Job Description

Job Description

ICON Dedicated to a single sponsor

Vaccine - Clinical Research Associate

• 7-9 protocols, up to 10
• CRAs become experts and the studies are easy to manage because they are very similar regardless of the indication. Once you get used to the pace and volume it’s actually fairly straight-forward.
• 15 Sites
• If any sites are high enrolling that the monitor’s site load will be reduced.
• Sponsor utilizes risk-based monitoring and co-monitoring.
• 8 to 10 days on-site per month – some visits are two days
• Opportunity to be able to start and complete trials in a year which is not common in other Therapeutic areas.
• Vaccine trials are fast-paced with quick database cleaning demands.
• Because of the fast nature of these vaccine trials, CRAs have the opportunity to experience all parts of the trial from SSU to close-out. Studies move fast and the CRAs are constantly starting new studies and closing out studies.
• Healthy subject populations do not have very many SAEs
• Very few regulatory documents related to study changes compared to other therapeutic areas

What you will be doing:

• Completes onsite and remote monitoring activities in accordance with all ICH-GCP guidelines, applicable regulations, SOPs, and study processes. Activities include qualifying potential investigative sites, initiating clinical trials, maintaining study files, and providing instructions to site personnel and study close out.
• Verifies the protection of study participants by confirming informed consent procedures and protocol have been performed in accordance to applicable regulations.
• Ensures the integrity of clinical data and that the study is conducted in compliance with the approved protocol, GCP, applicable regulations, and SOPs.
• Manages the investigative site staff to facilitate trial deliverables, e.g., subject enrollment, data deliverables.
• Verifies proper management and accountability of Investigational Product (IP).
• Writes and submits reports of investigational site findings and updates applicable tracking systems. Escalates observed deficiencies, issues, and corrective and preventative action plans as appropriate.
• Manages essential documents as required by local regulations and ICH-GCP guidelines before, during, and after a clinical study; assists with resolution of investigational site/data queries.
• Performs key risk assessment and management responsibilities throughout the project, including key risk indicator and site health analysis, site process evaluation, and project escalation.
• Participates in audit preparation and follow-up activities as needed.
• Independently performs a variety of onsite and offsite monitoring visit types.
• Gathers and reviews information for assigned sites and identifies inconsistencies. With limited guidance from project and functional management, assesses risk and escalates as appropriate.
• Assists with non-complex ad hoc, short-term assignments in support of additional studies or departmental initiatives.
• May serve as preceptor, providing training to less experienced clinical team members

You are:

• 2 years of experience supporting clinical trials including 2 year of on-site monitoring experience
• In-depth knowledge of the drug development process
• In-depth knowledge and practical utilization of ICH- GCP and applicable regulatory requirements
• Sound knowledge of applicable policies and procedures, SOPs, work instructions and other guidance documents
• Good spoken and written communication skills; good presentation skills
• Strong interpersonal, collaboration and time management skills
• High proficiency with Microsoft Office and company collaboration applications
• Excellent skill in the utilization of applicable clinical systems
• Excellent critical thinking skills
• Excellent organizational skills
• Ability to focus on detail for extended periods of time; high attention to accuracy
• Ability to travel extensively
• Ability to establish and maintain effective working relationships with investigative site staff
• Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse
• Equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.

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. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our benefits examples include:

• 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

Visit our careers website to read more about the benefits of working at ICON:

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know through the form below.

-accommodations

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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