Overview
As a CRA, you will join the world’s largest & most comprehensive clinical research organization, powered by healthcare intelligence.
Responsibilities
What will you be doing?
- Managing multiple oncology early development trials
- Focusing on quality of life with regional travel
- Demonstrating leadership through involvement in initiatives and acting as SME for systems/processes
- Mentoring and coaching junior team members
- Developing site start-up documents, including SIV agendas
- Providing input during review of study documents (e.g., Monitoring Guidelines)
- Representing LTM or SM on SMTs and meetings
- Taking over LTM report reviews for sites assigned to other SMs within the same trial
- Supporting country budget development and contract negotiations in collaboration with CCS colleagues
- Assisting with ASV activities
- Tracking metrics and KPIs as outlined in the QOP document
Interfaces – Primary/Other:
- Primary: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, Central Study Team
- Other: Study Physician, Regional Quality & Compliance, Local Drug Safety Officer, Site Manager team, Investigators, and site personnel
Qualifications
Qualifications Needed:
- Located near a major airport in Central US
- Minimum of a B.Sc., R.N., or equivalent in Biological Sciences
- 1.5-2 years’ experience in monitoring pharmaceutical industry clinical trials
- 1-3 years' experience in monitoring Oncology Early Development trials
- Experience with Oncology Phase I and II trials
- Risk-based monitoring experience is a plus
- Ability to drive patient recruitment strategies
- Strong collaboration skills with investigators and site staff
- Proficiency with systems like CTMS, EDC, eTMF, IWRS, safety reporting
- Excellent communication and influencing skills, ability to work independently
- In-depth knowledge of GCP, ICH guidelines, and local regulations
- Willingness to travel up to 40%
- Legally authorized to work in the US without future sponsorship
What ICON can offer you
We prioritize building a diverse culture that rewards performance and nurtures talent. Our benefits include:
- Various annual leave entitlements
- Health insurance options
- Retirement plans
- Global Employee Assistance Programme
- Life assurance
- Flexible benefits like childcare vouchers, gym discounts, travel passes, and health assessments
Visit our careers website for more: https://careers.iconplc.com/benefits
ICON values inclusion & belonging. We are committed to an inclusive, discrimination-free workplace. Reasonable accommodations are available for applicants with disabilities. Learn more at https://careers.iconplc.com/reasonable-accommodations. We encourage you to apply even if you’re unsure about meeting all requirements.