Clinical Research Coordinator/Research Nurse (Freelancer, Onsite, Genoa Italy)

POSITION SUMMARY:

An experienced Clinical Research Coordinator/Research Nurse will work in collaboration with the principal investigator and other members of the research team at a leading teaching hospital in Genoa, Italy to assist with conducting four (4) industry-sponsored protocols for rare growth disorders

Type: Onsite

Position Reports to: PI or Designee

Shift: 8-hour days. Monday- Friday

Duration: 24 months

Location: Teaching Hospital in Genoa, Italy

Anticipated Start Date: ASAP

ESSENTIAL JOB FUNCTIONS:

• Recruit and screen study participants in accordance with the approved clinical research protocol and inclusion/exclusion criteria
• Obtain and document informed consent in compliance with ICH-GCP, AIFA, and site-specific ethical requirements
• Conduct participant interviews to collect accurate medical and health histories
• Coordinate and support study visits, maintaining regular contact with participants in person and by telephone as appropriate
• Recognize and promptly report any physical or psychological changes or adverse events to the Principal Investigator (PI)
• Assist investigators during study-related examinations and procedures as outlined in the protocol
• Administer investigational products (IMP) or study-related medications as authorized, ensuring accurate documentation of each administration and maintaining compliance with local regulations and study pharmacy procedures
• Maintain strict accountability for study drug/IMP, including receipt, storage, temperature monitoring, dispensing, return, and reconciliation in coordination with the site pharmacist
• Order, track, and manage laboratory tests and diagnostic exams according to the protocol and in coordination with the site laboratory, pharmacy, and other ancillary departments (e.g., radiology, nutrition, psychiatry)
• Ensure accurate, complete, and timely entry of study data in source documents and electronic data capture (EDC) systems, ensuring traceability and audit-readiness
• Verify data accuracy against source documents and collaborate with monitors (CRAs) to resolve queries and implement data corrections when required
• Support the PI in identifying, assessing, and reporting adverse events (AEs) and serious adverse events (SAEs) per regulatory and sponsor requirements
• Provide participants and caregivers with clear verbal and written instructions regarding study procedures, visit schedules, and follow-up requirements
• Maintain strict adherence to the IRB/EC-approved protocol, institutional SOPs, and GCP standards
• Participate in site meetings, monitoring visits, and audits as required

KNOWLEDGE, SKILLS & ABILITIES:

• Minimum of 3 years of experience as a Study Coordinator or Research Nurse in clinical research or a related medical setting
• Training or certification in Human Subjects Protection / Good Clinical Practice (GCP) completed within the past year (CITI or equivalent EU-recognized training)
• Solid knowledge of ICH-GCP guidelines, European (EMA) and Italian (AIFA) clinical research regulations, institutional Standard Operating Procedures (SOPs), and Quality Assurance / Quality Control principles
• Excellent interpersonal, organizational, and computer skills, with strong verbal and written communication abilities
• Legal authorization to work in Italy
• Proficient in English (written and spoken)
• Fluent or native in Italian
• Currently residing within commuting distance to Genoa

PREFERRED QUALIFICATIONS:

• Master’s degree in Clinical Study Coordination, Research Nursing, or a Master’s in Coordinamento e Gestione degli Studi Clinici preferred
• Prior experience as a libero professionista preferred
• Previous experience working with pediatric populations preferred
• Previous experience in rare disease clinical studies preferred

COMPANY DESCRIPTION

RapidTrials is a specialized global staffing partner dedicated to advancing clinical research through people. We connect experienced Study Coordinators, Research Nurses, Dietitians, and Patient Navigators with leading biopharmaceutical sponsors, CROs, and research sites worldwide.

By managing the contracting, onboarding, and compliance process, RapidTrials enables site teams and investigators to stay focused on what matters most—high-quality research and patient care. Each placement is thoughtfully matched to ensure alignment with professional experience, site needs, and local regulatory requirements.

With operations across Europe and North America, RapidTrials provides access to meaningful, flexible assignments supporting cutting-edge clinical trials in oncology, metabolic and liver disease, obesity, rare diseases, and gene therapies.