Clinical Study Administrator

Kelly Science and Clinical FSP is currently seeking a Clinical Study Administrator for a long-term engagement in Irvine, CA with one of our Global Medical Device clients. 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 may be eligible for Medical, Dental, Vision, 401K and a variety of other benefits to choose from. You may also be eligible for paid time off, including holiday, vacation, and sick/personal time.

Clinical Study Administrator
Hybrid - Onsite in Irvine, CA - Tuesday, Thursday and every other Friday

This individual will provide support to the clinical study staff within Clinical Operations
Perform a variety of clinical research operations duties of a routine and technical nature in support of clinical trials.

Supports project managers within the assigned clinical studies.

Key Job Activities:
Under direction of Clinical Operations personnel, and in accordance with all applicable Regional, state and local laws/regulations and corporate Johnson & Johnson procedures and guidelines, this position will
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 payments/tracking for patient reimbursements.
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
Is 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.
May be involved in other tasks to support Clinical Operations and Operating Company as needed.

Education
Minimum of a Bachelor's Degree is required.

Experience
Previous clinical research experience
Requires previous administrative support experience or equivalent for at least 1 year.
Clinical/medical background

Knowledge
Requires experience and knowledge working with computer systems (Microsoft office - Excel, Word and Power Point).

Additional Requirements
Demonstrated competencies in the following areas are required:
Tracking
Written and verbal communications
Attention to details
Organizational skills