Clinical Monitoring Associate (East) - Remote

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.

Exciting opporuntity for a recent graduate that is pursuing a career in clinical research!!!

What you will be doing:

• Learn and assimilate knowledge about clinical trial procedures and operations, Good Clinical Practices, and regulatory requirements.
• Support the team in basic administrative tasks and documentation, under supervision.
• Participates in site feasibility and/or pre-trial site assessment visits, providing input on site/investigator selection in collaboration with the trial team, under supervision.
• Attends investigator meetings as needed for observational purposes.
• Supports activities related to site initiation and start-up, site monitoring, site management and site-study close-out according to internal and client SOPs, working practices, working Instructions, guidelines, applicable regulations, and the principles of ICH-GCP, under supervision.
• Supports local project planning activities in conjunction with the primary Clinical Research Associate to meet recruitment targets and to deliver high quality data on time and per the monitoring plan requirements.
• Supports site staff training activities and accurate filing of documentation of training, under supervision.
• Confirms site study supplies (such as Non-IP, lab kits, etc.) are adequate for trial conduct, under supervision.
• Confirms that clinical drug supplies are appropriately used, handled, and stored and returns are accurately inventoried and documented. Arranges for appropriate destruction of clinical supplies, under close supervision.
• All Serious Adverse Events/Product Quality Complaints are to be reported within reporting timelines and documented as appropriate. The CMA will also ensure that they are consistent with all data collected and with the information in the source document under close supervision of the primary site CRA.
• Under close supervision, confirms site staff completes data entry and resolves queries within the expected timelines.
• Under close supervision, confirms accuracy, validity and completeness of data collected at trial sites
• Under close supervision, participates in the full documentation of trial related activities, in particular monitoring- confirmation letters/visit reports/follow-up letters and the upload into eTMF.; Assist in organizing and maintaining study documentation, understanding the importance of accurate record-keeping.
• Under close supervision, promptly communicates relevant issues and status information to appropriate trial team members.
• Complies with relevant training requirements to learn about compliance, safety reporting, monitoring skills, therapeutic area, sponsor processes and regulatory requirements to conduct a trial.
• Develops an understanding of the various stakeholders.
• Engage in team meetings, contribute ideas, and gain exposure to cross-functional collaboration within the work environment.
• Observe monitoring activities (site selection, site initiation, on-site monitoring, remote monitoring, and close-out visits) learning how to conduct these types of visits, interact with site personnel and document observations.

You are:

• New college graduate, graduating no more than 12 months prior to their start date, with a Bachelor’s or Master’s degree (e.g., BS, MS), in Sciences/Health Sciences or related field.
• GPA 3.0 minimum
• Maintain patient, organization, and client confidentiality

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/benefitsAt 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-accommodationsInterested 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.