Kelly Services has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a contract temporary opportunity to work as CRIM Associate at a prestigious Fortune 500® company working in West Chester, PA
Length: 1 year
Rate: $38 to $41/hour
The main objective of the CRIM Associate is to support Global Clinical Operations organization in planning, execution and finalization of the clinical portion TMF review.
In addition, the CRIM associate will be supporting setting up, managing and delivering complete and compliant clinical operation portion of the Trial Master File (TMFs). This involves managing oversight of the CROs activities related to the clinical operation portion of the TMF.
The CRIM Associate will be supporting GCO with preparing and participating in internal and external audits and inspections, in efforts related to TMF and supportive processes.
In addition, the CRIM Associate will be supporting use and maintenance of automated archives and records management systems, including those used by the Records and Information Management (RIM) department to index, store and access records/information.
Essential Duties & Responsibilities:
1. Support Global Clinical Operation teams in TMF review processes- including management of Internal & external TMF reviews- Inventory and QC of Clinical Documents ensuring GCO TMF files are structured according to Teva SOPs and completed as required.
As part of the TMF review process, The CRIM associate will be responsible to build, execute and finalize the finding resolution of the TMF review together with internal functions, CRO personnel and TMF review vendor, when applicable
2. Support Global Clinical Operation teams in TMF and eTMF set up processes, including defining TMF strategy, GSD TMF Plan, required TMF specification documents, Document management plans and sponsor study TMF review plan and CRO Oversight
3. Participate in GSD inspection readiness efforts, including supporting pre, during and post audit and inspection activities related to completeness and quality of the clinical portion of the TMF
4. Perform operational activities related to records receipt, data-entry and indexing, onsite and offsite storage, reference, retrieval and disposal activities to support the overall CRIM organization
5. Supports access requests and data dictionary maintenance of systems utilized by Global Clinical Operations (e.g., HPE-RM, CRO's eTMF, Teva eTMF etc.)
6. Identify and pursue continuous improvement opportunities to maximize effectiveness, minimize risks, enhance quality, and support change management initiatives globally.
7. Other tasks assigned by direct manager or as business needs require
Education Required: Bachelor or higher degree (Individuals with equivalent combination of education, training and related experience will be considered.)
Experience Required: At least 2 years' experience in clinical records management department at CRO, Sponsor or other relevant vendors
Practical experience working with Trial master file regulations and DIA reference model.
Knowledge of Windows programs (Word, Power Point, Outlook etc.)
Experience Preferred: Working with industry eTMF systems
Specialized or Technical Knowledge Licenses, Certifications needed: ICH-GCP
Functional Knowledge: knowledge in clinical studies and Pharmaceutical R&D
Knowledge in Regulatory requirements for clinical trials (ICH/GCP, FDA, EU Directive)
Knowledge of document management best practices.
Company/Industry Related Knowledge: Understanding of clinical data and pharmaceutical development
1. Ability to effectively interact with and influence others without direct reporting relationships
2. Ability to effectively work in a global environment
3. Works effectively in a multi-task environment
4. Interpersonal and communications skills
5. Very detail-oriented and meticulous in data review
6. Professional accuracy and integrity
7. Initiative, diligence, dedication, independent
8. Ability to work under pressure
This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must submit your resumes. Thank you for your interest in the assignment.
Also, feel free to follow up via email to RACS113@KELLYSERVICES.COM
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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.
Kelly Services, Inc. (NASDAQ: KELYA, KELYB) is a leader in providing workforce solutions.
Kelly offers a comprehensive array of outsourcing and consulting services as well as world-class staffing on a temporary, temporary-to-hire, and direct-hire basis.
Serving clients around the globe, Kelly provided employment to more than 540,000 employees in 2013. Revenue in 2013 was $5.4 billion.
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