Clinical Monitoring Associate for Our Italian Team

**JOB PURPOSE / SUMMARY**
- 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).**ESSENTIAL FUNCTIONS**
- Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.- 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

**SUPERVISORY RESPONSIBILITY (if any)**
- This position does not have supervisory responsibility

**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

**REQUIRED EDUCATION AND EXPERIENCE**
- 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