Clinical Study Administrator

2 weeks ago

Irvine, United States Kelly Science, Engineering, Technology & Telecom Full time

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 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 general direction of Clinical Operations personnel, and in accordance with all applicable Regional, state and local laws/regulations and corporate Johnson & Johnson procedures and guidelines, this position will

  • As directed, provides general 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 administrative support to Clinical Operations staff, as needed.


Education

Minimum of a Bachelor’s Degree is required.


Experience

Previous clinical research experience a plus.

Requires previous administrative support experience or equivalent for at least 1 year.

Clinical/medical background a plus.


Knowledge

Requires experience and knowledge working with computer systems (Microsoft office – Excel, Word and Power Point).

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