Clinical Research Associate - Oncology - California

Scorpion Therapeutics; United States; Remote; USD 91,000 - 115,000; Full time

Job summary

A leading company in clinical research is seeking a Clinical Research Associate to manage oncology trials. The role involves mentoring junior staff, developing study documents, and requires strong communication skills. Ideal candidates will have a degree in Biological Sciences and relevant experience in clinical trials.

Benefits

Health insurance offerings

Competitive retirement planning

Global Employee Assistance Programme

Flexible optional benefits

Qualifications

• Minimum of 2-3 years’ experience in monitoring clinical trials.
• Experience monitoring Oncology trials preferred.
• Knowledge of Good Clinical Practice and ICH guidelines.

Responsibilities

• Works on multiple trials within Oncology with regional travel.
• Mentors junior team members and acts as Lead SM.
• Develops site start-up documents and supports budget development.

Skills

Analytical monitoring

Communication

Leadership

Team collaboration

Education

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

Tools

CTMS

EDC

eTMF

Job description

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Clinical Research Associate Position

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

What will you be doing?

Works on multiple trials within Oncology Quality of life focus with Regional Travel.

• Demonstrated leadership, through involvement in specific initiatives when needed, and/or SME to systems and/or processes.
• Mentors/coaches junior flex team.
• Acts as Lead SM-training other SMs on study.
• Develops site start up documents for studies including SIV agenda.
• Provides SM “voice” when reviewing study documents (e.g. Monitoring Guidelines).
• Represents LTMs or SMs on SMTs/meetings.
• Takes over LTM role reports review (SQV, SMV, SCV) for sites assigned to other SMs from the same trial.
• Supports country budget development and/or contract negotiation in liaison with CCS colleagues.
• Assists with ASV.

Metrics/KPIs: Metrics/KPIs governing these services are outlined in the Quality Oversight Plan (QOP) document.

Interfaces – Primary/Other

Primary interfaces: Provider Functional Manager, Clinical Trial Assistant, Local Trial Manager and Central Study Team for assigned clinical trials. Other Interfaces: Study Responsible Physician, Regional Quality and Compliance Manager/Specialist, Local Drug Safety Officer (where required) and Site Manager team; Investigators and their delegates at site (trial personnel including study coordinators, pharmacists, etc.)

You Are

• B.S., R.N., or equivalent degree, preferably in Biological Sciences.
• Located in California near a major airport.
• Have a minimum of 2 -3 years’ experience in monitoring pharmaceutical industry clinical trials.
• Have a minimum of 1-3 years' experience monitoring Oncology trials.
• Knowledge of several therapeutic areas.
• Analytical/risk-based monitoring experience is an asset.
• Ability to actively drive patient recruitment strategies at assigned sites.
• Ability to partner closely with investigator and site staff to meet all of our study timelines.
• Ability to operate and use various systems and databases (e.g. CTMS, EDC, eTMF, various dashboards/metrics, IWRS, safety reporting).
• Possess strong communication and influencing skills to effectively manage study sites both remotely and face to face.
• Strong team member and self-starter with the ability to work independently.
• Have an in-depth knowledge of Good Clinical Practice, ICH guidelines and local regulatory requirements.
• Need to travel up to 50%.

To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

Pay Range

($91,336.00 USD – $114,170.00 USD)

Actual compensation will be determined based on factors such as geographic location, work experience, education/training, and skill level.

What ICON Can Offer You

Our success depends on the quality of our people. That’s why we’ve made it a priority to build a diverse culture that rewards high performance and nurtures talent.

In addition to your competitive salary, ICON offers a range of additional benefits. Our benefits are designed to be competitive within each country and are focused on well-being and work life balance opportunities for you and your family.

Our Benefits Examples Include

• Various annual leave entitlements.
• A range of health insurance offerings to suit you and your family’s needs.
• Competitive retirement planning offerings to maximise savings and plan with confidence for the years ahead.
• Global Employee Assistance Programme, TELUS Health, offering 24-hour access to a global network of over 80,000 independent specialised professionals who are there to support you and your family’s well-being.
• Life assurance.
• Flexible country-specific optional benefits, including childcare vouchers, bike purchase schemes, discounted gym memberships, subsidised travel passes, health assessments, among others.

Visit our careers website to read more about the benefits of working at ICON: https://careers.iconplc.com/benefits

Diversity and Inclusion

At ICON, inclusion & belonging are fundamental to our culture and values. We’re dedicated to providing an inclusive and accessible environment for all candidates. ICON 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 through the form below.

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

Apply Today

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.