- Esperienza
- 2+ anni
- Stipendio
- —
- Aperture
- 1
- Pubblicato
- 1 settimana fa
- Modalità di lavoro
- In ufficio
- Istruzione
- Degree in a scientific field
- Requisiti di ammissibilità
- Candidates with a scientific degree and at least 2 years of CRA or clinical trial monitoring experience may apply.
- Riprendere
- È necessario candidarsi
Descrizione del lavoro
Role overview
The Clinical Research Associate will oversee the running and tracking of clinical studies to make sure they follow the approved protocol, ICH-GCP standards, and all relevant regulations. The position covers site identification, study start-up, monitoring, and close-out, with a strong focus on data integrity and participant safety. This role reports to the Clinical Project Manager.
Core responsibilities
- Assess potential investigational sites, select suitable locations, and support site activation.
- Carry out feasibility reviews, pre-study assessments, site initiation, routine monitoring, and close-out visits.
- Verify that trial conduct aligns with protocols, SOPs, ICH-GCP, and applicable regulatory obligations.
- Check source records to confirm that study data is complete, accurate, and traceable.
- Track enrollment progress and help sites stay on course with recruitment goals.
- Review and escalate adverse events and protocol deviations as required.
- Oversee investigational product receipt, storage, use, and accountability.
- Keep essential trial documentation current, including TMF/eTMF and Investigator Files.
- Prepare monitoring visit reports and related follow-up correspondence.
- Work closely with sponsors, project teams, and site personnel to keep studies on track.
- Assist with audits and inspections, and provide guidance to junior CRAs when needed.
Candidate profile
- A degree in a scientific discipline is required.
- At least 2 years of experience in CRA work or clinical trial monitoring is expected.
- Working knowledge of ICH-GCP, ISO14155, and general clinical trial operations is essential.
- Strong command of English and confidence using Microsoft Office are needed.
- Excellent organization, communication, and problem-solving skills are important.
- The role suits someone who can work both independently and collaboratively.
About OPIS
OPIS began in Italy in 1998 and has grown into an international, science-led biotech CRO. The company delivers end-to-end trial management for multi-country studies, supported by advanced technology and modern approaches to complex projects. Its strength comes from a highly specialized team with deep expertise across clinical trial management, medical writing, scientific and statistical consultancy for study design, regulatory support, pharmacovigilance, and more.
Compensation and benefits
A competitive salary is offered, along with additional benefits and bonuses. The company also provides an opportunity to build and advance your professional career within a growing organization.
Additional information
Please review the data processing information notice available in the candidates information section of the company website.