Study Start-Up Clinical Research Associate (Senior)

ICON plc is a world-leading healthcare intelligence and clinical research organization. From molecule to medicine, we advance clinical research providing outsourced services to pharmaceutical, biotechnology, medical device and government and public health organization's.

With our patients at the center 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.

ICON Bulgaria are currently recruiting for an experience clinical research professional with previous experience in SIVs and study start-up to work for a global pharmaceutical company.

This particular Study Start-Up CRA role is a client dedicated one where you will work exclusively on one sponsors trials and SOPs; you will work for a client that values their staff and puts an emphasis on career development.

Job Purpose:

• Site relationship management role to ensure sustainable trial start-up at site.
• The Study 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 in adherence with monitoring procedures and processes in accordance with ICH/GCP, local regulations and SOPs.
• Proactive site preparation and early identification of real site needs and issues and close handover to execution CRA for all sites is key (from issue management to risk identification).

Key deliverables and accountabilities of the role:

• • • Supports country SSU strategy in close collaboration with Study Start-Up Team
    • Accountable for timely start-up activities from country allocation until site greenlight at 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
    • Ensures that milestones (KPIs) and time schedule for study start-up are met as planned
    • Facilitates the preparation and collection of site and country level documents
    • Collects submission relevant site-specific documents (e.g., FD, CV, GCP certificates, DSL...) 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 Study Start-Up Manager and 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
    • Ensures timelines, accuracy, and quality of country and site TMF documents in study start-up to ensure TMF inspection readiness
    • Ensures adherence to financial standards, prevailing legislation, ICH/GCP, IRB/IEC, Health Authority and SOP requirements

To be successful in the role, you will have:

• Bachelor’s Degree (or equivalent)
• Independent on-site monitoring experience would be an advantage 
• Experience conducting Site Selection Visists both remotely and on-site
• Prior experience in start-up/site activation
• Ability to travel nationally
• 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 oral

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.

#LI-DS1

#LI-Remote