Clinical Mon Assoc I in London

Responsibilities

• 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.

Qualifications

• 1 year of research industry experience or equivalent experience.
• Bachelor’s degree in allied health fields such as nursing, pharmacy, or health/natural science.
• 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.
• 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.

Benefits

• 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.