Clinical Research Associate - Oncology

Regulatory Toolkit; Detroit (MI); On-site; USD 70,000 - 100,000; Full time

Job summary

ICON Strategic Solutions seeks a Clinical Research Associate - Oncology to join our sponsor-dedicated team in Detroit, MI. You will monitor sites, manage trials, and ensure compliance with ICH-GCP, CTMS, and eTMF, while supporting patient safety and data integrity.

Travel up to 50% across the Midwest is required, with preference for candidates near Detroit. The role requires a life sciences degree or RN, 2+ years of on-site monitoring in pharma or CRO, and the ability to work legally in the

Qualifications

• 2+ years of on-site monitoring experience in pharma/CRO
• Experience monitoring oncology clinical trials
• Proficient with ICH-GCP and local regulatory requirements

Responsibilities

• Serve as primary contact between investigational sites and sponsor (Oncology).
• Conduct site visits: selection, initiation, monitoring, close-out.
• Ensure site compliance with ICH-GCP, SOPs, and regulations.
• Maintain CTMS and eTMF documentation.
• Support training and maintain compliance records.
• Monitor patient safety and AE/SAE reporting.
• Support site recruitment and retention.
• Oversee drug accountability and storage/destruction.
• Resolve data queries and ensure timely data entry.
• Escalate risks to the clinical team.
• Track site budgets and payments; collaborate with CTAs, LTMs, CTMs.

Skills

On-site monitoring experience

Communication skills

Travel willingness

Education

Bachelor's degree Life Sciences or equivalent

RN qualification

Tools

CTMS

eTMF

Job description

Clinical Research Associate - Oncology - Detroit, MI

At ICON Strategic Solutions, you will work in a sponsor-dedicated model, supported by ICON's global expertise.

As the world's largest FSP organisation, with over 90 sponsor partnerships, we offer stability, career development and a collaborative environment where your work contributes to the development of treatments that benefit patients worldwide.

What You Will Be Doing:

• Serve as the primary point of contact between investigational sites and the sponsor - Oncology

• Conduct all types of site visits, including selection, initiation, routine monitoring, and close-out

• Ensure site compliance with ICH-GCP, SOPs, and regulations

• Maintain up-to-date documentation in CTMS and eTMF systems

• Support and track site staff training and maintain compliance records

• Monitor patient safety, ensuring timely and accurate AE/SAE/PQC reporting

• Support subject recruitment and retention efforts at the site level

• Oversee drug accountability and ensure proper storage, return, or destruction

• Resolve data queries and drive timely, high-quality data entry

• Document site progress and escalating risks or issues to the clinical team

• Assist in tracking site budgets and ensuring timely site payments (as applicable)

• Collaborate with cross-functional partners including CTAs, LTMs, and CTMs

You are:

• A graduate with a Bachelor's degree in Life Sciences or equivalent, or a qualified RN

• Eligible to work in United States without visa sponsorship

• A clinical research professional with 2+ years of on-site monitoring experience in the pharmaceutical or CRO industry

• Experienced monitoring oncology clinical trials.

• Proficient in ICH-GCP, local regulatory requirements, and clinical systems like CTMS and eTMF

• A clear communicator, problem-solver, and collaborative team player

• Willing and able to travel up to 50% for on-site monitoring visits across Midwest region; preference given to candidates residing in Detroit near major HUB airports to support efficient regional travel

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.

Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.

Benefits may include:

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

Visit our careers site to read more about the benefits ICON offers.

Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.

If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.