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9 days old

Clinical Trials Study Assistant

Kelly Services
Jacksonville, FL 32232
Kelly Services is seeking a **Clinical Study Assistant** to provided administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations and SOPs in **Jacksonville, FL** .





This position offers enhanced benefits including paid vacation, paid holidays and paid sick time.





Length: Long term, open-ended, with room for growth





**CORE JOB RESPONSIBILITIES**




+ Close collaboration with other members within Clinical R&D

+ Supporting investigative sites toward completion and appropriate submission of all required clinical trial documents prior to site initiation

+ Coordinating Institutional Review Board/ Ethics Committee (IRB/EC) approvals, as appropriate

+ Supporting overall progress of clinical trials by regularly attending clinical trial team meetings, reviewing team communications and sharing pertinent information with clinical trial team members and investigative sites

+ Assisting assigned clinical trial teams to ensure that each clinical trial maintains audit/inspection readiness at each site and internally throughout the duration of assigned clinical trials

+ 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

+ Support user acceptance testing, review Electronic Data Capture (EDC) reports and data listings, and discuss findings with CRA

+ Coordinate and plan investigator meetings, site training, and other company functions

+ Monitor EDC for assigned Study

+ Co-monitor internal or external Clinical Study Site

+ Interacts with internal and external personnel involved in clinical research, including investigative site personnel, as appropriate

+ Supports the successful execution of assigned studies within budget and in conformance with global regulations and internal policies and procedures





**QUALIFICATIONS**




+ Bachelors degree or higher from an accredited institution and 1-2 years Clinical Study Assistant, or 3+ years' related experience

+ Strong organizational skills

+ Computer skills required: Microsoft Office products including 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

+ Fluent in English both verbally as well as with reading and writing skills

+ Good communication skills: written, verbal and listening

+ Ability to report to corporate offices for routine, daily work

+ Knowledge of FDA guidelines, regulations and/or Good Clinical Practice is a strong plus








**Why Kelly** **** **?**




The Managed Solutions practice within Kelly Outsourcing and Consulting Group (KellyOCG ) is one focus within the full array of Kelly Services workforce solutions.


Kelly Services has transformed from the staffing industry pioneer to a leading workforce solutions provider. KellyOCG is the distinguished outsourcing and consulting segment of Kelly Services, known for applying a forward-looking approach that enables companies to make strategic workforce planning decisions that impact their business and competitive advantage.


The Managed Solutions practice area of KellyOCG is dedicated to partnering with clients to architect and implement solutions that put them in a position to meet their operational obligation to their organization and freedom to focus on their more strategic business needs.


**AboutKelly Services** ****




As a workforce advocate for over 70 years, we are proud to have a role in managing employment opportunities for more than one million workers around the globe. We employ 550,000 of these individuals directly with the remaining workers engaged through our talent supply chain network of supplier partners. Revenue in 2015 was $5.5 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .


Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm
Posted: 2019-05-13 Expires: 2019-06-13

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Clinical Trials Study Assistant

Kelly Services
Jacksonville, FL 32232

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