Clinical Project Coordinator

About the Role

This individual will provide support to the clinical study staff by performing a variety of clinical research operations duties of a routine and technical nature in support of clinical trials. This includes tracking study documents and management of the Trial Master File (v-TMF). Supports project managers within the assigned clinical studies.

Responsibilities

• Accountable for tracking essential documents and ensuring completeness of the v-TMF.
• Assist study staff and Administrative Clinical Study Administrators (aCSA) to quickly resolve issues relating to the v-TMF.
• Identifies problems and assists in implementing corrective and preventive actions.
• Manages and supports ongoing use of the Clinical Trial Management System (CTMS) and tracking study milestones and activities.
• Provide safety documentation to other functional groups in support of safety committee meetings as requested.
• Provide support to the project teams, which may include:
  • Tracking study data
  • Following-up with clinical sites on essential documents
  • Assist in drafting and distributing study mailings, including study newsletters
  • Assist in drafting of agenda/meeting minutes and scheduling of meetings
  • Assist in providing internal communication of important clinical data and events
• Assist with tracking site payments.
• Performs data entry in systems and run reports including training matrix reports, metrics for management reviews.
• Support management of IRB/IEC renewal compliance.
• Coordinate process for the review of study data, such as MRIs, by third-party vendors.
• Assist in ordering, shipping, tracking of study supplies including, but not limited to, investigational devices and site binders.
• Maintain master device accountability log as requested.
• Assist with scheduling and organizing investigators and expert panel meetings.
• Assist with file reviews and Audit preparation.
• Ensure appropriate level of communication with managers, project leaders, and team members.
• Work with management group to help achieve department goals.
• Participate in process improvement activities within the department, including process improvement activities related to the v-TMF/CTMS.
• May be involved in other tasks to support the Scientific Affairs Clinical department and Operating Company as needed.

Requirements

• Minimum of a Bachelor’s Degree is required.
• Previous clinical research experience preferred.
• Requires previous administrative support experience or equivalent for at least 1 year.
• Clinical/medical background preferred.

Skills

• Experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and PowerPoint).
• Demonstrated competencies in the following areas:
  • Tracking
  • Written and verbal communications
  • Attention to details
  • Organizational skills

Benefits

• Full benefit options including Medical, Dental, and Vision.
• 401K and a variety of other benefits to choose from.
• Paid time off, including holiday, vacation, and sick/personal time.

This role is full-time and remote, supporting a Medical Device client through Kelly FSP (Functional Service Provider) division.