Clinical Study Administrator

Clinical Study Administrator

Location: Irvine, CA (Hybrid)

Overview: 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.

• Support project teams: track study data, follow up with clinical sites on essential documents, draft and distribute study mailings and newsletters, draft agenda/meeting minutes and schedule meetings.
• Assist in payments/tracking for patient reimbursements.
• Perform data entry in systems.
• Run reports including training matrix reports and 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 investigational devices and site binders, maintain master device accountability log.
• Assist with scheduling and organizing investigators and expert panel meetings.
• Assist with file reviews and audit preparation.
• Ensure 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, 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.

• Experience and knowledge working with computer systems (Microsoft Office – Excel, Word and Power Point).

Associate

Full-time

Administrative, Project Management, and Other

Pharmaceutical Manufacturing and Staffing and Recruiting