Clinical Research Associate Milano

Clinical Research Associate
Milano
Lombardia, Milano

Location: Milan, Italy

Job reference: R-215407

Date posted: 12/16/2024

The **Clinical Research Associate (CRA)** is responsible for the delivery of studies at assigned sites and actively participates in the local study team(s). Collaborating closely with local team members, the CRA ensures that study commitments are achieved efficiently and on time. Acting as the main contact with the study site, the CRA monitors study conduct to ensure delivery and compliance. Responsibilities include identification, selection, initiation, monitoring, and closure of assigned sites in clinical studies, adhering to Alexion Procedural Documents, international guidelines such as ICH-GCP, and relevant local regulations. Experienced CRAs may take on additional study-level responsibilities as needed.

**Accountabilities

- Performing identification, selection, initiation, monitoring, site data review, and closeout activities/visits (remote and onsite), as well as remote data checks, in accordance with the timelines specified in the study-specific Clinical Monitoring Plan (CMP).

- Driving performance at the sites by proactively identifying and ensuring timely resolution of study-related issues.

- Training, supporting, and advising Investigators and site staff in study-related matters, including Risk Based Quality Management (RBQM) principles.

- Developing recruitment plans with each site and managing enrollment to ensure sites meet enrollment milestones. Documenting recruitment barriers and implementing mitigation plans.

- Ensuring agreed monitoring KPIs are observed and remain within the agreed quality acceptable ranges.

- Preparing and finalizing monitoring visit reports in CTMS and providing timely feedback to the Principal Investigator.

- Ensuring timely collection/uploading of essential documents into the eTMF in accordance with ICH-GCP, Alexion SOPs, and local requirements. Supporting/participating in regular QC checks of the eTMF.

- In some countries, CRAs are accountable for study start-up and regulatory maintenance tasks.

- Contributing to the nomination and selection of potential investigators and assisting with feasibility activities.

- Collaborating with local Medical Affairs, Medical Advisor Pipeline (MAP), and other internal stakeholders as needed.

- Following quality issue processes by escalating systematic or serious quality issues to Global Study team, Local study team, Country Operations Line Management, and/or Quality Group representatives as required.

- Preparing for and collaborating with activities associated with audits and regulatory inspections.

**Essential Skills/Experience

- Minimum of 1 year of CRA monitoring experience

- Bachelor's degree in related discipline, preferably in life science, or equivalent qualification

- Excellent knowledge of international guidelines ICH-GCP, basic knowledge of GMP/GDP

- Excellent knowledge of relevant local regulations

- Good medical knowledge and ability to learn relevant Alexion Therapeutic Areas

- Good understanding of the drug development process

- Excellent understanding of Clinical Study Management including monitoring, study drug handling, and data management

- Excellent attention to details

- Excellent written and verbal communication skills

- Excellent knowledge of spoken and written English and Italian

- Excellent collaboration and interpersonal skills

- Good negotiation skills

- Demonstrates flexibility in schedule and willingness to travel (required travel may be as high as 70% during busy periods)

- Solid knowledge of clinical development processes with strong emphasis on monitoring

- Ability to use a computer; engage in communications via phone, video, and electronic messaging; engage in problem-solving and non-linear thought, analysis, and dialogue; collaborate with others; maintain general availability during standard business hours

**Desirable Skills/Experience

- Ability to work in an environment of remote collaborators and in a matrix reporting structure

- Manages change with a positive approach for self, team, and the business

- Ability to look for and champion more efficient methods/processes of delivering quality clinical trials with reduced budget and in less time

- Demonstrates ability to prioritize and manage multiple tasks with conflicting deadlines

- Proactivity and assertiveness when communicating with internal stakeholders and sites

- Ability to understand the impact of technology on projects and develop computer skills while making appropriate use of systems/software in an e-enabled environment

- Team-oriented and flexible; ability to respond quickly to shifting demands and opportunities

- Experience in all study phases and in rare medical conditions preferred

At AstraZeneca's Alexion division, we push the boundaries of science to transform complex biology into life-changing medicines for people living with rare diseases. Our unique position allows us to shape the future of rare disease treatment while maintaining transparency, ob