Clinical Research Associate II (Oncology)

TL;DR

Clinical Research Associate II (Oncology): Performing monitoring activities for Phase I-IV clinical trials with an accent on data integrity, patient safety, and regulatory compliance. Focus on managing investigative sites, resolving queries, and ensuring high-quality deliverables for biotech and pharma clients.

Location: Must be based in the United States, with a preference for the East Coast.

Company

A global clinical research organization supporting biotech, medtech, and specialty pharma companies in bringing breakthrough medical innovations to patients.

What you will do

• Conduct on-site and remote monitoring visits including qualification, initiation, interim, and close-out visits.
• Ensure clinical data validity and completeness in accordance with trial protocols, ICH-GCP, and ISO 14155 standards.
• Serve as the primary point of contact for investigative sites and manage query resolution.
• Support Trial Master File activities and participate in investigator meetings.
• Identify and escalate site risks and training needs to ensure project timelines and budget adherence.
• Plan and execute daily monitoring activities and produce high-quality trip reports.

Requirements

• Undergraduate degree or international equivalent required.
• Minimum of 2+ years of clinical research monitoring experience.
• Ability to travel up to 70-85% of the time.
• Must be authorized to work in the United States as a 1099 contractor.
• Strong customer-focused communication skills for interacting with sites and clients.
• Experience with oncology studies is highly prioritized.

Culture & Benefits

• Flexible work environment designed to support work-life balance.
• Opportunity to contribute to life-changing medical innovations.
• 12-month contract position with potential to transition to full-time.
• Inclusive culture that values diverse perspectives and individual contributions.