Note: The job is a remote job and is open to candidates in USA. Kelly Science and Clinical FSP, a managed solution provider and business unit of Kelly Services, is seeking a Clinical Project Coordinator to support a medical device client remotely. The role provides clinical research operations and administrative support for clinical studies, including Trial Master File and Clinical Trial Management System management, study tracking, documentation, communications, and coordination of project activities.
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
- As directed, provides 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
- 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
- Responsible for ensuring 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
Skills
- Minimum of a Bachelor's Degree is required
- Requires previous administrative support experience or equivalent for at least 1 year
- Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point)
- Tracking
- Written and verbal communications
- Attention to details
- Organizational skills
- Previous clinical research experience preferred
- Clinical/medical background preferred
Benefits
- Remote opportunity
- Medical benefits
- Dental benefits
- Vision benefits
- 401K
- A variety of other benefits to choose from
- Paid time off, including holiday, vacation, and sick/personal time
Company Overview