Study Start-up Associate II

ICON Strategic Solutions; Town of Poland (NY); On-site; USD 70,000 - 90,000; Full time

Benefits offered by this job

Annual leave entitlements

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Life assurance

Childcare vouchers

Job summary

ICON plc in the United States seeks a Study Start Up Associate II to support site start up and activation activities, coordinating with internal teams and external sites to meet study timelines.

You will review site documents (ICFs, CVs, 1572), assist with ICF approvals, and track actions to ensure timely activation across projects. Strong organizational and communication skills are essential.

Qualifications

• BS degree or international equivalent.
• 2+ years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and essential documents
• Strong organizational skills, decision making, communication and negotiation skills
• Proficient in Microsoft Excel, Word, and PowerPoint.

Responsibilities

• Work directly with assigned sites on all site related essential document collection and review.
• Work with sites to review and approve site level ICFs.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
• Ensure standards are applied to the SSU processes across projects.
• Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
• Promptly recognize and improve potential site activation delays and elevate to appropriate team members.
• Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
• Review and provide feedback to management on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites during start up

Skills

Data-driven decisions

Organizational skills

Communication

Negotiation

Education

BS degree or international equivalent

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

POL-SSUA II - HB

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.

As a Study Start Up Associate II at ICON, you will support the facilitation of site start up and communication with internal and external team members to ensure prompt site approval and study timelines are achieved.

Support sites and study teams to achieve rapid site start up.

What You Will Do

You will contribute to site start-up and activation activities, taking responsibility for your deliverables and working collaboratively.

Key Responsibilities Include

• Work directly with assigned sites on all site related essential document collection and review.
• Work with sites to review and approve site level ICFs.
• Partner with internal Study Startup team, CROs, Clinical Operations teams, and TAU partners to improve overall SSU metrics and deliver processes.
• Ensure standards are applied to the SSU processes across projects.
• Review site essential documents for start up including but not limited to: ICF, FDF, 1572, CVs etc
• Promptly recognize and improve potential site activation delays and elevate to appropriate team members.
• Track all actions and communications with sites to ensure timelines are achieved for studies and sites assigned.
• Support resolving escalated issues identified by the CROs and Clinical Operations teams in partnership with the internal Study Startup team.
• Review and provide feedback to management on site performance metrics.
• Ensure accuracy and completeness of the eTMF for assigned sites during start up

Your Profile

You will bring relevant site start-up and activation experience, along with the following qualifications and skills.

Required Qualifications And Experience

• BS degree or international equivalent
• 2 or more years of experience in clinical research Site Start Up within a pharmaceutical company, CRO or relevant industry vendor.
• Ability to explain data to facilitate decision making processes to be data driven.
• Knowledge and understanding of clinical study protocols and essential documents
• Strong organizational skills, decision making, communication and negotiation skills
• Proficient in Microsoft Excel, Word, and PowerPoint.

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 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.

Visit our careers site to read more about the benefits ICON offers.

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, 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 or submit a request here