Job Description
Overview:
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.
Responsibilities:
ICON Romania are currently recruiting for an experienced CRAs to work on a range of key therapy areas of Oncology, Cardiovascular, Immunology, Neurology and Vaccines.This particular SrCRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs.
What you will be doing:
The CRA is responsible for the initiation, monitoring and closure of assigned sites in clinical studies, in compliance with sponsor's procedural documents, international guidelines such as ICH-GCP, and relevant local regulations and that the sites deliver according to their respective commitment in the individual studies.
Frontline liaison between the sponsor and sites to ensure successful collaboration, meeting sponsor's expectation on milestone and deliverables with true ownership mindset
Manages assigned study sites, conducting phase I-IV protocols according to the monitring plan and sponsor's procedures,
Performs Site Initiation Visit, ensures site personnel is fully trained on all trial related aspects
Performs continuous training for amendments and new site personnel as required. Re-trains site personnel as appropriate
Conducts continuous site monitoring activities (onsite and remote). Implements site management activities to ensure compliance with protocol, ICH/GCP, global and local regulation including
Early engagement with site on patient inventory and patient flow in advance of SIV in close collaboration with global and local study tea
Performs Site Closeout activities per SOPs and applicable regulations to ensure that site is aware of any follow up activity and archiving requirements
Establish a strong partnership and true collaboration with the site, to increase patient density and decrease issues at sites
Participates in audit organization and inspection readiness activities for monitoring and site related activities as required and ensures implementation of corrective actions within specified timelines
Collaborates with internal stakeholders and site personnel to manage data query resolution process and to ensure timely and accurate data entry
Ensures the site Investigator Folder is up to date. Responsible for collecting essential documents from site and accountable to keep sTMF(s) up to date.
Qualifications:
Requirements:
Universtity Degree
Minimum 1.5 years of independent on-site monitoring experience
Experienced in conducting all types of MVs such as: Site Selection, Initiation, Routine Monitoring and Close Out Visits both remotely and on-site
Ability to travel nationally with overnight stays
A demonstrated working knowledge of ICH/GCP Guidelines
Excellent record-keeping skills and attention to detail
Fluent in English and local language- both written and orall
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: (url removed)
ICON, including subsidiaries, is an equal opportunity and inclusive employer and 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 .
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.
Job Tags
Permanent employment, Self employment, Local area, Remote job, Flexible hours, Night shift,