Clinical Research Associate (CRA)

Department
部门

Title
职位

Clinical Research Associate

Start Time
任职时间

ASAP

Direct Report
直线经理

Elizabeth Lindner, Director Clinical Project Management

Direct Subordinates
直线下属

None

Primary Function
主要职能

A Clinical Research Associate will work closely with the Clinical Project Manager by providing support on assigned study tasks, which may include the responsibilities listed below.

Major Responsibilities and Duties
主要职责和任务

  • Oversees TMF set-up, maintenance, and quality control checks for assigned studies.
  • Maintains CTMS entry for assigned studies.
  • Assists Clinical Project Manager with study tasks including Site ID, Vendor ID, Vendor oversight, site payments, budget and financial management.
  • Review data issues with Clinical Sites and work to resolve and document resolution.
  • Develop site communications as needed, including newsletters and study wide communication notices, FAQs.
  • Assist with management and oversight of on-site monitoring activities.
  • Prepares and attends project team meetings and provide updates on project status and site-specific performance.
  • Maintains up to date information on the current competitive landscape of assigned compound and provides updates to the project team when new information is available.
  • Oversees study start-up and site management for assigned studies. Identifies areas requiring follow-up and improvement at each clinical study site and recommend and implement corrective action.
  • Assists in preparation for advisory board and investigator meetings and training materials; presents or assists in presentation.
  • Proactively identifies project issues and contributes to problem resolution.
  • Works collaboratively and effectively in a project team in both outsourced and internally managed clinical study environments.
  • Contributes to development of internal Clinical Operations systems to improve business processes.

Major Responsibilities and Duties
主要职责和任务

  • Oversees TMF set-up, maintenance, and quality control checks for assigned studies.
  • Maintains CTMS entry for assigned studies.
  • Assists Clinical Project Manager with study tasks including Site ID, Vendor ID, Vendor oversight, site payments, budget and financial management.
  • Review data issues with Clinical Sites and work to resolve and document resolution.
  • Develop site communications as needed, including newsletters and study wide communication notices, FAQs.
  • Assist with management and oversight of on-site monitoring activities.
  • Prepares and attends project team meetings and provide updates on project status and site-specific performance.
  • Maintains up to date information on the current competitive landscape of assigned compound and provides updates to the project team when new information is available.
  • Oversees study start-up and site management for assigned studies. Identifies areas requiring follow-up and improvement at each clinical study site and recommend and implement corrective action.
  • Assists in preparation for advisory board and investigator meetings and training materials; presents or assists in presentation.
  • Proactively identifies project issues and contributes to problem resolution.
  • Works collaboratively and effectively in a project team in both outsourced and internally managed clinical study environments.
  • Contributes to development of internal Clinical Operations systems to improve business processes.

Qualifications
资格要求

  • Life sciences or medical background is required.
  • At least 3 years experience in a function that can be related to pharmaceutical or medical development, preferred previous CTA or CRA experience.
  • Bachelors degree.
  • The ability to work with cross-functional teams in a matrix environment is a must.
  • Strong organizational and time management skills; detailed oriented.
  • Excellent interpersonal and communication skills.
  • Proficiency with Microsoft Outlook, Excel, Word, PowerPoint and Project.
  • Ability travel domestically globally up to 20 – 30% of time.