Clinical Research Associate

Overview: TFS HealthScience is expanding our Strategic Resourcing Solutions (SRS) team and is seeking an experienced, highly motivated Clinical Research Associate who shares our vision of providing clinical research excellence.
Our SRS team is a highly experienced international group of professionals led by industry experts.
We are a leading global mid-size Contract Research Organization (CRO) partnering with biotechnology and pharmaceutical companies throughout their entire clinical development journey.
We combine the full-service capabilities and global reach of a large CRO with the flexibility and personal approach of a mid-size CRO.
Our core values—Trust, Quality, Flexibility, and Passion—are what make TFS HealthScience successful today.
These values shape our culture and work ethic, guiding our organization.

What can we offer you? A great place to work with opportunities to advance your career in a global environment. The chance to be part of a team of highly intelligent, passionate experts worldwide. A focus on patients, saving lives, and improving quality of life by supporting our clients. Responsibilities: Monitor clinical trials on-site and remotely in accordance with SOPs, FDA regulations, GCP, and ICH guidelines. Identify site problems/deficiencies and report to management through trip reports, memos, and verbal communication with the Project Manager or Lead CRA. Initiate corrective actions as directed by supervisor. Participate in contract handling and negotiation under the guidance of Lead CRA or Project Manager. Set up and maintain Investigator Site Files (ISF) and Site Management Files (SMF), collaborating with the CTA as needed. Order, ship, and reconcile clinical supplies for study sites. Prepare and submit status reports as directed. Review and support site staff in maintaining SMF. Review Informed Consent documents for essential elements and protocol specifics. Update CTMS with site and study information. Qualifications: Bachelor's Degree in life sciences or nursing, or equivalent. 1-3 years of relevant clinical experience. Ability to work in a fast-paced environment with changing priorities. Understanding of medical terminology and science related to assigned drugs and therapeutic areas. Knowledge of GCP regulations and ICH guidelines. Ability to work independently and within a team. Excellent communication and organizational skills. Note: TFS HealthScience processes personal data in accordance with applicable laws.
For European applicants, see the privacy notice.
TFS does not discriminate based on race, sex, religion, age, or other protected categories.

Location: Roma, Italia

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