Clinical Study Administrator

This role is full-time and part of Kelly FSP (Functional Service Provider), a managed solution provider and business unit of Kelly Services, Inc.

About the role

This individual will provide support to the clinical study staff within Clinical Operations, performing 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.

Responsibilities

• Under direction of Clinical Operations personnel, and in accordance with all applicable regional, state, and local laws/regulations and corporate procedures and guidelines, provide support to project teams, which may include:
  • Tracking study data
  • Following up with clinical sites on essential documents
  • Assisting in drafting and distributing study mailings, including study newsletters
  • Assisting in drafting agendas, meeting minutes, and scheduling meetings
• Assist in payments and tracking for patient reimbursements
• Perform data entry in systems and run reports, including training matrix reports and metrics for management reviews
• Support management of IRB/IEC renewal compliance
• Coordinate the process for the review of study data, such as MRIs, by third-party vendors
• Assist in ordering, shipping, and tracking of study supplies, including 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
• Ensure 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 the Operating Company as needed
• 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

Requirements

• Minimum of a Bachelor’s Degree is required
• Previous clinical research experience
• Previous administrative support experience or equivalent for at least 1 year
• Clinical/medical background
• Experience and knowledge working with computer systems (Microsoft Office – Excel, Word, and PowerPoint)

Skills

• Tracking
• Written and verbal communications
• Attention to detail
• Organizational skills

Benefits

• Medical, Dental, and Vision coverage options
• 401K retirement plan
• A variety of other benefits to choose from
• Paid time off, including holiday, vacation, and sick/personal time