Clinical Study Administrator

Vita Global Sciences, a Kelly Company; Irvine (CA); On-site; USD 52,000 - 78,000; Full time

Benefits offered by this job

Medical, Dental, Vision benefits

401K and paid time off

Job summary

Kelly Science and Clinical FSP is seeking a Clinical Study Administrator for a long-term engagement with a Global MedTech client. This role supports the Clinical Operations team and performs routine and technical duties in clinical trial operations.

You will assist project managers, manage study data, prepare study mailings and minutes, and help ensure regulatory compliance across regional/state guidelines. Strong organization and communication skills are essential.

Qualifications

• Minimum of a Bachelor’s Degree is required.
• Previous clinical research experience.
• Requires previous administrative support experience or equivalent for at least 1 year.
• Clinical/medical background.
• Requires experience with computer systems (MS Office: Excel, Word, PowerPoint).

Responsibilities

• Provide support to the clinical study staff within Clinical Operations.
• Perform a variety of clinical research operations duties in support of clinical trials.
• Support project managers within the assigned clinical studies.
• Track study data and follow up with clinical sites on essential documents.
• Assist in payments/tracking for patient reimbursements.
• Enter data in systems and run reports for management reviews.
• Coordinate review of study data (e.g., MRIs) by third-party vendors.
• Schedule investigator and expert panel meetings and assist with audits.

Skills

Attention to detail

Organizational skills

Written and verbal communication

MS Excel

MS Word

Education

Bachelor's degree

Tools

Microsoft PowerPoint

Job description

Kelly Science and Clinical FSP is currently seeking a Clinical Study Administrator for a long-term engagement with one of our Global MedTech 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.

Job Description

Position Title: Clinical Study Administrator

Division: Clinical Operations

Reports To: Study Team Lead

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 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 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 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