Study Start Up Associate II - Medical Device

Study Start Up Associate
- Medical Device
- Home Based (US)

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.

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
.

• 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:

• Bachelor’s Degree, or an equivalent combination of experience and education.
• 3+ years’ experience in clinical/scientific research and medical device experience, specifically clinical study site start-up experience within the US.
  * Medical device industry experience is preferred but not required. Relevant clinical research certifications (e.g., CCRP, SOCRA) may be considered in lieu of direct medical device experience.
• Experience performing the core roles and responsibilities of a Trial Operations CRA within the pharmaceutical, biotechnology, or related clinical research industries would be considered.
• 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.
• Remote based position within the US

• 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…