Clinical Study Administrator

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 Pharmaceutical 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 (no match) 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.

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.

Key Job Activities:
Under direction of Clinical Operations personnel, and in accordance with all applicable Regional, state and local laws/regulations and corporate client 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 Johnson & Johnson 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:
  • Tracking
  • Written and verbal communications
  • Attention to details
  • Organizational skills