Senior Clinical Research Associate (Italian Contractor)

Who We Are

Theradex Oncology has designed and performed more than 350 early-phase oncology trials to date. As a full service CRO, Theradex Oncology knows how to assist its clients in developing successful strategies and executing studies in cancer treatment. Our mission is to ensure that new opportunities in drug development have the very best chance to be of benefit to mankind, with a vision to make cancer a livable disease. With over 40 years of experience focused entirely on oncology, we are passionate specialists. We understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Our head office is based in Princeton, NJ, USA, while our European operations are managed from our London office.

What You'll Do

We are hiring a Freelance SCRA (Italian Speaker) based within a 2-hour commute from Milan on a 0.3 FTE per month (will vary from 0.2 to 0.9 monthly for a 6-month contract).

The primary responsibilities of this position include, but are not limited to, the following:

• Assist in the preparation of project specific materials e.g., status reports, newsletters, templates, study manuals/binders, etc.
• Maintain an awareness of the literature on cancer therapy, clinical trial design and conduct, and good clinical practice.
• Collaborate with other members of the project team to meet Sponsor, Protocol and Theradex objectives of Regulatory Readiness including contract and budget negotiations, as required.
• Establish and maintain effective, routine communications with study sites, providing timely study updates and support to sites.
• Establish and maintain effective, routine communications with the internal project team, providing timely project team updates on site-related issues.
• Responsible for assisting in the preparation of the Investigator and Sponsor files with essential documents for the initiation of sites participating in clinical studies.
• Maintain up-to-date site information (including all contact details and distribution lists for reports and clinical supplies).
• Perform ongoing management of essential regulatory documentation at the outset and across the lifespan of a study.
• Perform quarterly QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP.
• Perform study tracking via CTMS, investigator site file tracker (if utilized) and/or sponsor designated system to ensure that the study files are current, accurate and complete.
• Ensure protection of subjects, subjects’ rights, and the integrity of data through adherence to Good Clinical Practice, applicable regulatory requirements, Standard Operating Procedures, and protocol compliance.
• Participate in the conduct of pre-qualification, initiation, routine monitoring, remote monitoring, and close-out visits in accordance with the relevant SOPs.
• Proactively identify and resolve potential site and study issues.
• Identify and escalate data quality issues to ensure clinical data integrity.
• Provide support to project management via ongoing project reports and updates.
• May be responsible for supporting multiple studies simultaneously.

What You Need

Level of Education:

• At minimum, Bachelor's degree (BSc, BA, or RN equivalent) in biological or human science-related field or equivalent experience.

Prior Experience:

• At least 5 years’ experience as a Clinical Research Associate with a sound track record in managing clinical trial sites.
• Experience in monitoring oncology early phase studies.

Skills and Competencies to be demonstrated:

• Thorough knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Highly effective multitasking and execution skills.
• Excellent interpersonal skills, including communication, presentation, persuasion, and influence.
• Excellent organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Knowledgeable in the identification, anticipation, and reporting to appropriate management problems relating to study conduct, and highly effective in developing solutions to those problems.
• Effective knowledge of the drug development process and the Theradex organizational structure.
• Strong communication skills: verbal and written.
• High level of proficiency in Microsoft Outlook, Word and Excel.
• Candidates must be fluent in Italian.
• Candidates must be fluent in English.

What we offer:

Theradex is an equal opportunity employer. All qualified applicants are encouraged to apply and will receive consideration for employment.