Senior Clinical Research Associate - Cardio Device - MidWest/East Coast

ICON plc

80d

About The Position

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.

Requirements

• A bachelor's degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
• 5 years of monitoring experience will be considered.
• Electrophysiology/cardiac medical device monitoring experience preferred.
• Strong cardiology pharma monitoring experience or any background in electrophysiology will be considered.
• Candidates must have a well-executed plan for communication with the study teams and sites.
• Candidates must show collaboration and willingness to work within a team environment.
• Analytical/risk-based monitoring experience is an asset.
• Ability to actively drive patient recruitment strategies at assigned sites.
• Ability to partner closely with investigator and site staff to meet all study timelines.
• Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
• Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face.
• Strong team member and self-starter with the ability to work independently.
• In-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
• Ability to travel up to 65%.

Responsibilities

• Support 1-3 protocols in the cardiovascular/electrophysiology medical device space.
• 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.
• Act as primary company contact for assigned trial sites, engaging with Investigator and Site Staff throughout the life of the trial.
• Drive study compliance by executing activities within site initiation and start‐up, site monitoring, site management and site/study close‐out.
• Ensure site staff is trained, and the corresponding training records are complete and accurate.
• Contribute to site level recruitment strategy and contingency planning and implementation.
• Ensure site is equipped to carry out the trial with adequate site study supplies.
• Ensure quality data is provided by the site and queries resolved within expected timelines.
• Ensure trial subject safety in that all AEs/SAEs/UADEs/PQCs are reported within the required reporting timelines.
• Maintain complete, accurate and timely data and essential documents in systems utilized for trial management.
• Focus on Investigator engagement through timely follow up with sites.
• Complete follow‐up letter to communicate relevant information and required corrective action to the investigator.
• Promptly communicate relevant status information and issues to appropriate stakeholders.
• Collaborate with LTM/CTL for documenting and communicating site/study progress and issues.
• Work closely with LTM/CTL to ensure CAPA is completed for QA site audits and for quality issues identified at the site.
• Negotiate investigator budgets at site level, track costs and ensure payments are made at site level.
• Participate in the HA and IEC/IRB submission and notification processes as required.
• Contribute as a mentor to a less experienced site manager or to process improvement and training.
• Complete timely and accurate time reporting.

Benefits

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings.
• Global Employee Assistance Programme, offering 24-hour access to a global network of professionals.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Education Level: Bachelor's degree
• Number of Employees: 5,001-10,000 employees