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10 days old

Clinical Data & Document Coordinator

Kelly Services
Cambridge, MA 02238
**Kelly Services** is currently seeking a **Clinical Data and Document Coordinator** in **Cambridge, MA** to work a contract assignment 6 **month duration** for one of our top clients. Kelly is a full service workforce solutions provider to 98% of the Fortune 100 companies. We provide employment to more than 700,000 people annually and we deal with some of the largest and best companies both nationally and locally.



**Primary Responsibilities includes:**



Works closely with Manager and Clinical Operations personnel to perform quality checks and file Clinical Trial Master File TMF to ensure high quality documentation in accordance with country-specific regulations, ICH Guidelines, Good Clinical Practices GCPs , and Standard Operating Procedures SOPs and Business Practices. Provides centralized support for document upload and data entry in operational and document management systems e.g., CTMS, clinical trial and budget tracking, electronic Trial Master File eTMF , electronic document management system EDMS etc.



Duties and Responsibilities: Conducts quality checks of the Clinical TMF documents. Work with internal functional area document owners and CRO to remediate any issues identified with Clinical TMF documents during quality check. Scans, files and maintains study documentation in the Clinical Trial Master Files and in the electronic Trial Master Files system and/or applicable Records Management system. Provides central support for uploading clinical TMF documents to EDMS to support key trial activities e.g., regulatory submissions, clinical study reports etc. . Work with GDO stakeholders to review and manage operational clinical trial data to ensure quality and completeness per data quality standards and specified system guidelines. Provide centralized data entry support for operational systems ensuring alignment with data quality standards. Review and contribute to processes and tools in support of maintaining operational and document management systems to ensure quality and completeness. Review operational data to inform and document trends and risk areas to key stakeholders. Support other trial related operational activities as needed and assigned.



Qualifications:Experience:BA/BS with 1-3 years of industry or comparable experience; candidates with some clinical research educational courses and knowledge of regulatory and Good Clinical Practice requirements preferred; understanding of the Trial Master File including understanding of the DIA TMF Reference Model preferred; experience working in electronic Trial Master File specifically Veeva Vault eTMF platform preferred; internal candidates must have demonstrated high performance in current position



Proficiency with MS Office Applications, SharePoint, Visio, etc



**APPLY NOW!**




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



As a worker today, its up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find whats next is what were all about. We know whats going on in the evolving world of workjust ask the nearly 500,000 people we employ each year. Connecting with us means getting the support, guidance, and opportunities needed to take your career where you may have never imagined.




**About Kelly** ****



At **Kelly** , were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live. Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.


Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. Equal Employment Opportunity is The Law.

\#KellyGTS

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Posted: 2020-05-22 Expires: 2020-06-22

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Clinical Data & Document Coordinator

Kelly Services
Cambridge, MA 02238

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