PRA HEALTH SCIENCES
Clinical Research Associate - Oncology -California/West
PRA HEALTH SCIENCES, California, Missouri, United States, 65018
Overview
As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities
What will you be doing? Works on multiple oncology trials Quality of life focus with Regional Travel Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes Mentors/coaches junior flex team Acts as Lead SM-training other SMs on study Develops site start-up documents for studies including SIV agenda Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines) Represents LTMs or SMs on SMTs/meetings Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial Supports country budget development and/or contract negotiation in liaison with CCS colleagues Assists with ASV Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces – Primary/Other: Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, and Central Study Team for assigned clinical trials. Other Interfaces: Study Responsible Physician, Regional Quality and Compliance Manager/Specialist, Local Drug Safety Officer (where required), and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.) Qualifications
Qualifications Needed: Based in California near a major airport; alternatively AZ, OR/WA, CO near a major airport. Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences Have a minimum of 2 years’ experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring Oncology trials Knowledge of several therapeutic areas, with oncology an asset but not a requirement. Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements. Need to travel up to 50% To qualify, applicants must be legally authorized to work in the US, and should not require, now or in the future, sponsorship for employment visa status Pay Range ($89,376.00 USD – $111,720.00 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 of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead Global Employee Assistance Programme, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON. At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organization. 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 through the form below. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
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As a Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. Responsibilities
What will you be doing? Works on multiple oncology trials Quality of life focus with Regional Travel Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes Mentors/coaches junior flex team Acts as Lead SM-training other SMs on study Develops site start-up documents for studies including SIV agenda Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines) Represents LTMs or SMs on SMTs/meetings Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial Supports country budget development and/or contract negotiation in liaison with CCS colleagues Assists with ASV Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document. Interfaces – Primary/Other: Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, and Central Study Team for assigned clinical trials. Other Interfaces: Study Responsible Physician, Regional Quality and Compliance Manager/Specialist, Local Drug Safety Officer (where required), and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.) Qualifications
Qualifications Needed: Based in California near a major airport; alternatively AZ, OR/WA, CO near a major airport. Have a minimum of a B.Sc., R.N., or equivalent degree, preferably in Biological Sciences Have a minimum of 2 years’ experience in monitoring pharmaceutical industry clinical trials Have a minimum of 1-3 years' experience monitoring Oncology trials Knowledge of several therapeutic areas, with oncology an asset but not a requirement. Analytical/risk-based monitoring experience is an asset Ability to actively drive patient recruitment strategies at assigned sites Ability to partner closely with investigator and site staff to meet all study timelines Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting). Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face. Strong team member and self-starter with the ability to work independently. Have an in-depth knowledge of Good Clinical Practice, ICH guidelines, and local regulatory requirements. Need to travel up to 50% To qualify, applicants must be legally authorized to work in the US, and should not require, now or in the future, sponsorship for employment visa status Pay Range ($89,376.00 USD – $111,720.00 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 of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent. In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work-life balance opportunities for you and your family. Our benefits examples include: Various annual leave entitlements A range of health insurance offerings to suit you and your family’s needs Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead Global Employee Assistance Programme, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others Visit our careers website to read more about the benefits of working at ICON. At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organization. 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 through the form below. Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.
#J-18808-Ljbffr