Clinical Trial Assistant Senior H/F

CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.
trong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing
Strong planning & organizational skills, and the ability to work efficiently and effectively
Proactive, conscientious and precise in delivery of quality work even when under pressure
Flexible with high learning and change agility
Knowledge of local regulations, IND/ICH GCP - guidelines,
Accountable for local activities required in set up and for high quality execution of studies; Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out
Confirms staff availability, suitable clinical facilities, potential for per protocol patient population
Confirms ability to comply with ICH GCP and requirements for clinical studies.
Works with Study staff to carry out a local study / site level risk
Facilitates investigator’s participation in global meetings and/or may assist the study staff with organizing local investigator Participates in other study meetings as required.
Maintain good relationship with sites and ensure that critical study timelines related to monitoring activities are achieved and that recruitment targets, patient recruitment cycle times, data and audit quality and site related milestones are
Ensure that investigators and staff fully understand their roles and responsibilities with respect to regulatory requirements (ICH-GCP).
Work with the sites to ensure they address data queries in a timely Verifying that data entered in to the CRFs is consistent with patient medical notes and entered in real time.
Ensure Investigator and site staff receives safety reports and new safety information in a timely manner.
Ensure the accuracy of data collected for safety reporting (AEs, SAEs etc.), and provides such information to safety department and other relevant departments, within the required time frames.
Completes monitoring visit reports within the agreed timelines
Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).
Ensure all necessary study supplies are available at sites in a timely manner and appropriate accountability is maintained during the study. Undergraduate degree or its international equivalent in clinical, science, or health-related fieldfrom an accredited institution; a licensed health-care professional (i.e., or equivalent work experience preferred

Read, write and speak fluent English; fluent in host country language required.

• 4+ years of clinical monitoring experience required
• Knowledge of ICH and local regulatory authority regulations regarding drug
• Clinical research experience
• Knowledge of ICH and local regulatory authority regulations regarding drug
• Experience in monitoring all trial components (PSSV to COV)
• Experience in coaching/mentoring other CRA

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.
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.
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
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:
At ICON, inclusion & belonging are fundamental to our culture and values. All qualified applicants will receive equal consideration for employment without regard to race, colour, 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.