Senior CRA (Oncology) - Midwest, US

Overview

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

Responsibilities

Working fully embedded within one of our pharmaceutical clients, with the support of ICON right behind you, you'll be at the heart of our client's innovation. As a Senior Clinical Research Associate, you will be dedicated to one of our global pharmaceutical clients; a fast-growing biotech company with one of the most exciting product pipelines in the industry.

This global client develops breakthrough innovative medicines to improve and extend people's lives with targeted therapies for cancer. Join the fight against cancer at this sponsor who is running more than 60 clinical trials globally in the area of solid tumors and hematologic cancers.

Position Overview:

The Clinical Research Associate is ultimately responsible for the successful management of investigator sites and monitoring activities for assigned clinical studies throughout the trial lifecycle.

• Full ownership of investigator sites for assigned studies, with responsibility for the successful management of the site right through to close-out, in accordance with the clinical monitoring plan.
• Conducts monitoring (pre-study, initiation, routine monitoring and closeout visit), Quality Oversight Visits and co-monitoring visits if required
• Conducts co-monitoring visits, if required
• Ensures that study milestones for sites responsible are met as planned (i.e., study startup, recruitment, database analyses, closeout, etc.)
• Assists with investigator/site identification, Ethics Committee submissions, site contract and budget negotiation
• Provides protocol and related study training to assigned sites
• Developing effective relationships with investigator site staff to ensure that key clinical metrics are met.
• Ensuring integrity of clinical data through an ability to sufficiently maintain site tracking records and working diligently to relevant guideline.

Qualifications

Qualifications:

• Undergraduate degree or international equivalent in clinical, science, or health-related field from an accredited institution; health care professional licensure, i.e., registered nurse
  • Equivalent combination of education, training and relevant experience may be considered in place of the education and experience stated above. All employees must read, write and speak fluent English and host country language.
• 4 years of experience supporting clinical trials including 3 years of on-site monitoring experience (for a Senior CRA); 
  • or 2 years of experience supporting clinical trials including 1 year of on-site monitoring experience (for a CRA II)
• Prior experience of working in investigator site management, including conducting monitoring visits, from either a pharmaceutical company or a CRO environment;
• Experience in oncology studies is an absolute requirement;
• A working knowledge of ICH-GCP guidelines and local and international regulatory requirements is essential;
• Fluent in English plus local language requirements

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.