ICON Strategic Solutions
Overview
Join to apply for the
Senior CRA- TX
role at
ICON Strategic Solutions . As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What You Will Be Doing
Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity Strong planning & organizational skills, and the ability to work efficiently and effectively Proactive, conscientious and precise in delivery of quality work even when under pressure Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely manner Flexible with high learning and change agility Knowledge of local regulations, IND/ICH GCP guidelines Available and willing to travel as job requires Communicate progress and relevant information or escalate issues of the study to the appropriate study management team Engage and maintain good written and verbal communication with external stakeholders to ensure effectiveness Accountable for local activities required in setup and for high quality execution of studies; will seek managerial or other experienced support as appropriate Performs operational site evaluation visits, study initiation visits, on- and off-site monitoring visits at the required frequency and site close-out Determines the feasibility of the study protocol with reference to study complexity Confirms staff availability, suitable clinical facilities, and potential for per protocol patient population Confirms ability to comply with ICH GCP and requirements for clinical studies Works with study staff to carry out a local study/site level risk assessment Participates in global investigators and/or monitor meetings as appropriate; facilitates investigator participation in global meetings and/or may assist study staff with organizing local investigator meetings Maintains good relationships with sites and ensures critical study timelines related to monitoring activities are achieved and that recruitment targets, data and audit quality and site-related milestones are met Ensures investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP) Works with sites to address data queries in a timely manner; verifies that data entered into CRFs is consistent with patient medical notes and entered in real time Ensures Investigator and site staff receive safety reports and new safety information in a timely manner Ensures the accuracy of data collected for safety reporting (AEs, SAEs, etc.), and provides such information to safety department and other relevant departments within required time frames Completes monitoring visit reports within the agreed timelines Ensures local and global clinical study tracking databases are kept current with clinical study information as required (e.g., e-track, Veeva, RAMOS) Ensures all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained; ensures unused supplies are accounted for and destroyed appropriately Ensures sponsor study records are inspection-ready at all times and archives records as applicable You Are
Education required
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (e.g., registered nurse) or equivalent work experience preferred Skills Required
Read, write and speak fluent English; fluent in host country language required 4+ years of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drugs Clinical research experience Experience in monitoring all trial components (PSSV to COV) Experience in coaching/mentoring other CRAs 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 for you and your family. 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 Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of professionals 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: https://careers.iconplc.com/benefits 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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you need reasonable accommodation for any part of the application process or to perform essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing
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Join to apply for the
Senior CRA- TX
role at
ICON Strategic Solutions . As a Senior CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence. What You Will Be Doing
Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity Strong planning & organizational skills, and the ability to work efficiently and effectively Proactive, conscientious and precise in delivery of quality work even when under pressure Effective at analyzing and escalating issues at the right functional level, solving problems and resolving conflicts in a timely manner Flexible with high learning and change agility Knowledge of local regulations, IND/ICH GCP guidelines Available and willing to travel as job requires Communicate progress and relevant information or escalate issues of the study to the appropriate study management team Engage and maintain good written and verbal communication with external stakeholders to ensure effectiveness Accountable for local activities required in setup and for high quality execution of studies; will seek managerial or other experienced support as appropriate Performs operational site evaluation visits, study initiation visits, on- and off-site monitoring visits at the required frequency and site close-out Determines the feasibility of the study protocol with reference to study complexity Confirms staff availability, suitable clinical facilities, and potential for per protocol patient population Confirms ability to comply with ICH GCP and requirements for clinical studies Works with study staff to carry out a local study/site level risk assessment Participates in global investigators and/or monitor meetings as appropriate; facilitates investigator participation in global meetings and/or may assist study staff with organizing local investigator meetings Maintains good relationships with sites and ensures critical study timelines related to monitoring activities are achieved and that recruitment targets, data and audit quality and site-related milestones are met Ensures investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP) Works with sites to address data queries in a timely manner; verifies that data entered into CRFs is consistent with patient medical notes and entered in real time Ensures Investigator and site staff receive safety reports and new safety information in a timely manner Ensures the accuracy of data collected for safety reporting (AEs, SAEs, etc.), and provides such information to safety department and other relevant departments within required time frames Completes monitoring visit reports within the agreed timelines Ensures local and global clinical study tracking databases are kept current with clinical study information as required (e.g., e-track, Veeva, RAMOS) Ensures all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained; ensures unused supplies are accounted for and destroyed appropriately Ensures sponsor study records are inspection-ready at all times and archives records as applicable You Are
Education required
Undergraduate degree or its international equivalent in clinical, science, or health-related field from an accredited institution; a licensed health-care professional (e.g., registered nurse) or equivalent work experience preferred Skills Required
Read, write and speak fluent English; fluent in host country language required 4+ years of clinical monitoring experience required Knowledge of ICH and local regulatory authority regulations regarding drugs Clinical research experience Experience in monitoring all trial components (PSSV to COV) Experience in coaching/mentoring other CRAs 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 for you and your family. 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 Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of professionals 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: https://careers.iconplc.com/benefits 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, colour, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status. If you need reasonable accommodation for any part of the application process or to perform essential functions of a position, please let us know through the form below. https://careers.iconplc.com/reasonable-accommodations Interested in the role, but unsure if you meet all of the requirements? We encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON. Additional Details
Seniority level: Mid-Senior level Employment type: Full-time Job function: Research, Analyst, and Information Technology Industries: Pharmaceutical Manufacturing
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