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
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