Clinical Research Associate - Oncology - Central Region (Field Based)

Clinical Research Associate - Oncology - Central Region (Field Based)

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development

What you will be doing:

• Implements and monitors clinical trials to ensure sponsor and investigator obligations are being met and are compliant with applicable local regulatory requirements and Internation 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.

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 2-3 years of clinical monitoring experience, including at least 1 year of on-site monitoring (vs all remote monitoring) 

• Located in Midwest 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

Pay Range ($91,336.00/Yr.USD - 114,170.00/Yr USD)

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.

What ICON can offer you:

Our success depends on the quality