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Clinical Research Associate

Cambridge, MA 02142

Post Date: 07/10/2018 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

Demeika is known for her enthusiasm in working closely with hiring managers to assess their needs, creatively solve problems, and passionately help candidates find their “perfect fit” dream jobs.

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