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Clinical Research Associate

Cambridge, Massachusetts 02142

Post Date: 05/17/2018 Job ID: 1950 Job Category: Clinical: Clinical Operations and Development

Join our clients Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy approach. Reporting to a Sr. Clinical Trial Manager of Clinical Development Operations, you will be responsible for supporting two global Phase 3 clinical studies. In this role you will be a key team member who will effectively organize and assist in the implementation, management and close-out of the Phase 3 clinical trials to support Regulatory filings, with a focus on inspection readiness.

Job Responsibilities:
  • Provide overall program support to the CDO team as well as liaise with other internal and external collaborators to execute on bluebird’ s clinical studies
  • Assist with the QC review and creation of site and monitoring related trial documentation (e.g., consent forms, study manuals/forms, training materials, monitoring plans)
  • Assist with the development of CRA and site training materials and ensure all study metric trackers, contact lists, checklists and systems are up to date
  • Track clinical data entry expectations against timelines, including data cuts as appropriate
  • Assist with the oversight of vendors including CROs, Central Labs and independent contractors; actively participate in development of study manuals
  • Responsible for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready for filings
  • Communicate with CROs and/or study sites to support accurate completion, retrieval and review of all regulatory documents and site status/contact information
  • Perform monitoring oversight visits both independently and as a co-monitor to oversee the contracted CRA including site initiation, routine monitoring and close-out visits in accordance with monitoring plans
  • Oversee site compliance with study protocols, GCP/ICH, applicable regulations prior to, during and following visits.
  • Work with site personnel and study team to resolve issues as needed
  • Play key role in the review of study specific data review, including tables, listings and figures
  • Plan and organize study related meetings; take detailed notes at meetings on decisions and action items and distribute the list to the team in the form of minutes
  • Know the stage of all study activities and communicate details to ensure that all team members are kept informed and aware of action items that will impact their tasks
  • Review a percentage of monitoring visit reports as outlined in the monitoring plan and escalates any issues identified to the Clinical Trial Manager
  • Track progress of enrollment, deviations and data entry for assigned sites and across the study; assess trends in effort to communicate issues/resolutions to the broader study teams
  • Acts as liaison between different ancillary groups in the creation of documents when communicating with resource providers outside the project team
  • Participate in the development and review of SOPs, Work Instructions and Administrative References
  • 10-25% travel may be required


Qualifications:
  • BA/BS in a life science or nursing preferred, with at least 3 years of experience in clinical operations, working in the biopharmaceutical or CRO industries, and previous monitoring experience
  • Proficiency in the entire Windows Suite (MS-Project a plus)
  • Experience with eTMF and Quality Management Systems - Veeva experience preferred
  • Solid working knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical and experience in both US and EU/ex-US studies a plus
  • Prior experience supporting Regulatory filings and inspections and audits desirable
  • Demonstrates a drive for solutions, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressure
  • Ability to foster relationships with vendors, clinical sites and colleagues based on trust and collaboration
  • The ability to support several projects simultaneously, an adaptive working style and a creative and thoughtful approach to problem solving
  • Thrives in a fast-paced and evolving environment
  • Independently motivated and able to manage multiple projects with minimal supervision to deliver on time and with high quality
  • Excellent and transparent communication skills and ability to influence across multiple functions
  • Positive, outgoing and collaborative attitude with a passion for helping patients using innovative science
  • Be ready to embrace the principles of the culture

Demeika Roberts

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