Study Start-up Associate II

ICON Clinical Research; Poland; Remote; PLN 120,000 - 160,000; Full time

Benefits offered by this job

Annual leave

Health insurance

Retirement planning

LifeWorks EAP

Life assurance

Country-specific benefits

Job summary

ICON plc is a world-leading healthcare intelligence and clinical research organization. We’re looking for a Study Start-up Associate II in Poland to support rapid site start up and coordinate with internal and external teams to meet timelines.

You will work with sites on essential document collection, partner with internal Study Startup teams, CROs, Clinical Operations, and TAU partners to improve SSU metrics and ensure eTMF accuracy during startup.

Qualifications

• BS degree or international equivalent.
• 2+ years of experience in clinical research Site Start Up.
• Ability to explain data to facilitate decision making.
• Knowledge of clinical study protocols and essential documents.
• Strong organizational, communication and negotiation skills.
• Proficient in Microsoft Excel, Word, and PowerPoint.

Responsibilities

• Support sites and study teams to achieve rapid site start up.
• Work with assigned sites on essential document collection and review.
• Partner with internal Study Startup team, CROs, Clinical Operations to improve SSU metrics.
• Ensure standards are applied to SSU processes across projects.
• Review site essential documents (ICF, 1572, CVs, etc.).
• Track actions and communications to meet study/site timelines.
• Support resolving escalated issues with CROs and internal teams.
• Review and provide feedback on site performance metrics.
• Ensure accuracy and completeness of the eTMF for sites during start up.

Skills

Data-driven decision making

Organizational skills

Communication skills

Negotiation skills

Education

BS degree or international equivalent

Tools

Microsoft Excel

Microsoft Word

PowerPoint

Job description

POL-HB-Contract

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.

What You Will Do:

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

Key responsibilities include:

• Work directly with assigned sites on all site related essential document collection and review.
• 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 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 (https://careers.iconplc.com/benefits) 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 (https://careers.iconplc.com/reasonable-accommodations)