ICON Strategic Solutions · 1 week ago
Study Start Up Associate
Minneapolis, MN
Full-time
Hybrid
Entry, Mid Level
$70K/yr - $80K/yr
2+ years expICON plc is a world-leading healthcare intelligence and clinical research organization. The Study Start Up Associate II is responsible for conducting clinical trial site start-up activities, including the preparation and approval of regulatory documents, and supporting enrollment and closure of clinical trial activities.
Responsibilities
Work independently and proactively to coordinate all necessary activities for site regulatory submissions and essential document collection for allocated clinical research sites
Manage multiple sets of essential regulatory documents across several studies and division portfolios
Partner with clinical sites to support the negotiation and customization of Informed Consent Form (ICF)
Develop and foster clinical research site relationships to become a subject matter expert in the site start up regulatory process across multiple studies
Leverage knowledge of site regulatory processes and division priorities to meet clinical study goals and objectives
Manage to achieve target IRB/EC timelines by assisting clinical research sites with the application submission process and approval tracking
Manage and problem solve site start up challenges that arise to mitigate impact to service level agreement and study goals
Develop, prepare, complete and track required regulatory, ICF and legal documentation
Document clinical research site and investigator readiness for participation across multiple studies
Support internal quality audits, regulatory inspections, as applicable
Update and maintain study-specific startup and close out trackers
Update and maintain site specific metrics in Clinical Trial Management Systems, file and maintain site documents in eTMFs
Provide updates to leadership on site start up activities, investigator readiness, regulatory submission, approval status, etc
Escalate challenges and/or initiate outreach to Principal investigators, clinical research site coordinator, divisional clinical study leads and/or other stakeholders when appropriate
Ensure compliance with appropriate regulatory requirements (ICH/GCP, MDR, GDPR, etc.) and internal SOPs/WI, policies & procedures
Qualification
Required
Bachelor's Degree, or an equivalent combination of experience and education
2+ years' experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US
Ability to multi-task: support several studies and/or personnel simultaneously, work in a very fast-paced environment
Ability to work in a team environment and possess clear, concise communication & presentation skills – written and verbal
Must be comfortable interacting with clinical research site personnel via phone and email
Ability to work hybrid/on site in Arden Hills, MN campus
Preferred
Research Coordinator or In-House Clinical Research Associate / Clinical Research Associate / Study Start up specialist experience
Experience working with clinical trial management systems (e.g., Siebel CTMS, Veeva) and clinical document control systems / eTMF
Very high focus on Customer Service
Proficiency in English
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, 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.
Company
ICON Strategic Solutions
ICON Strategic Solutions is the global leading provider of Functional Service Provision (FSP) services.
10001+ employees
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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