ICON Strategic Solutions · 2 days ago
Senior CTA
United States
Full-time
Remote
Senior LevelICON plc is a world-leading healthcare intelligence and clinical research organization, and they are seeking a Senior Clinical Trial Associate to support the conduct of clinical trials. The role involves handling administrative aspects of clinical trial execution and tracking the progress of clinical trials, while coordinating study documentation and assisting with project-specific tasks.
Pharmaceuticals
Responsibilities
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 communicate 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
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
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
Qualification
Required
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
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
Preferred
Experience in gene therapy and/or rare disease indications preferred
Experience with IXRS and EDC systems a plus
Benefits
Various annual leave entitlements
A range of health insurance offerings to suit you and your family’s needs.
Competitive retirement planning offerings to maximize savings and plan with confidence for the years ahead.
Global Employee Assistance Programme, LifeWorks, offering 24-hour access to a global network of over 80,000 independent specialized 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, subsidized travel passes, health assessments, among others.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
H1B Sponsorship
ICON Strategic Solutions has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2023 (1)
2022 (1)
2021 (2)
2020 (3)
Funding
Current Stage
Late StageLeadership Team
Jennifer Alamo Linnell
VP, HR Business Partnering
Aimée Guzmán
External Partnerships Project Manager & Site Lead | Providing Services for J&J Innovative Medicines
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