Clinical Research Associate III

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Title: Clinical Research Associate III
Hiring Organization: Connexion Systems & Engineering

Compensation, Benefits, and Employment Type

• Duration: 1+ year contract, possible extension
• Pay rate: $50.02–$62.53/hour
• Job Location: Durham, NC (travel required)
• Schedule: Monday–Friday | 8:00 AM – 5:00 PM
• Job#: bh19290

Description:
Our client is seeking an experienced Clinical Research Associate III to join its Clinical Operations team supporting Phase I oncology clinical trials. This is a sponsor-side role responsible for overseeing investigative sites, ensuring protocol compliance, protecting patient safety, and driving high-quality study execution.

This position is ideal for an experienced oncology CRA with direct early-phase (Phase I) monitoring experience who enjoys working collaboratively across cross-functional teams while serving as the primary sponsor representative for assigned study sites.

Responsibilities

• Serve as the sponsor-side point of contact for assigned clinical trial sites.
• Conduct site qualification, initiation, routine monitoring, and closeout visits.
• Perform both onsite and remote monitoring in accordance with ICH-GCP, FDA regulations, study protocols, and sponsor SOPs.
• Oversee informed consent, patient eligibility, treatment administration, safety reporting, investigational product management, protocol deviations, and data quality.
• Evaluate site performance and proactively identify operational and quality risks.
• Escalate issues affecting patient safety, data integrity, compliance, or study timelines.
• Partner closely with Clinical Trial Managers, CROs, investigators, and cross-functional teams to resolve study issues.
• Review monitoring documentation and ensure inspection-ready study conduct.
• Support study startup activities, site activation, enrollment, and ongoing site engagement.
• Maintain strong relationships with investigators, research coordinators, pharmacists, nurses, and site personnel.
• Travel to investigative sites as needed.

Qualifications
Required:

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field preferred.
• Minimum 5 years of clinical monitoring experience.
• Direct Phase I oncology monitoring experience is required.
• Experience with dose-escalation studies and complex oncology protocols.
• Strong knowledge of ICH-GCP guidelines and FDA regulations.
• Experience using EDC, CTMS, eTMF, and other clinical trial systems.
• Excellent communication, organizational, and critical thinking skills.
• Ability to travel regularly for site monitoring.

Preferred:

• Sponsor-side or sponsor-dedicated CRA experience.
• Experience monitoring National Cancer Institute (NCI), cooperative group, or academic oncology studies.
• Experience collaborating with CRO partners and multidisciplinary clinical teams.

If you're passionate about advancing innovative oncology therapies and thrive in a fast-paced clinical research environment, we'd love to hear from you. Apply today to learn more about this exciting contract opportunity.



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