Senior Clinical Research Associate - Cardio Device - US Regional

Senior Clinical Research Associate - Cardio Device - US Home Based

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.

We are currently seeking a Senior Clinical Research Associate (CRA) to join our diverse and dynamic team. As a Senior CRA at ICON Plc, you will play a critical role in overseeing and managing clinical trial activities to ensure they are conducted according to protocol, regulatory requirements, and industry standards. You will contribute to the success of clinical trials by ensuring data integrity, participant safety, and compliance throughout the study lifecycle.

What will you be doing?

To support 1-3 protocols in the cardiovascular / electrophysiology medical device space.

What will you be doing?

• Services rendered will adhere to applicable client SOPs, WIs, policies, local regulatory requirements, etc.
• Contribute to quality Site Selection through participation in site feasibility and / or pre ‐ trial site assessment visits, providing recommendation from local area about site / investigator selection in collaboration with the trial team.
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial (investigator meetings, site visits, quality communication, etc.).
• Drive study compliance by executing activities within site initiation and start ‐ up, site monitoring, site management and site / study close ‐ out according to internal SOPs / WIs / IFUs and policies.
• Ensures site staff is trained, and the corresponding training records are complete and accurate at any time point during all trial phases.
• Contribute to site level recruitment strategy and contingency planning and implementation in partnership with other functional areas to achieve clinical research target.
• Ensures site is equipped to carry out the trial with adequate site study supplies (such as Non ‐ IP, lab kits, etc.) and clinical drug / device / biologic supplies. This will include oversight of proper handling, storage and return and / or destruction with accurate inventory maintained / documented.
• Ensures quality data (accurate, valid and complete) is provided by the site and queries resolved within expected timelines.
• Ensures trial subject safety in that all AEs / SAEs / UADEs / PQCs are reported within the required reporting timelines and documented as appropriate, with supporting data collected and verifiable with information in the source documents.
• Ensures Inspection readiness for sites by maintaining complete, accurate and timely data and essential documents in systems utilized for trial management (e.g. CTMS and eTMF / IF) according to expectations (metrics) and archiving retention requirements, including storage in a secure area at all times.
• Focuses on Investigator engagement through timely follow up with sites. Completes follow ‐ up letter to communicate relevant information and required corrective action to the investigator and his / her team with required timeframes. Promptly communicates relevant status information and issues to appropriate stakeholders. Follows the corresponding Project Operations Manual (POM) / Monitoring Guidelines for each assigned trial.
• Collaborates with LTM / CTL for documenting and communicating site / study progress and issues to trial central team.
• Keeps oneself inspection ready and knowledgeable for current work by complying with relevant training requirements and developing therapeutic knowledge sufficient for role and responsibilities.
• Works closely with LTM / CTL to ensure CAPA is completed for QA site audits and for quality issues identified at the site during routine monitoring and other visit types, e.g. On Site Quality Monitoring Visit (OSQMV).
• If applicable, will negotiate investigator budgets at site level, track costs and ensure payments are made at site level, maintaining site relationships.
• May participate in the HA and IEC / IRB submission and notification processes as required / appropriate.
• May contribute as a mentor to a less experienced site manager or to process improvement and training, as appropriate for business needs.
• Full utilization by timely and accurate time reporting.
• If applicable, region specific deliverables will be specified.
• Advanced :

Autonomy in execution of site management services

What you need to have :

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 :

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

Interested in the role, but unsure if you meet all of the requirements? We would encourage you to apply regardless – there’s every chance you’re exactly what we’re looking for here at ICON whether it is for this or other roles.

Are you a current ICON Employee? Please click here to apply