Clinical Project Coordinator

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

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability.

As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.