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Permanent - In-House CRA

New Jersey All, New Jersey

Post Date: 03/30/2017 Job ID: JN -032017-18721 Industry: Clinical Operations - Clinical
In-House Senior CRA
  • Serves as support to the Clinical Research Manager (CRM) thought the conduct of the study
  • Participate in the planning of a study or multiple studies with the CRM
  • Perform operation and administrative duties assigned by the CRM
  • Assist with the CRO selection process and ensure contractual obligations are met
  • Assist the CRM with site study budget negotiations and payments
  • Assist CRM with Vendor identification and selection and payments vis a vis contractual agreements
  • Contribute to development of a payment schedule section for Vendors and process/obtain approval from management
  • Assist the CRM as a lead CRA to study start up, study execution and close out activities
  • Assist in the development and coordination of protocols and informed consent forms
  • Assist in the planning and coordinating investigation meetings
  • Prepare and present protocol and general study-related presentation to field monitors, investigations and adequately informed of protocol requirements, standard operating procedures and monitoring procedures
  • Review data in the electronic data capture system; enter and reconcile queries as necessary; assist in trend review
  • Participate in the development of site reference materials
  • Monitor site preparation, including sending regulatory document packages to sites
  • Assist the sites in obtaining the required forms and passwords for all electronic systems
  • Prepare training materials related to monitoring practices and procedures to be presented at monitor training meetings to ensure that the monitors are adequately informed of monitoring requirements and procedures
  • Review site qualification monitoring visit reports to assess site eligibility to participate in the study
  • Review monitoring reports throughout the study to ensure that sites are adhering to the protocol and to identify potential issues and propose solutions
  • Track and report on monitoring activities
  • Assist the CRM in CRO in vendor management, including independently holding meetings to identify and resolve issues
  • Maintain open lines of communication
  • Monitor ongoing progress of enrollment and other benchmarks at the investigative sites to assess adherence to the study protocol and timelines
  • Maintain internal tracking systems, including budgets and expenditures
  • Mentor CRA s regarding regulatory accuracy and set-up of the Trial Master File
  • Perform operation and administrative duties assigned by the CRM
  • Mentoring junior CRAs
  • Ensure that conduct of all studies follow local or global SOPs and regulatory requirements
Requirements:
  • A minimum of a bachelor's degree is required
  • A minimum of 5 years of experience in Clinical Research is required
  • Global experience is a plus
  • Must have experience with site qualification, initiation, regular monitoring and site close-out visits
  • People Management experience is required
  • Demonstrates an understanding of regulatory requirements including a working knowledge of FDA GCP and ICH guidelines
  • Must have knowledge of EDC system
  • Must have good written and verbal skills to communicate effectively with investigators and departmental personnel about protocol related topics
  • Must be able to present reports and updates at Project and Staff meetings (PowerPoint)
  • Ability to make independent decisions for CRM back up
  • Must possess strong technical skills and include a working knowledge of Microsoft Office




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