Job Description

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

What You'll Do

• Initiate site contact and follow-up as necessary to turn study confidentiality agreements (CDA) and study clinical trial agreement (CTA) drafts
• Administer contract language to ensure it remains within approved sponsor guidelines and work with legal counsel on contract revision and negotiation
• Facilitate CDA and CTA completion and execution
• Attend internal and external project team meetings and report on CDA and CTA progress
• Maintain contract files and internal/external CDA and CTA tracking sheets
• Update CTA status within the internal study start-up module for all assigned studies
• Assist with contract preparation, review, revision, execution and filing
• Advise appropriate parties of significant terms (e.g. expiration dates, renewal terms, compliance obligations, etc.)
• Assist with CDA preparation, review, negotiation, execution and filing.
• Maintain CDA tracking
• Maintain CDA archives
• Process new consultant paperwork and maintain files

What You'll Bring

• Paralegal certification or Associate’s degree
• At least two years of experience in a professional administrative/business role
• Experience working in or with a pharmaceutical company or a Clinical Research Organization (CRO)
• Knowledge of FDA regulatory requirements and guidelines (i.e., Code of Federal Regulations [CFRs], International Conference of Harmonization [ICH] and GCPs)

Competencies

• Detail-oriented and organized
• Customer service oriented
• Maintain the highest level of confidentiality in ALL situations
• Ability to effectively communicate information to employees both verbally and in writing
• Ability to multi-task, track and stay organized in a fast paced, changing environment
• Ability to effectively use information technology, including a laptop computer and Microsoft software systems

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 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 hybrid work from home opportunities. 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