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About the Role

ICON is a global healthcare intelligence and clinical research organisation focused on accelerating the delivery of new medicines and treatments to patients. This role implements and monitors clinical trials, ensuring compliance with regulatory requirements and ICH GCP guidelines.

Responsibilities

• 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, instructs site personnel, and closes clinical trials.
• Responsible for site startup activities, including regulatory document collection, informed consent review, IRB/IEC submission support, and budget/contract negotiations.
• Reviews and verifies accuracy of clinical trial data collected, either onsite or remotely.
• Provides regular site status information to team members and 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 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 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.
• Functions with little oversight.
• May serve as a subject matter expert for clinical operations on monitoring related activities.
• May be assigned to complex studies and/or sites.
• Provides leadership skills to assigned projects within the clinical operations department.

Requirements

• Highly responsive and proactive, team player.
• An undergraduate degree or its equivalent in a clinical, science, or health-related field from an accredited institution; a licensed healthcare professional (i.e., registered nurse) or equivalent work experience required.
• 2-5 years clinical monitoring experience required (CRA 2 for sponsor).
• 5+ years clinical monitoring experience required (Sr CRA for sponsor).
• Knowledge of ICH and local regulatory authority regulations regarding drug.
• Read, write, and speak fluent English.
• Oncology monitoring II/III experience required.
• Serves as observation and performance visit leader.
• Experience doing feasibility/site selection/site start up required.
• Budget negotiations experience preferred.
• May serve as a resource for and interact with other functional areas to resolve site issues and facilitate trial timelines.
• May be assigned clinical tasks where advanced negotiating skills are required.
• Applicants must be legally authorized to work in the United States and should not require, now or in the future, sponsorship for employment visa status.
• Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Skills

• Clinical monitoring
• Oncology monitoring
• ICH GCP guidelines
• Regulatory requirements
• Site startup
• Feasibility
• Site selection
• Budget negotiations
• Leadership

Location

• Central/East (NY/NJ or TX)

Work Type

• Full-time

Experience Level

• Senior
• 2-5 years
• 5+ years

Education Level

• Undergraduate degree or equivalent in clinical, science, or health related field
• Licensed healthcare professional (e.g., registered nurse)

Salary/Compensations

• $110,520.00-$138,150.00

Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

About the Company

• ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
• As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

Equal Opportunity

• ICON is an equal opportunity employer.
• We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
• If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.