Senior Clinical Research Associate Location: Milan area, Italy (home-based)
On behalf of our partner, one of the global leaders in clinical research, we are currently recruiting for an experienced Senior Clinical Research Associate in Italy to work for a global biotechnology company.
This particular CRA role is a client dedicated one where you will work exclusively on one sponsor's trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.
The CRA is responsible for the preparation, initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Detailed Job Duties and ResponsibilitiesAssesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and closes clinical trials at investigative sites.Reviews and verifies accuracy of clinical trial data collected, either on site or remotely.Provides regular site status information to team members, trial management, and updates trial management tools.Completes monitoring activity documents as required by SOPs or other contractual obligations.Escalates site and trial related issues per SOPs until identified issues are resolved or closed.Performs essential document site file reconciliation.Performs source document verification and query resolution.Assesses investigational product (IP) accountability, dispensation, and compliance at the investigative sites.Verifies SAE reporting according to trial specifications and ICH GCP guidelines.Communicates with investigative sites.Facilitates audits and audit resolution.To undertake other reasonably related duties as may be assigned from time to time as appropriate for experience and as required e.g. protocol amendment submissions, Investigator site budget negotiation.If responsible for supervising other CRAs, schedules and reviews trial tasks, provides leadership in the delivery of services to clients, ensures that staff fulfill their responsibilities in accordance with vendor's policies, procedures, and SOPs, and ensures HR processes are properly implemented.May support new CRA training.Functions independently with minimal oversight required.May serve as subject matter expert for clinical operations on monitoring-related activities.May be assigned to complex studies and/or sites.Provides leadership skills to assigned projects and within the Clinical Operations department.Education / Qualifications / Skills RequirementsUndergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (i.e., registered nurse); or equivalent work experience required.4 or more years of clinical monitoring experience mandatory.Previous experience in monitoring oncology studies would be an advantage.Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visit [COV]) preferred.Knowledge of ICH and local regulatory authority regulations regarding drug preferred.Experience in coaching/mentoring other CRAs preferred.Benefits:Various annual leave entitlements.A range of health insurance offerings to suit you and your family's needs.Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.Global Employee Assistance Program.Life assurance.Country-specific flexible benefits, including options like gym membership discounts, childcare vouchers, and more.KCR is a clinical development solutions provider creating value for emerging biotechnology organizations.
Founded in 1997, our expert teams support clients with full-service clinical development capabilities. As part of the ICON organization, KCR serves clients globally with key operations hubs in Boston, US, Berlin, Germany, and Warsaw, Poland. KCR's bespoke approach to service delivery for emerging Biotech companies combined with the global reach and scale of the ICON organization brings a uniquely comprehensive solution to the CRO market.
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