Senior Clinical Trial Associate - Home-Based (US)

As a Senior CTA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

This position has the responsibility to support the conduct of clinical trials, handling administrative aspects of clinical trial execution and tracking the progress of clinical trials. The position coordinates and tracks all study documentation including regulatory documents, study drug documents and clinical trial payments.

• Provide support in project-specific tasks and the overall management of clinical trials to theClinical 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
  • 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.
• Additional Responsibilities for a Sr CT
  • The Sr CTA may assist with vendor oversight and management, help identify issues in a timely manner and escalate to management as appropriate.
  • Conducts critical review and reconciliation of essential documents in TMF and independently manages TMF filing and management tasks.
  • Ensure timely completion of study tasks and update trial trackers on an on-going basis.
  • Audit of TMF
  • Other duties as assigned.

#LI-AS3

• 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:

• 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, 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.