Study Start Up Associate (Medical Device) - Hybrid - Arden Hills, MN - Arden Hills, MN
ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.
As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.
What you will be doing:
Through coordination with the Contract & Budget team, and collaboration with divisional and regional clinical teams, the SSU Associate II conducts clinical trial site start-up activities related to the preparation and approval of regulatory documents, ensuring they are conducted consistent with service level agreements, legal and regulatory standards, and applicable company policies and procedures. Specifically, these activities will include:
IRB submissions and approvals.
Site informed consent form (ICF) customizations & negotiations.
Essential regulatory document collection.
The SSU Associate II also provides support in enrollment, follow-up, and closure of clinical trial activities
Your responsibilities will include:
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.
What we are looking for in you:
Minimum Qualifications
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 Qualifications
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
Employment with ICON is contingent upon having the legal right to work in the country where the role is based.
Rewards & Benefits
ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.
Benefits may include:
Benefits may vary depending on role and location.
Visit our careers site to read more about the benefits ICON offers.
Inclusion and Accessibility
ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.
If you require reasonable accommodations during the recruitment process, please let us know or submit a request here
Salary Range
$62,376.00-$77,970.00
Are you a current ICON Employee? Please click here to apply
Since our foundation in Dublin, Ireland in 1990, our mission has been to help our clients to accelerate the development of drugs and devices that save lives and improve quality of life. We do this by delivering best in class information, solutions and performance, with an unyielding focus on quality at all times.
We offer a full range of consulting, development and commercialisation services from a global network of offices in 53 countries. We focus our innovation on the factors that are critical to our clients – reducing time to market, reducing cost, and increasing quality – and our global team of experts has extensive experience in a broad range of therapeutic areas.
