Kelly Services Clinical Data and Documentation Coordinator in Cambridge, Massachusetts
Every day, Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting 6+ month, long term contract opportunity as a Clinical Data and Documentation Coordinator for a top fortune 500 company in Cambridge MA.
Title: Clinical Data and Documentation Coordinator
Duration: 6+ months
Location: Cambridge MA
Essential Duties and Responsibilities:
Clinical Data and Documentation Coordinator within the Clinical Development Services division
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 client’s 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.)
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.
Strong attention to details
Strong interpersonal and communications skills
Strong organizational skills and techniques
Proven initiative and work ethic
Comfort working with data and data entry
Tolerance of ambiguity and willingness to work through complex issues
Ability to work with various client stakeholders to achieve desired goals
Proficiency with MS Office Applications, SharePoint, Visio, etc.
Education / 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
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States. Please contact Michelle Niemira ( email@example.com ) for immediate consideration.
As a Kelly Services employee, you will have access to numerous perks, including:
Exposure to a variety of career opportunities as a result of our expansive network of client companies
A competitive hourly pay rate with weekly checks
Access to newly expanded Medical Plan options
Online continuing education via the Kelly Learning Center
Several employee discounts
Why Kelly ® ?
As a worker today, it’s up to you to take charge of your career and look for opportunities to learn, grow, and achieve your potential. Helping you find what’s next is what we’re all about. We know what’s going on in the evolving world of work—just 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 , we’re always thinking about what’s next and advising job seekers on new ways of working to reach their full potential. In fact, we’re 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.
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