CRA

As a CRA you will be joining the world’s largest & most comprehensive clinical research organisation, powered by healthcare intelligence.

What you will be doing:

• Strong written and verbal communication skills in English and local language (if applicable), good presentation, negotiation and influencing
• Ability to effectively manage multiple priorities and responsibilities of increasing scope and complexity
• Proactive, conscientious and precise in delivery of quality work even when under pressure
• Knowledge of local regulations, IND/ICH GCP - guidelines,
• Available and willing to travel as job requires
• Communicate the progress and relevant information or escalate issues of the study to the appropriate study management team
• Engage and maintain good written and verbal communication with external stakeholders 
• Accountable for local activities required in set up and for high quality execution of studies; will seek managerial or other experienced support as appropriate
• Performs operational site evaluation visits, study initiation visits, on and off-site monitoring visits at the required frequency and site close-out
• Determines the feasibility of the study protocol with reference to study complexity
• Confirms staff availability, suitable clinical facilities, potential for per protocol patient population
• Confirms ability to comply with ICH GCP and requirements for clinical studies
• Delivers appropriate training to site staff and other relevant parties, as required. Assists with web based and face to face trainings to ensure that investigators and site staff are appropriately trained in ICH GCP and study related procedures 
• Participate in global investigators and/or monitor meetings as appropriate. 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 met
• 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
• Ensure local and global clinical study tracking databases are kept current with clinical study information as required (i.e. e-track, Veeva, RAMOS).

You are:

You are:

Education required:

• Undergraduate degree or its international equivalent in clinical, science, or health-related fieldfrom an accredited institution; a licensed health-care professional (i.e., registered nurse); or equivalent work experience preferred

Skills Required

• Read, write and speak fluent English; fluent in host country language required.
• 2-4 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

Why ICON?

Our focus is to provide you with a comprehensive and competitive total reward package that comprises, not only an excellent level of base pay, but also a wide range of variable pay and recognition programs. In addition, our best in class employee benefits, supportive policies and wellbeing initiatives are tailored to support you and your family at all stages of your career - both now, and into the future.

Our success depends on the knowledge, capabilities and quality of our people. That’s why we are committed to developing our employees in a continuous learning culture – one where we challenge you with engaging work and where every experience adds to your professional development.

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, 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.

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.