About the role

Aplyr's Quick Take

This role is for a Clinical Research Associate focused on oncology trials, primarily acting as the liaison between clinical sites and the sponsor. Day-to-day tasks include site visits, ensuring compliance, monitoring patient safety, and managing documentation. It's an individual contributor role that requires travel for site monitoring.

Good fit

Ideal candidates have at least 2 years of on-site monitoring experience in the pharmaceutical or CRO industry, particularly with oncology trials. Strong communication and problem-solving skills are essential, along with a willingness to travel frequently.

Worth noting

The role requires up to 50% travel, which may be a dealbreaker for some. Preference is given to candidates based near major airports in Los Angeles for easier travel logistics.

What You Will Be Doing:

Serve as the primary point of contact between investigational sites and the sponsor - Oncology TA
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 escalate 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 trials required.
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 southeast region; preference given to candidates residing in Los Angeles, CA near major HUB airports to support efficient regional travel

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Aplyr's read

ICON plc is a leading global provider of outsourced services in the pharmaceutical industry, attracting professionals in clinical research and data management.
Synthesized from recent postings & public sources

What's promising

•ICON plc has a strong global presence, enhancing its ability to manage international clinical trials effectively.
•The company offers diverse career opportunities across various roles in clinical research and data analysis.
•ICON's focus on innovation in pharmaceutical services supports its competitive edge in the industry.

What to watch

•The pharmaceutical industry is highly regulated, which may limit flexibility in project execution.
•ICON's reliance on large pharmaceutical clients could pose risks if partnerships dissolve.
•The competitive nature of the CRO market may pressure ICON to maintain cost efficiency.

Why ICON plc

•ICON plc specializes in comprehensive outsourcing solutions, differentiating it from competitors with narrower service scopes.
•The company's integration of technology in clinical trials offers a unique advantage in data management.
•ICON's strategic acquisitions have expanded its capabilities and market reach significantly.

Aplyr’s read is generated by AI from public sources. Was it useful?

About ICON plc

ICON plc

iconplc.com

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ICON plc is a global provider of outsourced development and commercialisation services to the pharmaceutical, biotechnology, and medical device industries.