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Sr. Clinical Research Associate
2 mesi fa
ICON plc is a world-leading healthcare intelligence and clinical research organization. We're proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.
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.
Responsibilities:
- Assesses 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.
Requirements:
- Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (ie, 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.
What ICON can offer you:
Our success depends on the quality of our people. That's why we've made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family.
- Various annual leave entitlements.
- A range of health insurance offerings to suit you and your family's needs.
- Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
- Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family's well-being.
- Life assurance.
- Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we've done to become a more inclusive organisation. We're dedicated to providing an inclusive and accessible environment for all candidates.
Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless - there's every chance you're exactly what we're looking for here at ICON whether it is for this or other roles.
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