Start-Up CRA

ICON plc is a world-leading healthcare intelligence and clinical research organisation. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organisations. With our patients at the centre of all that we do, we help to accelerate the development of drugs and devices that save lives and improve quality of life. Our people are our greatest strength, are at the core of our culture, and the driving force behind our success. ICON people have a mission to succeed and a passion that ensures what we do, we do well.

The Start-Up CRA is accountable for site selections as well as study-specific start-up activities and deliverables of assigned sites for Phase I-IV trials within the country. Responsible for site preparation and early identification of real site needs and issues and close handover to CRA (from issue management to risk identification).

Responsibilities:

• Collaborates with Study Start-Up Manager, Study Start-Up Team Lead and global study team to ensure Study Start-Up timelines and deliverables are met according to country commitments.
• Responsible for timely start-up activities from country allocation until site activation of assigned sites
• Conducts site selection visits, verifies site eligibility for a specific study.
• Main contact for trial sites during site selection, study start-up and IRB/IEC and HA submission preparation
• Facilitates the preparation and collection of site and country level documents
• Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, etc.) for all relevant site personnel within agreed timelines.
• Supports SSU Manager in preparation of country-specific documents, e.g., ICF, patient facing materials, etc.
• Supports assigned sites in vendor set-up activities.
• Prepare and finalize site specific documents for submission.
• Negotiates investigator payments as needed.
• Supports preparation of financial contracts between the sponsor and investigational sites and investigators as needed.
• Supports preparation of audits and inspections as applicable
• Supports reduction of formal site-specific IRB/IEC deficiencies

Requirements:

• Master’s degree in Life Sciences or equivalent
• Min. 1 year of experience in start-up from a similar position in the pharmaceutical industry or Clinical Research Organisation (CRO)
• Therapeutic knowledge as applicable demonstrated understanding of diseases and treatments
• IT proficiency: MS Office, clinical trials systems
• Fluent English verbal and writing skills
• Ability to build and maintain strong working relationships with internal and external
  stakeholders
  
  
  
  Benefits of Working in ICON:
  
  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.
  
  At 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.
  
  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.