Senior Clinical Research Associate

As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

We are currently recruiting for a Senior CRAs in Romania to work on oncology studies for a prestigious and global biopharmaceutical company.  This particular SrCRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs.

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.

What you will be doing:

• You will monitor multiple Phase II, III & IV clinical trial sites in oncology. Assist other CRAs with co-monitoring activities both remote and on-site.
• May support new CRA training
• Functions independently with minimal oversight required.
• May serve as subject matter expert for clinical operations on monitoring-related activities.
• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and ICH GCP guidelines.
• 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.
• Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
• 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.
• Updates applicable tracking systems.
• Serves as main observer/assessor of site activities.
• Facilitates audits and audit resolution.

Requirements:

• 4 or more years of clinical on-site monitoring experience required.
• Experience in monitoring all trial components (pre-study site visit [PSSV] to closeout visit [COV]) preferred.
• Experience in monitoring complex trials preferred.
• Oncology experience preferred.
• University degree in clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (ie, registered nurse); or equivalent work experience required.
• Read, write, and speak fluent English; fluent in host country language required.
• 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. 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: https://careers.iconplc.com/benefits

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. 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, color, 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.

https://careers.iconplc.com/reasonable-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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