Clinical Study Associate

2 months ago

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

Join Kelly FSP as a Clinical Study Associate on site at our client location in Irvine, California


Job Function Summary

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 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 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.


Job Qualifications


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).


Additional Requirements

Demonstrated competencies in the following areas are required:

Tracking

Written and verbal communications

Attention to details

Organizational skills

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