About us
1MED SA is a Clinical Research Organization (CRO) supporting Pharmaceutical, Biotechnology, Medical Device, and In Vitro Diagnostic companies across Europe.
Our teams contribute to a wide range of clinical research activities, including Phase I-IV clinical trials, clinical investigations, post-market clinical follow-up (PMCF) studies, observational studies, and post-market research programs.
As part of our continued growth, we are looking for a Clinical Research Associate (CRA) / CRA II to join our Clinical Operations team.
We are currently considering candidates based in both Italy and Switzerland, as we are recruiting for equivalent CRA positions across our organizations.
The successful candidate will have the opportunity to work across a diverse portfolio of Pharmaceutical and Medical Device studies, gaining exposure to different therapeutic areas, technologies, and regulatory frameworks.
For candidates supporting medicinal product clinical trials in Italy, compliance with the applicable CRA qualification requirements under the Italian Ministerial Decree of 15 November 2011 will be required. Candidates with relevant CRA experience who do not yet fully meet these requirements may be considered where an appropriate qualification and training pathway can be established by 1MED.
Position Summary
The Clinical Research Associate (CRA)/ CRA II is responsible for ensuring that clinical studies are conducted in compliance with applicable regulations, ICH-GCP guidelines, study protocols, sponsor requirements, and company procedures.
Acting as the primary point of contact for assigned investigational sites, the CRA supports studies throughout their lifecycle, from site qualification and initiation through monitoring and study close-out, while contributing to data quality, regulatory compliance, and patient safety.
Key Responsibilities
Site Monitoring & Site Management
- Conduct Site Qualification/Selection Visits (SQV/SEV).
- Perform Site Initiation Visits (SIV).
- Conduct Interim Monitoring Visits (MOV), both on-site and remotely.
- Perform Site Close-Out Visits (COV).
- Prepare monitoring reports, follow-up letters, and related study documentation.
- Ensure timely follow-up of site action items and identified issues.
- Evaluate site performance and proactively identify areas requiring additional support.
Clinical Trial Oversight
- Ensure studies are conducted in accordance with study protocols, ICH-GCP, ISO14155 and applicable regulations, sponsor requirements, and company SOPs.
- Verify informed consent processes and documentation.
- Perform Source Data Verification (SDV) and Source Document Review (SDR).
- Review medical records and study documentation.
- Verify the accuracy, completeness, and consistency of CRF/eCRF data.
- Identify, document, and follow up protocol deviations and corrective actions.
- Escalate quality, compliance, or patient safety concerns when appropriate.
Patient Safety & Data Integrity
- Verify that Adverse Events (AEs), Serious Adverse Events (SAEs), Serious Adverse Device Events (SADEs), Device Deficiencies, and Concomitant Medications are properly documented and reported.
- Contribute to maintaining patient safety and data integrity throughout the study.
- Support compliance with applicable pharmacovigilance and materiovigilance requirements.
Investigational Product & Device Accountability
- Verify appropriate storage, handling, accountability, reconciliation, and disposition of Investigational Medicinal Products (IMP), Medical Devices, and study supplies.
- Ensure compliance with sponsor and regulatory requirements regarding product accountability.
Site Support & Training
- Act as the primary contact for Investigators and site personnel.
- Provide study-specific and GCP-related training as required.
- Support subject recruitment, retention, and site engagement initiatives where applicable.
- Collaborate closely with Project Managers, Sponsors, and other cross-functional teams.
Documentation & Quality Management
- Maintain and review Investigator Site Files (ISF).
- Support reconciliation activities between site documentation and the Trial Master File (TMF/eTMF).
- Contribute to audit and inspection readiness.
- Ensure timely and accurate completion of all required study documentation.
Qualifications
- For candidates who will monitor medicinal product clinical trials in Italy, existing compliance with the CRA qualification requirements of the Italian Ministerial Decree of 15 November 2011 is highly desirable. Candidates with appropriate CRA experience who do not yet fully meet these requirements may also be considered, with qualification/training supported by 1MED where appropriate.
- Bachelor's Degree or higher in Life Sciences, Pharmacy, Biotechnology, Nursing, Medicine, Biomedical Sciences, or a related scientific discipline.
- Minimum 2 years' experience as a CRA, with demonstrated experience conducting independent site monitoring visits.
- Experience in Pharmaceutical Clinical Trials and/or Medical Device Clinical Investigations is highly desirable.
- Experience working within a CRO environment is considered an advantage.
Skills & Competencies
- Good understanding and/or practical experience of ICH-GCP and/or ISO 14155, with familiarity with EU MDR clinical investigation and PMCF requirements.
- Knowledge of applicable clinical trial regulations and quality standards.
- Ability to manage multiple studies and priorities simultaneously.
- Strong relationship-building skills with investigators and study site staff.
- Ability to work independently and within cross-functional teams.
- Commitment to quality, compliance, and patient safety.
- Availability to travel nationally and internationally (approximately 30-60% depending on study and project requirements).
- Italian, and good professional English are required. Additional European languages, particularly German and/or French, would be considered a strong advantage.
Systems & Technology
- Experience working with EDC/eCRF platforms.
- Familiarity with eTMF systems.
- Good knowledge of Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
- Experience with Clinical Trial Management Systems (CTMS) is considered an advantage.
Comfortable working with remote monitoring and digital collaboration tools.