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About the Role

This role supports the Regulatory Affairs Study Start-Up (RASSU) department by managing local submission documents, liaising with Ethics Committees and Competent Authorities, and ensuring accurate documentation in study systems. Additionally, it supports the CTI Legal team with contract-related communication and facilitates site budget activities, including training sites on budget templates and tracking progress.

Responsibilities

Inform the RASSU department about changes in Drug Law/guidelines and updated country-level submission requirements.
Review and prepare local submission documents for initial submissions, substantial amendments, and notifications to Ethics Committees and Competent Authorities.
Identify necessary Ethics Committees and Competent Authorities for studies on a country level.
Process pre-payments to Ethics Committees and Competent Authorities.
Adapt study-related documents to meet local country specifications in cooperation with the RASSU Specialist.
Serve as an applicant for Clinical Trials/RWE and act as a main point-of-contact for Ethics Committees, Competent Authorities, and RASSU Specialists.
Communicate closely with RASSU specialists regarding Ethics Committee/Competent Authority outcomes.
Apply naming conventions and process study documentation in the study start-up module or trackers and study-specific TMF system.
Perform Quality Control and Quality Assurance of various study-related Regulatory documents and reports.
Conduct review, reconciliation, close-out, and archiving activities of studies or projects.
Oversee translation of regulatory documents on behalf of the Sponsor, as agreed.
Attend internal and external study meetings and provide regulatory status reports for each site and country.
Foster relationships with key contacts at each site for the CTI Legal team.
Facilitate contract-related communication between the site and CTI.
Assist with site contract translation and track progress by updating internal systems, databases, and tracking tools.
Identify unique investigator, country, or site-specific issues and necessary ancillary agreements.
Assist with site contract execution.
Identify and establish relationships with site personnel responsible for budget proposals.
Interact with project management team members and clinical trials budget managers.
Maintain knowledge of site-specific budget templates and experience in completing them.
Train sites to understand budget templates and contents.
Communicate changes made by the site to clinical trials budget managers and vice versa.
Assist with translation, track progress by updating the Trial Interactive database, share drafts and final versions, and deliver the final negotiated budget to site personnel.

Requirements

1-2 years of experience in Clinical Research (pharmaceutical, site, or CRO service).
Experience in regulatory in country.
Associate’s or Bachelor’s Degree in an allied health field such as nursing, pharmacy, or health science, or equivalent relevant experience.
Fluent in spoken and written Italian and English.

Skills

Regulatory Affairs
Study Start-Up
Document Review
Submission Preparation
Ethics Committee Submissions
Competent Authority Submissions
Clinical Trials
Real-World Evidence (RWE)
Contract Management
Budget Management
Communication
Quality Control
Quality Assurance
Document Archiving
Translation Oversight
Database Management
Italian Language Proficiency
English Language Proficiency

Work Type

Hybrid

Experience Level

1-2 years

Education Level

Associate's Degree
Bachelor's Degree
Equivalent Relevant Experience

Benefits

Professional growth investment
Structured mentoring program
Leadership development courses
Dedicated training department
Support for ongoing education
Award-winning culture
Work-life balance support
Hybrid work opportunities
Opportunities to give back to the community through CTI Cares program

About the Company

CTI invests in professional growth through mentoring, leadership courses, and training.
CTI is an award-winning global team spanning 60 countries, prioritizing people and supporting work-life balance with hybrid opportunities.
CTI Cares program offers opportunities to give back to the community.
CTI's work directly contributes to advancing medicine and developing life-changing treatments for patients.