Clinical Research Associate - Oncology Early Development - West (Field Based)

Pharmaceutical Research Associates, Inc; California, Hyde Park Township, Washington (MO, IL, District of Columbia); On-site; USD 91,000 - 115,000; Full time

Job summary

A leading clinical research organization seeks a Clinical Research Associate (CRA) to manage oncology early development trials. The role involves mentoring junior staff, ensuring quality oversight, and collaborating with various teams. Candidates should possess a B.Sc. or R.N. in Biological Sciences and relevant experience in clinical trials.

Benefits

Various annual leave entitlements

Health insurance options

Retirement planning

Global Employee Assistance Programme

Life assurance

Flexible benefits like childcare vouchers

Qualifications

• 1.5 to 2 years’ experience in monitoring pharmaceutical clinical trials.
• 1-3 years' experience monitoring Oncology Early Development trials.
• Deep knowledge of GCP, ICH guidelines, and local regulations.

Responsibilities

• Managing multiple oncology early development trials.
• Mentoring and coaching junior team members.
• Supporting country budget development and contract negotiations.

Skills

Analytical monitoring

Collaboration

Communication

Influencing

Education

B.Sc. or R.N. in Biological Sciences

Tools

CTMS

EDC

eTMF

IWRS

Safety reporting

Job description

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 serving as SME for systems and processes
• Mentoring and coaching junior team members
• Developing site start-up documents, including SIV agendas
• Reviewing study documents, such as Monitoring Guidelines, providing the SM “voice”
• Representing LTMs or SMs in meetings
• Taking over LTM report reviews (SQV, SMV, SCV) for sites assigned to other SMs
• Supporting country budget development and contract negotiations in collaboration with CCS colleagues
• Assisting with ASV processes
• Monitoring metrics and KPIs as outlined in the Quality Oversight Plan (QOP)

Interfaces – Primary/Other:

• Primary: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager, Central Study Team
• Other: Study Responsible Physician, Regional Quality and Compliance Manager/Specialist, Local Drug Safety Officer, Site Manager team, Investigators and site personnel

Qualifications

Required qualifications:

• Located near a major airport in the West Region US
• B.Sc., R.N., or equivalent degree, preferably in Biological Sciences
• 1.5 to 2 years’ experience in monitoring pharmaceutical industry clinical trials
• 1-3 years' experience monitoring Oncology Early Development trials
• Experience with Oncology Phase I and II trials
• Analytical/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 and remotely
• Deep knowledge of GCP, ICH guidelines, and local regulations
• Willingness to travel up to 40%
• Legally authorized to work in the US without sponsorship

Pay Range: $91,336.00 – $114,170.00 USD

Actual salary depends on location, experience, education, and skills.

What ICON Offers

We prioritize building a diverse culture that rewards high performance and nurtures talent. Benefits include:

• Various annual leave entitlements
• Health insurance options
• Retirement planning
• Global Employee Assistance Programme
• Life assurance
• Flexible benefits such as childcare vouchers, gym memberships, and travel discounts

Learn more about working at ICON: https://careers.iconplc.com/benefits

We are committed to inclusion and equal opportunity. If you need accommodations during the application process, please contact us via the provided link.

Interested but unsure if you meet all requirements? We encourage you to apply – you might be exactly what we’re looking for!