ICON Strategic Solutions
Senior Regional Clinical Research Associate
ICON Strategic Solutions, Hartford, Connecticut, United States
Overview
Senior Regional Clinical Research Associate role focusing on qualification, initiation, monitoring, and close-out visits in accordance with study protocols and ICH-GCP guidelines. The successful candidate will protect the rights, safety, and well-being of study participants, verify data accuracy at investigative sites, collaborate with site staff and cross-functional teams, maintain audit-ready documentation, and provide training and support to site personnel. This role includes monitoring complex Phase 1 oncology trials (dose-escalation, first-in-human, and combination therapy protocols). Responsibilities
Conduct qualification, initiation, monitoring, and close-out visits in accordance with study protocols and ICH-GCP guidelines Ensure the rights, safety, and well-being of study participants Verify the accuracy and completeness of data collected at investigative sites Collaborate closely with site staff and cross-functional teams to proactively identify and resolve study-related issues Ensure all study documentation is accurate, up-to-date, and audit-ready Provide training and support to site personnel on study procedures and regulatory requirements Monitor complex Phase 1 oncology trials, including dose-escalation, first-in-human, and combination therapy protocols High-impact role suitable for professionals with strong clinical monitoring skills, keen attention to detail, and a passion for advancing oncology research 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 5+ years of clinical monitoring experience Located in the southeast region with the ability to travel up to 50% of the time Experienced in oncology trials; SCLC or NSCLC experience preferred but not 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 What ICON can offer you
Our success depends on the quality of our people. We’ve built a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family. Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise 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 Visit our careers website to read more about the benefits of working at ICON: careers.iconplc.com/benefits Equal opportunity
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know. Reasonable accommodations: careers.iconplc.com/reasonable-accommodations How to apply
Interested in the role? Apply regardless – there’s every chance you’re exactly what ICON is looking for here at ICON, whether it is for this or other roles.
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Senior Regional Clinical Research Associate role focusing on qualification, initiation, monitoring, and close-out visits in accordance with study protocols and ICH-GCP guidelines. The successful candidate will protect the rights, safety, and well-being of study participants, verify data accuracy at investigative sites, collaborate with site staff and cross-functional teams, maintain audit-ready documentation, and provide training and support to site personnel. This role includes monitoring complex Phase 1 oncology trials (dose-escalation, first-in-human, and combination therapy protocols). Responsibilities
Conduct qualification, initiation, monitoring, and close-out visits in accordance with study protocols and ICH-GCP guidelines Ensure the rights, safety, and well-being of study participants Verify the accuracy and completeness of data collected at investigative sites Collaborate closely with site staff and cross-functional teams to proactively identify and resolve study-related issues Ensure all study documentation is accurate, up-to-date, and audit-ready Provide training and support to site personnel on study procedures and regulatory requirements Monitor complex Phase 1 oncology trials, including dose-escalation, first-in-human, and combination therapy protocols High-impact role suitable for professionals with strong clinical monitoring skills, keen attention to detail, and a passion for advancing oncology research 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 5+ years of clinical monitoring experience Located in the southeast region with the ability to travel up to 50% of the time Experienced in oncology trials; SCLC or NSCLC experience preferred but not 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 What ICON can offer you
Our success depends on the quality of our people. We’ve built a diverse culture that rewards high performance and nurtures talent. In addition to a competitive salary, ICON offers a range of benefits designed to be competitive within each country and focused on well-being and work-life balance opportunities for you and your family. Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximise 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 Visit our careers website to read more about the benefits of working at ICON: careers.iconplc.com/benefits Equal opportunity
At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON is committed to providing a workplace free of discrimination and harassment. All qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please let us know. Reasonable accommodations: careers.iconplc.com/reasonable-accommodations How to apply
Interested in the role? Apply regardless – there’s every chance you’re exactly what ICON is looking for here at ICON, whether it is for this or other roles.
#J-18808-Ljbffr