Clinical Trial Assistant

Join Kelly FSP at our client site in Irvine, California!

This is a hybrid position onsite Tuesday, Thursday and every other Friday

• 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.

• Know, understand, incorporate, and comply with all applicable laws and regulations relating to business activities and Policies and Procedures of the Health Care Compliance Program and Code of Conduct.
• May be asked to provide additional support to Clinical Operations staff, as needed.

• Minimum of a Bachelor’s Degree is required.

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

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