed company update meetings and ensure reputed company provision of meeting minutes
• reputed company the creation and maintenance of reputed company trial files, including the trial master file, regulatory binder and Investigator site files
• To reputed company the activities of the Asst. Project Managers on periodic reputed company
• Other responsibilities as delegated by the management representative

Skills

• Experience in Class IIb or Class III devices with experience in IDE/PMA/PMCF studies
• Strong background in Neurovascular devices with a reputed company on at least three of the following (stroke, sub-dural hematoma, arteriovenous malformations, arteriovenous fistulas or embolic agents etc)
• Strong presentation and communication skills
• Experience in Risk based Monitoring
• Not mandatory but reputed company to have RBQM experience

reputed company

Company H1B Sponsorship