PRA International
Job Title Clinical Trial Associate
PRA International, Location, West Virginia, United States,
OverviewAs a CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
ResponsibilitiesWhat you will be doing:
Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines.
Assist in the creation and updating of informed consent forms, study manuals and tools.
Assist in performing monitoring report review, aggregation and tracking of findings and trends.
Assist in and support trainings of CROs and sites (e.g., SIVs and other training activities).
Participate in user acceptance testing (UAT) for clinical systems (e.g., EDC, IRT, etc).
Participate in clinical supply tracking and forecasting, with oversight by the COL/COM.
Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems.
Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs.
Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to Moderna systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff).
Participate, with oversight by the COL/CTM, in clinical data review for assigned studies.
Act as a facilitator for Clinical Trial Team meetings and other internal meetings, working with the COL/CTM to craft agendas, minutes and conduct the meeting.
Assist with vendor/clinical site agreements, budgets and reconciliation/tracking of purchase orders and invoices for assigned trials.
Participate in workstreams and initiatives related to clinical development and clinical operations operating model and infrastructure building.
Develop and maintain strong, collaborative relationships with key stakeholders within the Client, its CROs, and clinical sites.
Participate in mentoring/onboarding of other CTAs within clinical operations.
Strive for continuous improvement and more efficient ways of working in clinical development.
QualificationsYou are:
At least 2 years of experience in a clinical research environment.
Bachelor’s degree in a science-based discipline preferred.
Basic understanding of drug development, including familiarity with FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
Good verbal and written communication skills.
Good organizational skills and attention to detail.
Willingness to learn, able to take direction and ability to manage multiple tasks.
Self-motivated and comfortable with shifting priorities and change in a small company environment.
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 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.
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ResponsibilitiesWhat you will be doing:
Assist the Clinical Operations Lead(s) (COL) and/or Clinical Trial Manager(s) (CTM) in the day-to-day operational activities of assigned trials to ensure study objectives and timelines are met with quality, in compliance with applicable SOPs and regulatory guidelines.
Assist in the creation and updating of informed consent forms, study manuals and tools.
Assist in performing monitoring report review, aggregation and tracking of findings and trends.
Assist in and support trainings of CROs and sites (e.g., SIVs and other training activities).
Participate in user acceptance testing (UAT) for clinical systems (e.g., EDC, IRT, etc).
Participate in clinical supply tracking and forecasting, with oversight by the COL/COM.
Maintain clinical trial files (including eTMF), project processes, tracking systems, and other utilized study or departmental systems.
Liaise with Clinical Sample Management for the tracking and coordination of biomarker testing with 3rd party labs.
Collaborate with Clinical Data Management and Digital Informatics to ensure timely training and access to Moderna systems (e.g., EDC, IWRS, ePRO, eTMF) for external stakeholders (e.g., CRO and Clinical Site Staff).
Participate, with oversight by the COL/CTM, in clinical data review for assigned studies.
Act as a facilitator for Clinical Trial Team meetings and other internal meetings, working with the COL/CTM to craft agendas, minutes and conduct the meeting.
Assist with vendor/clinical site agreements, budgets and reconciliation/tracking of purchase orders and invoices for assigned trials.
Participate in workstreams and initiatives related to clinical development and clinical operations operating model and infrastructure building.
Develop and maintain strong, collaborative relationships with key stakeholders within the Client, its CROs, and clinical sites.
Participate in mentoring/onboarding of other CTAs within clinical operations.
Strive for continuous improvement and more efficient ways of working in clinical development.
QualificationsYou are:
At least 2 years of experience in a clinical research environment.
Bachelor’s degree in a science-based discipline preferred.
Basic understanding of drug development, including familiarity with FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies.
Good verbal and written communication skills.
Good organizational skills and attention to detail.
Willingness to learn, able to take direction and ability to manage multiple tasks.
Self-motivated and comfortable with shifting priorities and change in a small company environment.
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 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.
#J-18808-Ljbffr