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.