As a Clinical Research Associate you will be joining the world's largest & most comprehensive clinical research organization, powered by healthcare intelligence.
What you will be doing
* Implements and monitors clinical trials to ensure sponsor and investigator obligations are 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 closes clinical trials at investigative sites.
* Responsible for site startup activities for assigned sites, including but not limited to regulatory documents collection, informed consent review, IRB/IEC submission support, and budgets and contracts negotiations.
* Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely
* Provides regular site status information to team members, trial management, and updates trial management tools.
* Completes monitoring activity documents as required by sponsor\'s SOPs.
* Works closely with other clinical team members to facilitate timely resolution of trial and/or clinical issues.
* Escalates site and trial related issues per Sponsor\'s 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 serious adverse event (SAE) reporting according to trial specifications and ICH GCP guidelines.
* Communicates with investigative sites.
* Updates applicable tracking systems
* Ensures all required training is completed and documented.
* May be assigned to complex studies and/or sites.
* Provides leadership skills to assigned projects within the clinical operations department.
You Are
* A dedicated clinical research professional with an undergraduate degree in a clinical, scientific, or health-related field from an accredited institution — or equivalent relevant experience. A licensed healthcare professional (e.g., RN) is also acceptable.
* An experienced Clinical Research Associate with 2-5 years of clinical monitoring experience, including at least 1-2 years of on-site monitoring (vs all remote monitoring)
* Located in Texas near a major hub, with the ability to travel up to 50% of the time
* Experienced monitoring oncology trials; SCLC or NSCLC experience preferred but not required
* Proficient in feasibility assessments, site selection, and site start-up activities
* Familiar with or experienced in Phase 1 dose escalation studies (preferred)
* Comfortable supporting budget negotiations and resolving site-level challenges (preferred)
* Highly proactive, detail-oriented, and collaborative — a team player who takes initiative and communicates effectively
* Well-versed in ICH-GCP guidelines and applicable local regulatory requirements
* Able to lead observation and performance monitoring visits and act as a resource across functional teams to ensure study progress
* Skilled in managing tasks that require advanced negotiation and problem-solving
* Fluent in spoken and written English
* Legally authorized to work in the United States without requiring current or future employment visa sponsorship
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.
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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