About the job:
Responsible for assisting with the analysis and management of essential trial documentation for multiple regulated projects; Successfully and efficiently analyze and quality control (QC) individual trial/project specific essential regulatory documents
What You'll Do:
- Organize, manage, and maintain electronic trial documentation according to CTI SOPs or Sponsor SOPs/PSOPs and ICH/GCP guidelines
- Develop expert level of proficiency in the eTMF Reference Model Table of Contents (TOC) and document types listed in the TOC
- Provide high-level, timely support for document questions from internal and external sources including sponsors, CPMs and the eTMF Analysts
- Provide training and mentoring for new and existing team members
- Assist eTMF Manager in ongoing development of training materials, process improvement, and meeting agenda topics
- Providing support to the Clinical Team by responding to Part 1 Annual Review findings in trial documentation for completeness and accuracy of filed documents in both Trial Interactive, Veeva Vault, and other eTMF’s to be determined
- Manage Trial room assignment process for global regions, track progress and ensure list is current with assigned analysts
- Analyze and process trial documents electronically by performing a quality review for deficiencies, resolve discrepancies by using standard procedures or returning incomplete documents for resolution
- Sync documents and apply metadata according to the TOC and eTMF plan
- Provide data analysis, complete a quality review process, and file documents while managing multiple eTMF systems
- Perform content review as it pertains to each individual document type to ensure correct filing against trial specific TOC in the eTMF
- Verify accuracy of document electronic filing location by reviewing, correcting, deleting, or re-entering data
- Provide dedicated support for individual assigned eTMF’s, but also assist as needed for all trial eTMF filing
- Retain and apply trial specific knowledge to several eTMF’s as directed by the sponsor preference and use
- Maintain accurate eTMF’s by interacting with trial team members to resolve issues and inconsistencies.
- Retain and update job specific training tools and guides (via OneNote, SharePoint, etc.) to ensure quality document processing
- Utilize electronic tools (i.e., CTI Business Intelligence, SSRS, etc.) to stay ahead and track filing timelines for individual trials and escalate observed issues in timelines or specific documents.
What You'll Bring:
- Associate degree in allied health field such as nursing, pharmacy, or health science or the equivalent relevant experience
- 5 years of experience in pharmaceutical, site, or CRO service
Competencies:
- Ongoing willingness to learn
- Detail oriented
- Ability to lead and collaborate well in a team environment
- Ability to maintain confidentiality
- Strong computer skills
- Ability to provide a superior level of customer service
- Ability to prioritize, organize, and manage multiple tasks
- Basic awareness of and willingness to learn GCP, FDA regulations, and ICH guidelines
- Excellent verbal and written communication skills
About CTI
CTI Clinical Trial and Consulting Services is a global, privately held, full-service clinical contract research organization (CRO) focused on the advancement of treatments for chronically and critically ill patient populations. We assist clinical research throughout the lifecycle of development, from drug concept to commercialization. CTI is headquartered in the Greater Cincinnati, OH region with global operations in collaboration with pharmaceutical, biotechnology, and medical device firms. For more information, visit www.ctifacts.com
Why CTI?
Advance Your Career – We support career progression through a structured mentoring program and leadership courses that provide the support needed to grow. We also value ongoing education and training through tuition reimbursement and a dedicated training department.
Join an Award-Winning and Valued Team – We have an award-winning unparalleled culture that can be felt by our employees across 60 countries. We support a work-life balance and the importance of time with family by offering generous health benefits and vacation packages, hybrid work from home opportunities, and paid parental leave. We also encourage care for the world around us through our unique CTI Cares program.
Make a Lasting Impact – We focus on moving medicine forward by working on treatments for chronically and critically-ill patients, who depend on us to bring life-changing therapies to market.
Important Note
In light of recent increase in hiring scams, if you're selected to move onto the next phase of our hiring process, a member of our team will reach out to you directly from an @ctifacts.com email address to guide you through our interview process. Please ensure you are applying for jobs directly on our website (www.ctifacts.com) or from our verified LinkedIn page.
Please Note
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any point during the recruitment process
