Clinical Project Coordinator Kelly Science and Clinical FSP is currently seeking a Clinical Project Coordinator for a remote opportunity supporting our Medical Device client. This person will join our Kelly FSP (Functional Service Provider) division, a managed solution provider and business unit of Kelly Services, Inc. This role is full-time and is offering full benefit options. As a Kelly FSP employee you will be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You will also be eligible for paid time off, including holiday, vacation, and sick/personal time.
Summary: This individual will provide support to the clinical study staff
Perform 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.
Key Job Activities: - 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.
Education: Minimum of a Bachelor's Degree is required.
Experience Previous clinical research experience preferred
Requires previous administrative support experience or equivalent for at least 1 year.
Clinical/medical background preferred
Knowledge Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point). Demonstrated competencies in the following areas are required:
Tracking
Written and verbal communications
Attention to details
Organizational skills
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