[Hiring] Clinical Research Associate @TFS HealthScience

Role Description

The Clinical Research Associate (CRA) is part of Strategic Resourcing Solutions (SRS) within TFS Health Science and will function operationally as a member of a Project Team and is responsible for the initiation, on-site and/or remote monitoring, close out of study sites during study conduct, according to company policies, SOPs and GCP and ICH guidelines and other regulatory requirements.

Key Responsibilities

• Monitor on-site and remotely clinical trials in accordance with TFS and/or sponsor Standard Operating Procedures GCP and ICH guidelines and applicable regulatory regulations.
• Perform all required monitoring activities at the study sites to assess and ensure subjects safety, data integrity and quality.
• Verify the protection of study participants by informed consent procedures and protocol requirements that follow appropriate regulations.
• Review CRFs (electronic or paper) and subject source documentation for validity and accuracy.
• Verify proper management and accountability of Investigational Product.
• Timely reporting of actions taken during monitoring visits in Monitoring Visit Report including findings, corrective and preventive actions already taken and update applicable tracking systems, as required; escalate observed deficiencies and issues as appropriate.
• Providing site with the listing of issues identified during monitoring visit and action items which will need to be addressed in a timely manner.
• Timely delivering site documents to eTMF or paper TMF; verify that the Investigator's Site File (ISF) is maintained in accordance with GCP and ICH guidelines and local regulatory requirements.
• Participate in audit and/or inspection, its preparation and follow-up activities, as needed.
• Order, ship, and reconcile clinical investigative supplies for study sites, if applicable.
• Update CTMS and all other required by projects systems with accurate site level information.

Qualifications

• Bachelor’s Degree, preferably in life science or nursing; or equivalent.
• At least 3 years of experience monitoring clinical trials in Oncology, including at least one involved in early-phase studies (Phase I or II).
• Able to work in a fast-paced environment with changing priorities.
• Understand basic medical terminology and science associated with the assigned drugs and therapeutic areas.
• Possess the understanding of Good Clinical Practice regulations, ICH guidelines.
• Ability to work independently as well as in a team matrix organization.
• Strong written and verbal communication skills.
• Fluent in English.
• Excellent organizational skills.
• Technology savvy and good software and computer skills.
• Soft skills: Self-awareness, resolute, flexibility, proactivity, collaborative mindset, analytic approach, and attention to detail.
• Ability and willingness to travel up to 60-80%, overnight and abroad if applicable.

Requirements

• Salary: 42.000-58.000 gross/year (depending on the level of experience), in line with CCNL Terziario-Servizi (Level III), plus benefits (lunch vouchers, health insurance, pension, and car allowance where applicable).

Benefits

• Competitive compensation package.
• Comprehensive benefits.
• Opportunity for personal and professional growth in a rewarding environment.