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Clinical Study Assistant

Kelly Services


Location:
Santa Ana, CA
Date:
04/23/2018
2018-04-232018-05-22
Job Code:
US33MXGR_BH1428981
Kelly Services
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Job Details

Job Title Clinical Study Assistant

Jobid US33MXGR_BH1428981

Location: Santa Ana, CA, 92702, USA

Description **Clinical Study Assistant**

Kelly’s Outsourcing & Consulting Group is seeking candidates for a **Clinical Study Assistant** opportunity in **Santa Ana, California** . This is an **open-ended salaried position and comes with enhanced benefits** *. The Clinical Study Assistant provides administrative and organizational support for assigned clinical trials and sites in accordance with Good Clinical Practice (GCP), guidelines, standards, federal regulations and SOPs. Close collaboration with other members within Clinical R&D.

Core Job Responsibilities

• 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, as requested.

• 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

• Other duties as assigned

Position Accountability / Scope

• 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.

Minimum Experience/Training Required

• Bachelor’s 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:

o 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

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

• Good communication via written, verbal and listening skills.

• Ability to report to corporate offices for routine, daily work.

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

If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

*This position comes with enhanced benefits which include:

• 50/50 shared healthcare cost (Kelly pays 50% of the monthly premium, employee pays 50%)*

• Paid holidays

• Paid sick days and vacation days*

Perks of being a Kelly employee:

• Weekly electronic pay

• Access to more than 3,000 online training courses though Kelly Learning center

• Online application system

• Never an applicant fee

*benefits to be received upon meeting eligibility requirements

Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at gail.robilliard@kellyservices.com.


**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



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