Senior Clinical Research Associate (Italian Contractor)

at  Theradex Oncology

Who We Are:
Theradex Oncology is a full-service CRO, conducting early- and late-phase oncology trials in the U.S, Europe and Asia. Theradex Oncology was founded in 1982, when we were awarded the Clinical Trials Monitoring Contract for the National Cancer Institute (NCI). Our ongoing association with NCI continues to be a strong basis for our operations. Our focus is cancer. We fully understand the science behind each potential cancer therapy and the challenges that come with moving therapies from mice to man. Theradex Oncology has designed and managed more than 250 early and late-phase oncology trials to date. Our mission is to assure that new discoveries in cancer drug development have the very best opportunity to be of benefit to mankind with a vision to improve treatment and make cancer a livable disease.
What You’ll Do:

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 managingclinical trial sites
• Experience in monitoring oncology early phase studies

SKILLS AND COMPETENCIES TO BE DEMONSTRATED:

• Professional attitude with good customer focus.
• Effective communication skills: verbal/written/presentation.
• Good interpersonal skills, including persuasion and influence.
• Able to work independently as well as in a group.
• Good time management, multitasking and execution skills.
• Good organizational skills, including efficiency, punctuality, and collaboration in a team environment.
• Demonstrated proficiency in Microsoft Outlook, Word, Excel and PowerPoint.
• Technically proficient enough to work in a remote environment and able to address minor technical challenges without support but will timely escalate to Information Technology Support for challenges beyond capabilities.
• Capable of absorbing and applying knowledge gained through internal and external trainings on protocols assigned.
• Knowledge of ICH Guidelines and GCP including an understanding of regulatory requirements.
• Effective knowledge of the drug development process and the Theradex organizational structure
• Candidates must be fluent in Italian
• Candidate must be fluent in English.

• 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).
• Performs ongoing management of essential regulatory documentation at the outset and across the lifespan of a study
• Performs quarterly QC of assigned studies/sites in the eTMF according to Theradex Oncology SOP.
• Performs 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.
• Ensures 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 simultaneousl