As a Sr CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
What will you be doing?
To support 1 protocol 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
- Depth of knowledge with site management services
- Process leadership
What you need to have:
- A Bachelor Degree is required, preferably a Bachelor of Science Degree in Life Science, Physical Science, Nursing or Biological Science.
- Associates Degree with 5+ years of monitoring experience will be considered. 4-year degree preferred
- The ideal candidate will be located in the Central region
- To support in the cardiovascular/electrophysiology medical device space.
- Electrophysiology/cardiac medical device monitoring experience preferred, however, strong cardiology pharma monitoring experience or any background in electrophysiology will be considered in lieu of medical device monitoring experience
- 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 of our 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.
- Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
- Ability to travel up to 65%
- To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.
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:
- Various annual leave entitlements
- A range of health insurance offerings to suit you and your family’s needs
- Competitive retirement planning offerings to maximise 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
Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits
At ICON, diversity, inclusion & belonging are fundamental to our culture and values. Our rich diversity makes us more innovative which helps us better serve our people, patients, customers, and our communities. We're proud of our diverse workforce and the work we’ve done to become a more inclusive organisation. 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 through the form below.
https://careers.iconplc.com/reasonable-accommodations
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.
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