As an experienced Senior Clinical Research Associate you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
- May serve as Lead CRA for specific study providing study level oversight and support for CRA's assigned to the study.
- This assignment ensure study level information is shared with assigned CRA's and has key role in establishing site monitoring strategy for study.
- Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
- Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
- Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
- Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
- Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
- Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
- Ensures site non-IMP study supplies are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
- Oversees the appropriate destruction of clinical supplies.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures validity and completeness of data collected at trial sites.
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
- Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Works closely with CTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
- Prepares trial sites for close out, conduct final close out visit.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
- May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within provided guidelines.
Senior CRA: 5 years of experience minimum
- May serve as Lead CRA for specific study providing study level oversight and support for CRA's assigned to the study.
- This assignment ensure study level information is shared with assigned CRA's and has key role in establishing site monitoring strategy for study.
- Responsible for driving activities within site initiation and start-up, preparation and conduct of site monitoring (including remote monitoring), site management (by study specific systems and other reports/dashboards) and site/study close-out according to SOPs, Work Instructions (WIs) and policies.
- Responsible for the implementation of risk based monitoring approaches at the site level and to work with site to ensure timely resolution of issues found during monitoring visits.
- Ensures site staff are trained and the corresponding training records are complete and accurate at any time point during all trial phases.
- Responsible in close collaboration with study team for the activities during site activation phase to speed up the process and activate the site in the shortest possible timeframe.
- Ensure site compliance with study protocol, ICH-GCP, and local/country regulations.
- Ensure ongoing adequacy of site (facilities, staff) for trial conduct.
- Ensure source and other site documentation is adequate and in compliance with ALCOA-CCEA
- Involved with site level recruitment strategy and prioritization and implementation in partnership with other functional areas.
- Ensures site non-IMP study supplies are adequate for trial conduct.
- Ensures that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and detailed.
- Oversees the appropriate destruction of clinical supplies.
- Ensures site staff complete data entry and resolve queries within expected timelines.
- Ensures validity and completeness of data collected at trial sites.
- Ensures that all Adverse Events (AE) /Serious Adverse Events (SAEs) are reported within the required reporting timelines and documented as appropriate.
- Maintains complete, accurate and timely data and essential documents in relevant systems used for trial management.
- Fully documents trial related activities, in particular monitoring. Writes visit reports and follow-up letter in accordance with the SOPs. Promptly communicates relevant status information and issues to appropriate stakeholders.
- Reviews study files for completeness and ensures archiving retention requirements are met, including storage in a secure area at all times.
- Aligns with relevant training requirements. Act as local expert in assigned protocols. Develops therapeutic knowledge sufficient to support role and responsibilities.
- Works closely with CTM to ensure Corrective Action Preventative Action (CAPA) is completed for Quality Assurance (QA) site audits and for quality issues identified at the site during routine monitoring visits.
- Prepares trial sites for close out, conduct final close out visit.
- Establishes and maintains good working relationships with internal and external stakeholders in particular investigators, trial coordinators and other site staff.
- May participate in the Health Authority (HA) and IEC/IRB submission and notification processes as required/appropriate.
- May be responsible for up to 10 sites across 2-4 protocols, dependent on complexity of protocols and site activity. Responsible for managing own travel budget within provided guidelines.
Experience required:
· BA/BS degree with ≥5years of experience in pharmaceutical related drug development or direct equivalent experience.
· Five years site monitoring and/or site management experience.
· A minimum of 2 years of Oncology, Ophthalmology, and/or Gene Therapy or other directly relevant therapeutic area experience.
· Strong working knowledge of GCP, local laws and regulations, assigned protocols and associated protocol specific procedures including monitoring guidelines.
· Strong critical thinking and problem solving skills.
· Strong IT skills in appropriate software and company systems.
· Willingness to travel up to 40% with overnight stay away from home.
· Proficient in speaking and writing English.
· Good written and oral communication.
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: 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, 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.
https://careers.iconplc.com/reasonable-accommodations
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.
