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In-House CRA Lexington United States,  

Shire (company)


Posted on : 19 October 2018

Project Description

the in-house Clinical Research Associate (CRA) is responsible for providing support for day to day clinical study activities under general supervision of the the clinical Project Manager(s). the CRA also provides support for existing departmental tasks and may take on developmental tasks as appropriate upon discussions with manager.  the CRA performs work within established protocols under general supervision.

responsibilities

40% – study start up

  • facilitate cda & contract execution process (routing and tracking of study specific contracts)
  • manage study specific po creation
  • collaborate with study manager and CRO to ensure accurate study specific CTMS setup and data feeds
  • liaise with transparency group to ensure clintrials.gov is updated accordingly
  • participate in creation and distribution of sponsor specific study aides/materials and communications
  • key point person for r&d select background checks
  • collate documents required for the ec/irb/ha submissions

20% – study maintenance

  • assist clinical study manager in tracking study related activities which are not appropriate to be outsourced
  • agenda distribution & minute taking for internal study team meetings
  • support susar distribution
  • maintain internal & external contacts lists in CTMS
  • facilitate contract execution & study related po creation for any change orders

15% – study close out

  • assist study team with preparation for audits/inspections
  • assist study team in close out in CTMS
  • liaise with transparency group to ensure clintrials.gov and results are updated/distributed accordingly

25% –  departmental tasks

  • maintain knowledge and act as team super user for related systems (e.g. CTMS, r&d select, po creation, SharePoint)
  • maintain up to date Training record attending internal/external Training as necessary
  • participate in inter-departmental workgroups to create or enhance processes
  • take on Career developmental activities/tasks as necessary

    

Education and experience requirements

  • bachelor’s degree required
  • 1-3 year’s experience in similar/relevant field (eg. sponsor, CRO, Clinical Trial vendor, clinical Coordinator, etc.)

key skills, abilities, and competencies

  • relevant experience in clinical research or related field
  • adequate Good Clinical Practice Training
  • general knowledge of regulatory requirements and guidelines governing clinical research
  • comfortable with technology and ability to learn new systems quickly
  • strong knowledge of ms word, Excel, PowerPoint and outlook
  • requires strong attention to detail in composing and proofing materials, establishing priorities, scheduling, and meeting deadlines
  • must be able to professionally interact and communicate with visitors, vendors, and individuals at all levels of the organization
  • must be able to work in a fast paced environment with demonstrated ability to manage multiple competing tasks and demands
  • ability to work successfully within a cross-functional team
  • understanding how their input and role coordinate more effective business practices for shire’s Clinical Development business and commitment to the culture, vision, and mission of shire

complexity and Problem Solving

  • ability to take ownership and manage tasks as well as communicate effectively
  • ability to lead others to drive deliverables forward            
  • must be able to work in a fast paced environment
  • demonstrate ability to prioritize multiple competing tasks
  • ability to work with minimal supervision and complete tasks according to deadlines

internal and external contacts

  •  internal: clinical programs support, clinical programs, clinical Medicine, clinical processes & optimization, biometrics, Data Management, Pharmacovigilance and clinical supplies
  • external: CRO, clinical investigators, and consultants

other job requirements

  •         available for up to 10% domestic and/or international travel

Locations

, Lexington, MA, US

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