Job Description

Clinical Study Administrator

Summary:

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:

• 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.

Qualifications:

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).

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