Clinical Study Assistant Job Listing at Kelly Services in Jacksonville, FL (Job ID 9568937)

Description

Clinical Study Assistant

SUMMARY

This position supports clinical studies from study start-up through close-out.  The Clinical Study Assistant is responsible for supporting Clinical Operation Managers (COM) and Clinical Research Associates (CRA), to ensure clinical study documentation (trial master file) is complete, accurate and on file according to standard operating procedure, as well as assist with clinical trial progress tracking and reporting as required.

The CSA position will adhere to safety and environmental policies and procedures and support department objectives.

ESSENTIAL FUNCTIONS
 

• Enter and maintain required documentation in study specific databases related to purchases, contracts, health care compliance, study document management, and other areas as required
• Responsible for the set-up of  the Trial Master File, investigator study file binders and regulatory document collection
• Review protocols and study documents to ensure consistency and accuracy
• Coordinate and plan investigator meetings, site training, and other company functions
• File and review all appropriate test article accountability reconciliation form from study sites
• Other duties as assigned

RESPONSIBILITIES
The expectation is that this position can independently handle collecting legal documents and contracts through the appropriate channels to be approved and payments initiated.  Invoices must be collected, quality checked, and reconciled against milestones stated in the applicable contracts per Sarbanes Oxley.
Using the appropriate system applications, this position is accountable for the following activities:

• Obtain CR (Protocol) number
• Create Trial Master File
• Generate site regulatory binders
• Perform debarment checks
• Review, track, scan and upload regulatory documents to eTMF, and file in TMF
• Schedule and set up Site Initiation Training meetings
• Work with on-site printing vendor as required to generate study documents (e.g., ICFs, assents, questionnaires, instructions)
• Request and submit Research Agreements for approval
• Field all study-related questions and document in communication file in TMF
• Regular TMF review
• Schedule meetings, generate and publish meeting minutes
• Keep calendar
• Create transaction records in and upload documents to the appropriate systems
• Format and finalize draft protocols to Regulatory and SOP standards
• Initiate document review, approval and finalizing processes
• Track, reconcile, and report  budget and payments
• Supplier set up and database maintenance

 QUALIFICATIONS

• • Bachelor's degree or higher from an accredited institution and 1-2 years' Clinical Trial Coordinator I, or 3+ years' related clinical experience.
  • Strong organizational skills
  • Computer skills required:
    • Microsoft Office products – Word, Excel, PowerPoint, Project, and SharePoint
  • Ability to work with minimal supervision in a Team environment 
  • The ability to understand written work instructions and follow the requirements
  • Highly developed communication skills to include all levels of an organization
  • 1 year leadership experience preferred
  • Knowledge of FDA guidelines, regulations and/or Good Clinical Practice a strong plus

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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