Clinical Research Associate – Oncology
ICON plc
full-time
Posted on:
Location Type: Remote
Location: Remote • Illinois, Montana, Texas • 🇺🇸 United States
Visit company websiteSalary
💰 $91,336 - $114,170 per year
Job Level
JuniorMid-Level
Tech Stack
Google Cloud Platform
About the role
- Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and International Conference on Harmonisation (ICH) Good Clinical Practice (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.
Requirements
- 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 2-3 years of clinical monitoring experience, including at least 1 year of on-site monitoring (vs all remote monitoring)
- Located in the Central region near a major hub, with the ability to travel up to 50% of the time (remote and on-site visits)
- 1 year Oncology experience strongly preferred; nephrology, hematology, immunology also acceptable (If no oncology experience, startup experience 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.
Benefits
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs.
- Competitive retirement planning offerings to maximize 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.
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
clinical trial monitoringsite startup activitiesregulatory document collectioninformed consent reviewIRB/IEC submissionsource document verificationadverse event reportingfeasibility assessmentsbudget negotiationsPhase 1 dose escalation studies
Soft skills
leadershipproactivedetail-orientedcollaborativeeffective communicationnegotiationproblem-solvingteam playerinitiativetask management
Certifications
licensed healthcare professionalRN