Clinical Research Associate 3

Clinical Research Associate III

Location: Durham, NC 27703

Pay Rate: $50.02-$62.50/hour

Schedule: Monday-Friday, 8:00 AM-5:00 PM

Job Overview
The Clinical Research Associate III (CRA III) is a sponsor-side clinical operations representative responsible for overseeing investigational sites and ensuring high-quality execution of Phase 1 oncology clinical trials. This role combines site monitoring with sponsor oversight, risk identification, CRO/vendor collaboration, and issue escalation to ensure subject safety, data integrity, protocol compliance, and study timelines.
Candidates must have direct Phase 1 oncology monitoring experience . Experience with National Cancer Institute (NCI), cooperative group, or academic oncology studies is highly preferred.
This is a contract position requiring travel to investigative sites as needed.

Key Responsibilities

• Serve as the sponsor contact for assigned clinical sites.
• Conduct on-site and remote monitoring visits, including qualification, initiation, routine monitoring, and closeout.
• Oversee informed consent, subject eligibility, treatment administration, safety reporting, investigational product management, protocol deviations, and data quality.
• ssess site performance and identify operational or quality risks.
• Escalate compliance, safety, and study issues while partnering with study teams on resolution.
• Collaborate with CROs, vendors, Clinical Trial Managers, Data Management, Medical Monitoring, Pharmacovigilance, and other cross-functional teams.
• Review CRO monitoring activities for quality, timeliness, and issue resolution.
• Support site startup, activation, training, enrollment, and ongoing engagement.
• Track protocol deviations, data queries, action items, and inspection readiness activities through resolution.
• Prepare and review monitoring reports and study documentation.
• Maintain audit and inspection readiness.
• Build strong relationships with investigators, coordinators, nurses, pharmacists, and site leadership.
• Travel to investigative sites as required.

Required Qualifications

• Bachelor's degree in Life Sciences, Nursing, Pharmacy, or a related scientific field preferred.
• Minimum 5 years of clinical monitoring experience.
• Strong oncology monitoring experience required.
• Direct Phase 1 oncology monitoring experience, including dose-escalation studies and complex safety assessments.
• Knowledge of ICH/GCP guidelines, FDA regulations, and sponsor oversight practices.
• Experience working with CROs and cross-functional clinical teams.
• Proficiency with EDC, CTMS, eTMF, and study tracking systems.
• Strong critical thinking, documentation, communication, and problem-solving skills.
• bility and willingness to travel regularly.

Preferred Qualifications

• Sponsor-side or sponsor-dedicated CRA experience.
• Experience monitoring NCI-sponsored, cooperative group, or academic oncology studies.
• Experience supporting inspection-ready clinical trials and sponsor oversight activities.

Benefits (employee contribution):

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

ll qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Rate of pay within the stated range will depend on the qualification of the applicant.