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22 days old

Clinical Study Associate

Kelly Services
Santa Ana, CA 92702
**Clinical Study Associate**




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.





**RESPONSIBILITIES**




+ Complying with applicable Corporate and Divisional policies and procedures, guidelines, standards and regulations.

+ Serving as internal support for all members of assigned teams.

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

+ Supporting establishment and maintenance of Trial Master Files for assigned clinical trials.

+ 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 assigned investigative sites, as requested by Study Managers, Lead CRAs, CRAs and other clinical trial team members.

+ 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.

+ Insuring all equipment/supplies provided to investigative sites is appropriately tracked and reported to Study Manager and/or Lead CRA.

+ Position directly supports Supervisor, Clinical Operations.

+ 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**




+ BA/BS or equivalent years of experience required.

+ 0-2 years of clinical research experience.

+ Ability to problem-solve.

+ Ability to multi-task and prioritize across tasks.

+ Good communication via written, verbal and listening skills.

+ Proficiency with MS Outlook, Word, Excel and Powerpoint.

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






**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: 2019-11-22 Expires: 2019-12-23

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Clinical Study Associate

Kelly Services
Santa Ana, CA 92702

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