As a CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What you will be doing:
Provide support in project-specific tasks and the overall management of clinical trials to the
Clinical Operations Department.
• Assist in the coordination, organization of study management team meetings, sponsor and site,
vendor teleconferences, including writing and distributing meeting minutes and agendas.
• Assist with the planning and logistics of formal meetings including investigator meetings.
• Help to develop and write SOPs for the Clinical Operations Department
• Assist in the maintenance of central files including maintaining version and quality control of
study documents submitted, assist in the file review of site clinical regulatory documentation to
confirm completeness/track dates and reconciliation for audits, and preparing study files for
archival.
• Ensures tracking of essential documents are received and filed in the TMF, reviews site
documents for accuracy; provides clinical team support with TMF filing and management.
• Order and maintain ancillary clinical study supplies required for conduct of clinical trials,
including copying, printing study documents, reference binders, and arrange shipping,
tracking, accordingly.
• Assist in the preparation and maintenance of Clinical Study Agreements and Confidentiality
Agreements.
• Assist with processing invoices from vendors Initiate request for investigator, site and vendor
payments.
• Enters and maintains study information in Clinical Trial Management System.
• May be assigned co-monitoring responsibilities; primarily local and occasional travel may be
required.
• Coordinates the review and setup of legal contracts, leases, purchase orders and other
agreements for company communicating attorney feedback to internal stakeholders, as needed.
• Maintains Contracts database along with physical customer contract files and subcontractor
agreements.
• Monitors contract status and communicates to internal stakeholders about contract renewals,
execution of rate increases, discounts related to revenue milestones and other contractual
obligations.
• Coordinates the review of RFP/Bid contract documents by company attorney and internal
stakeholders to identify possible issues related to language and/or commercial terms.
• Manages approval, execution and distribution of contracts, amendments and/or extensions of
contracts.
• Acts as liaison between the company, subcontractors and any/all interested parties to
contractual agreements
• Contract Management. Assistance the contracts manager as follows:
o Assistance with the processing of contracts and other documents for timely approval
and signature in accordance with company policies and procedures, including
proactively collaborating with stakeholders across the Company, tracking the progress
of approvals and signatures, and following up where appropriate. Assist in site payment
reconciliation activities ( pass through) , as needed.
You are:
Bachelor’s degree preferred. Preference in a health care or scientific discipline.
• Experience within clinical research or related experience in a pharmaceutical, biotechnology,
CRO and/or healthcare setting.
• Strong attention to detail and excellent organization skills.
• Strong interpersonal skills and communication skills (both written and oral) able to work
effectively in a team/matrix environment.
• Excellent verbal, written communication and presentation skills are required.
• Experience using Office 365 (Word, Excel, Power Point) applications and SharePoint
• Experience with IXRS and EDC systems a plus.
• Knowledge of clinical research operations, FDA Regulations, ICH Guidelines, and GCPs governing
the conduct of clinical trials.
• Must be able to prioritize multiple tasks, plan proactively, and accomplish goals using well
defined instructions and procedures.
• Ability to develop tools and processes that increase measured efficiencies of the project.
• Experience in gene therapy and/or rare disease indications preferred
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:
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
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 organisation. 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.
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.
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