New · posted Nov 12
ICON · Pharmaceuticals
Senior Clinical Research Associate
- Remote, US
- Remote
- Full-time
- Senior & Principal
The role
Senior Clinical Research Associate - Oncology - Southeast/Florida
At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON’s global expertise.
As the world’s largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.
What you need
- Bachelor’s degree (scientific field preferred)
- 5+ years monitoring clinical trials independently conducting on-site and remote monitoring visits. Atleast 2 years monitoring solid tumor clinical trials.
- 1+ years early development oncology trial experience and/or Phase III Oncology trial experience
- Solid tumor clinical trial experience is required
- Experience utilizing Veeva systems is highly preferred
- Demonstrated experience developing/maintaining site relationships and securing compliance
- Expertise in GxPs and Oncology monitoring techniques (including Risk-Based Monitoring) and terminology
- Experience collaborating with sites from initial engagement through close-out phases
- Experience activating sites
- Experience training site staff
- Experience supporting sites and/or sponsors in regulatory inspections
- Experience working within a Functional Services (or in-house) monitoring model is preferred
- Willing to travel up to 50%
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
What you'll do
- Perform site management activities to support the client's Oncology site success and maintain a continuous state of inspection readiness
- Act as the primary contact and facilitate efficient communications between the client's clinical trial team and the sites
- Perform remote and on-site monitoring/co-monitoring visits (Site Qualification Visits, Site Initiation Visits, Interim Monitoring Visits and Close-Out Visits) to ensure data integrity and subject safety in the client's trials
- May perform oversight activities to assess monitoring quality and train/mentor less experienced CRAs
- Promptly document monitoring activities and submit/approve visit reports
- Manage site essential document collection and TMF reconciliation with site files
- Support sites with local Institutional Review Board (IRB)/Ethics Committee (EC) submissions and confirm approvals
- Regularly review site Key Risk Indicator (KRI) metrics, issues and action items to detect trends and ensure prompt resolution
- Independently determine root causes and develop/implement site Corrective Action and Preventive Action (CAPA) plans
- Deliver training to ensure sites comply with the protocol, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs) and regulations
- Support sites and the client's regulatory inspections
- Contribute to site identification; drive site feasibility and qualification progress; and support site activation activities
- Lead site engagement initiatives and foster relationships with key Oncology sites and networks
Pay and benefits
ICON didn't publish pay for this role
See what similar roles pay on Regulatory Jobs, or try the salary calculator.
Rewards & 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
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Equal opportunity, accessibility and legal noticesICON's statements, word for word
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.
Are you a current ICON Employee? Please click here to apply
Job intelligence
The context around this role
Live data · November 12, 2026
Salary intelligence
How the pay compares
Senior & Principal roles in the US63 roles publishing pay
| Annual base pay | Low | Median | High |
|---|---|---|---|
| All US (middle half) | $117,000 | $124,500 | $126,750 |
Comparisons: the base pay employers published on open Clinical Research roles at the same level on Regulatory Jobs, November 12, 2026. Nothing is estimated.
Career trajectory
Where this role sits in Clinical Research
The general path across 249 open Clinical Research roles on Regulatory Jobs, with the titles they carry most. Not ICON's own promotion track.
Skills DNA
What this role leans on
How many of the posting's 30 duty, requirement and summary lines touch each area. The posting's emphasis, not a proficiency score.
- Clinical trial conduct9
- Collaboration and leadership7
- GMP and compliance5
- Documentation and SOPs3
- Validation and qualification2
- Data and digital systems2
- Lab testing and methods1
- Investigations and CAPA1
- Regulatory submissions1
Regulatory intelligence
The rules, regulations and standards behind this role
The regulations, guidance and standards that govern Clinical Research work in pharmaceuticals, led by the two this posting names, each linked to the agency or standards body that publishes it.
- ICHICH E6(R3) good clinical practice(official source, opens in a new tab)The international standard for the design, conduct and reporting of clinical trialsNamed in the posting
- FDA21 CFR Part 56(official source, opens in a new tab)Institutional review boards for FDA-regulated clinical investigationsNamed in the posting
- FDA21 CFR Part 312(official source, opens in a new tab)Investigational New Drug applications and sponsor duties in drug trials
- FDA21 CFR Part 50(official source, opens in a new tab)Protection of human subjects: informed consent in FDA-regulated trials
- FDAFDA Investigations Operations Manual(official source, opens in a new tab)How FDA investigators plan and conduct inspections
- EUEU Clinical Trials Regulation 536/2014(official source, opens in a new tab)How clinical trials of medicines are authorized and run in the EU, through CTIS
- ICHICH E8(R1)(official source, opens in a new tab)General considerations for clinical studies and quality by design in trials
- HHS45 CFR Part 46 (Common Rule)(official source, opens in a new tab)The federal policy for the protection of human research subjects
- NIH42 CFR Part 11(official source, opens in a new tab)Clinical trial registration and results reporting on ClinicalTrials.gov
- FDAFDA Bioresearch Monitoring (BIMO)(official source, opens in a new tab)FDA inspections of clinical investigators, sponsors, IRBs and GLP labs
- FDA21 CFR Part 11(official source, opens in a new tab)FDA rules for electronic records and electronic signatures
- HHSHIPAA Privacy Rule(official source, opens in a new tab)Federal protections for individually identifiable health information
- EUGDPR (Regulation 2016/679)(official source, opens in a new tab)The EU General Data Protection Regulation for personal data, including health data
- ICHICH E9 and E9(R1)(official source, opens in a new tab)Statistical principles for clinical trials and estimands
- FDA21 CFR 314.80 and 600.80(official source, opens in a new tab)Postmarketing reporting of adverse drug and biologic experiences
- ICHICH E2A to E2F(official source, opens in a new tab)Clinical safety data management, expedited reporting and periodic safety reports
Company hiring pulse
ICON on Regulatory Jobs
- 159
- Open roles
- 159
- Distinct roles
- 38
- Locations
By discipline
- Clinical152 92%
- Quality10 6%
- Regulatory4 2%
By level
- Associate & Specialist71 43%
- Senior & Principal66 40%
- Manager23 14%
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Senior Clinical Research Associate at ICON
Open until filled.