Sr. CRA - Phase 1 Oncology

ICON Strategic Solutions; Tennessee; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Corporate Recruiter to lead oncology early development trials. This role emphasizes quality of life and involves regional travel, mentoring junior staff, and ensuring compliance with GCP and ICH guidelines. The ideal candidate will have substantial experience in clinical trial monitoring, particularly in oncology, and will thrive in a collaborative environment. With a commitment to diversity and inclusion, this forward-thinking company offers competitive salaries and a comprehensive benefits package focused on well-being and work-life balance. If you're passionate about making a difference in the pharmaceutical industry, this opportunity is for you.

Benefits

Health Insurance

Retirement Plans

Employee Assistance Program

Life Assurance

Childcare Vouchers

Gym Discounts

Qualifications

• 5+ years of clinical trial monitoring experience in the pharmaceutical industry.
• 1-2 years of monitoring Oncology Early Development trials, with Phase I and II experience.
• Strong knowledge of GCP, ICH guidelines, and local regulations.

Responsibilities

• Work on oncology early development trials with a focus on quality of life.
• Mentor and coach junior team members, ensuring quality metrics are met.
• Support country budget development and contract negotiations.

Skills

Clinical Trial Monitoring

Oncology Trials

Communication Skills

Analytical Monitoring

Patient Recruitment

Education

Bachelor's Degree in Biological Sciences

Registered Nurse (R.N.)

Tools

CTMS

EDC

eTMF

IWRS

Safety Reporting Systems

Job description

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Corporate Recruiter at ICON Strategic Solutions - Hiring CRAs / Embedded Model

What will you be doing?

• Work on multiple oncology early development trials with a focus on quality of life, involving regional travel.
• Demonstrate leadership by participating in initiatives and serve as SME for systems and processes.
• Mentor and coach junior team members.
• Develop site start-up documents, including SIV agendas.
• Review study documents, such as Monitoring Guidelines, providing the SM 'voice'.
• Represent LTMs or SMs in meetings and take over LTM report reviews for assigned sites.
• Support country budget development and contract negotiations with CCS colleagues.
• Assist with ASV processes.
• Ensure metrics and KPIs are met, as outlined in the QOP.

Interfaces – Primary/Other:

• Primary: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, Central Study Team.
• Others: Study Physician, Regional Quality and Compliance, Local Drug Safety Officer, Site Team, Investigators, and site personnel.

Qualifications Needed:

• Located near a major airport in the Central US region.
• Minimum B.Sc., R.N., or equivalent, preferably in Biological Sciences.
• At least 5 years of clinical trial monitoring experience in the pharmaceutical industry.
• 1-2 years of monitoring Oncology Early Development trials, with Phase I and II experience required.
• Experience in analytical/risk-based monitoring is a plus.
• Ability to drive patient recruitment and collaborate closely with investigators and site staff.
• Proficiency with CTMS, EDC, eTMF, IWRS, safety reporting systems.
• Strong communication, influencing skills, and ability to work independently.
• Deep knowledge of GCP, ICH guidelines, and local regulations.
• Willing to travel up to 40%.
• Legally authorized to work in the US without sponsorship.

What ICON can offer you:

We value diversity and high performance, offering competitive salaries and benefits focused on well-being and work-life balance, including leave, health insurance, retirement plans, Employee Assistance Program, life assurance, and optional benefits like childcare vouchers and gym discounts.

Visit our careers website for more: https://careers.iconplc.com/benefits

ICON is committed to inclusion & belonging, providing an accessible environment free of discrimination. All qualified applicants will receive equal consideration.

https://careers.iconplc.com/reasonable-accommodations

We encourage you to apply even if you don’t meet all requirements — you might be the perfect fit!

Seniority level

• Mid-Senior level

Employment type

• Full-time

Job function

• Research and Science

Industries

• Pharmaceutical Manufacturing