Hungary Job Openings

Icon plc
Senior Clinical Research Associate
Budapest
FULL TIME
October 18, 2024
- Assesses the qualification of potential investigative sites, initiates clinical trials at investigative sites, instructs site personnel on the proper conduct of clinical trials, and close 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.
- 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.
- 3 or more years of clinical monitoring experience mandatory
- Previous experience in monitoring oncology and any other 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.
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Various annual leave entitlements
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A range of health insurance offerings to suit you and your family’s needs.
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Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
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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.
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Life assurance
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Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.
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