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.
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 Harmonization (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.
Functions with little oversight (Sr level)
May serve as a subject matter expert for clinical operations on monitoring related activities (Sr level)
May be assigned to complex studies and/or sites.
Provides leadership skills to assigned projects within the clinical operations department.
What you need to have:
Highly responsive and proactive, team player
An undergraduate degree or it’s equivalent in clinical, science, or health related field from an accredited institution; a licensed health care professional (i.e. registered nurse) or equivalent work experience required.
5+ years clinical monitoring experience required (Sr CRA)
Knowledge of ICH and local regulatory authority regulations regarding drug
Read, write and speak fluent English.
Oncology Phase II/III monitoring 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.
To qualify, 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.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
- 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
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
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.
Salary Range
$110,520.00-$138,150.00Are you a current ICON Employee? Please click here to apply
Skills Required
- Undergraduate degree in clinical, science, or health field OR licensed healthcare professional (e.g., RN) or equivalent experience
- 5+ years clinical monitoring experience
- Oncology Phase II/III monitoring experience
- Knowledge of ICH GCP and local regulatory authority regulations
- Experience with feasibility, site selection, and site start-up activities
- Experience serving as observation and performance visit leader
- Read, write, and speak fluent English
- Authorization to work in the United States without sponsorship
- Budget negotiations experience
ICON plc Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about ICON plc and has not been reviewed or approved by ICON plc.
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Healthcare Strength — Benefits are described as comprehensive, with medical coverage and wellness initiatives highlighted. Larger sites are also associated with added wellness supports such as onsite fitness options and access to an employee assistance program.
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Leave & Time Off Breadth — Time-off and flexibility provisions are positioned as a meaningful part of the total package, including vacation/annual leave and flexible work scheduling. Flexibility is sometimes cited as helping offset long hours in certain roles.
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Retirement Support — Retirement and savings support is presented as a core component of the benefits package, including offerings such as pension arrangements in some locations and a U.S. 401(k) plan with company match. Financial planning resources are also emphasized as part of broader security benefits.
ICON plc Insights
What We Do
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times. We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
