Senior Clinical Trial Associate - Hybrid Office-Based in Waltham, MA

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re proud to foster an inclusive environment driving innovation and excellence, and we welcome you to join us on our mission to shape the future of clinical development.

Position Overview:

• Project support: Responsible for coordination, tracking and management of logistics in support of clinical trials. Operational support: Responsible for special projects supporting departmental operations.

• Clinical study team member: works closely with the Clinical Trial Manager (CTM) and is responsible for coordination, tracking, and management of logistics in support of clinical trials.
• Responsible for tracking study budgets, including invoice and PO management/reconciliation, month end actuals and accruals in support of the CTM and Finance. Also responsible for investigator and vendor payments for in-house studies.
• Works closely with CTM and legal to review and approve clinical trial agreements and site specific study budgets.
• Tracks study status, enrollment, regulatory documentation, and site start-up status for assigned clinical projects including review and approval of regulatory package for release of clinical supply.
• Reviews clinical trial documentation including monitoring visit reports, monitoring plans, communication plans, timelines, etc.
• Responsible for set-up, maintenance, reconciliation, and archiving of electronic and paper Trial Master Files.  Coordinates TMF transfer with CROs.
• Responsible for data entry, database maintenance, and reporting in Clinical Trial Management Systems.
• Maintains access rights to Clinical Trial Management Systems.
• Interacts with CROs, vendors, investigators, monitors and other external partners to provide information and resolution for specific study requests and issues.
• Works with CRO and Study Start-Up (SSU)  to collect and review essential regulatory documents prior to site initiation/study drug release.
• Assists CTM in review of study plans.
• Assists CTM in review and approval of informed consent templates.
• Participates in user acceptance testing (UAT) for EDC/IWRS.
• Manages and coordinates logistics for clinical and non-clinical supplies.
• Responsible for agendas and meeting minutes for clinical study team meetings.
• Manages logistics and coordinates investigator meetings, CRO kick-off meetings, and vendor meetings along with CTM and external meeting planners.
• Responsible for routing, tracking, and coordinating site and CRO/vendor Confidential Disclosure Agreements (CDAs), contracts and change orders with Associate Director Clinical Operations, legal, and finance departments.
• Responsible for facilitating site advertisement review and approval with CCC Committee.
• Mentors and trains CTAs and new hires on departmental procedures and systems.
• Responsible for special projects supporting operations/departmental initiatives such as ClinicalTrials.gov, SOPs, GCP, process enhancements, outsourcing, Sunshine Act, systems implementation, training, etc.

Education/Skills and Experience Requirements:

• Bachelor’s degree or equivalent undergraduate degree with science or healthcare experience
• Experience: minimum 3-5 years clinical research experience in a pharmaceutical/biotech, CRO setting
• Solid knowledge and understanding of GCP/ICH Guidelines for conducting clinical trials
• Strong interpersonal, organizational, and multi-tasking skills
• Excellent attention to detail and problem solving skills
• Self-motivated and displays initiative
• Perform job duties with minimal supervision and guidance
• Ability to work effectively work in a team setting

Physical Demands and Work Environment:

• Travel domestic and international – up to 10%

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/benefitsAt 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-accommodationsInterested 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.

**Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.**