Clinical Study Administrator

Kelly Science, Engineering, Technology & Telecom; Irvine (CA); On-site; USD 42,000 - 64,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking an Administrative Support role within Clinical Operations in Irvine, CA. The position involves assisting project teams, tracking data, coordinating communications, and supporting regulatory activities.

The candidate should have a Bachelor's degree and at least one year of administrative experience, with clinical research exposure preferred and strong MS Office skills.

Qualifications

• Bachelor's degree required.
• 1 year of administrative support experience.
• Previous clinical research experience preferred.
• Knowledge of MS Office (Excel, Word, PowerPoint).

Responsibilities

• Track study data and follow up with clinical sites on essential documents.
• Assist in payments/tracking for patient reimbursements.
• Perform data entry in systems and run reports for management reviews.
• Support IRB/IEC renewal compliance and site/vendor coordination.
• Coordinate meetings and audit preparation; communicate with managers and team members.

Skills

Administrative support

Clinical research

MS Office

Data entry

Communication

Education

Bachelor's degree

Tools

MS Excel

MS Word

PowerPoint

Job description

Under direction of Clinical Operations personnel, and in accordance with all applicable Regional, state and local laws/regulations and corporate company 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.

Other Administrative Tasks:

• Know, understand, incorporate, and comply with all applicable laws and regulations relating to companies 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.

Job 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).

Additional Requirements:

• Demonstrated competencies in the following areas are required: