About the job:
Responsible for project activities associated with monitoring functions of Phase I through Phase IV clinical research studies and Real World Evidence (RWE) studies while developing an understanding of the drug development process, International Conference on Harmonization (ICH) / Good Clinical Practice (GCP) and relevant regulations. Performs management of study site activities in adherence to all applicable regulatory guidelines and Standard Operating Procedures (SOPs).
What You'll Do:
- Perform in-house monitoring activity related to clinical trials while adhering to all applicable regulatory and SOPs
- Perform on-site clinical trial monitoring, co-monitoring, and close-out activities, with oversight from project CRAs when required, while adhering to all applicable regulatory requirements and SOPs
- May conduct independent on-site monitoring as sponsor requirements allow
- Assist project teams with study start-up activities, including site selection and phone Pre-Study Visits to identify and evaluate potential investigative sites
- Collect, review, file, and track regulatory documents for investigative sites, when required, including assisting the project CRA with reconciliation of the TMF/eTMF
- Participate in or conduct study specific training for CTI personnel or investigative sites
- Attend Investigator or sponsor meetings
- Assist in development of monitoring tools for study, including remote monitoring checklist for eCRF studies
- Conduct routine remote monitoring of eCRF studies, issuing queries in the database
- Compile monitoring visit packets and provide to project CRAs prior to on-site monitoring visits
- Assist in maintaining project-related tracking for CRA visit reports and letters, protocol deviations, serious adverse events (SAEs), and IND Safety reports
- Contact sites to ensure proper completion of monitoring / data management queries within timelines, resolution of action items related to Interim Monitoring Visits, and other site management tasks
- Serve as support / contact for CRA Team questions
- Assist with project-specific administrative activities as member of project team
- Increase knowledge of drug development process, therapeutic areas, ICH / GCP, and any applicable local regulatory requirements
What You'll Bring:
- 1 year of research industry experience or equivalent experience
- Bachelor’s degree in allied health fields such as nursing, pharmacy, or health / natural science or
- RN with Associate’s Degree
PREFERRED EDUCATION AND EXPERIENCE
- Previous experience conducting clinical pharmaceutical research studies at research site, pharmaceutical company, or CRO
- Experience or education providing sound basic knowledge of medical and pharmaceutical terminology
- Master’s Degree in allied health fields such as nursing, pharmacy, or health / natural science
-
Competencies:
- Excellent verbal and written communication skills
- Excellent organizational, record retention, and time management skills
- Excellent decision-making, customer service, and interpersonal skills
- Ability to process visit reports and expense reports effectively
- Ability to obtain credit cards for purpose of paying expenses while traveling
- Ability to work independently and as part of project team
- Proficient in use of laptop computer and software systems
- Ability to understand basic and complex medical details
- Understanding of basic data processing functions is preferred
- Knowledge of ICH / GCP and all applicable local regulatory requirements is preferred
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
