Clinical Research Associate II / Sr CRA - Sponsor Dedicated - Oncology (Home-Based in Western US)

Davita Inc.; Morrisville (NC); Remote; USD 80,000 - 145,000; Full time

Job summary

A leading biopharmaceutical solutions organization is seeking a Clinical Research Associate II for a home-based role in oncology. The ideal candidate will manage site activities ensuring compliance and will play a key role in mentoring junior staff. This position offers excellent growth potential and a competitive salary package with benefits.

Qualifications

• Bachelor's degree or equivalent experience required.
• Knowledge of GCP/ICH guidelines preferred.
• Willingness to travel up to 75%.

Responsibilities

• Perform site qualification, initiation, monitoring, and close-out visits.
• Mentor junior CRAs and support training initiatives.
• Document activities and support patient recruitment.

Skills

Communication

Interpersonal skills

Adaptability to new technologies

Education

Bachelor's degree or RN

Tools

Electronic data capture

Job description

Description

Clinical Research Associate II / Sr CRA - Sponsor Dedicated - Oncology (Home-Based in Western US)

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate clinical, medical affairs, and commercial insights into outcomes to address modern market realities.

Our Clinical Development model centers on the customer and the patient. We continually seek to simplify and streamline our work to make Syneos Health easier to work with and for.

Whether in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers to help our customers achieve their goals. We are agile and driven to accelerate therapy delivery because we are passionate about changing lives.

Discover what our 29,000 employees across 110 countries already know:

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

• We develop our people through career growth, supportive management, training, recognition, and rewards.
• We foster a Total Self culture, encouraging authenticity and well-being.
• We value diversity, creating an inclusive environment where everyone belongs.

Job Responsibilities

1. Perform site qualification, initiation, monitoring, management, and close-out visits, ensuring compliance with regulations and protocols. Use judgment to evaluate site performance and escalate serious issues.
2. Verify informed consent process and protect patient confidentiality. Assess factors affecting patient safety and data integrity.
3. Assess site processes, review source documents, verify data accuracy, and resolve queries.
4. Utilize hardware and software for data review and ensure compliance with electronic data capture requirements.
5. Review and reconcile Investigator Site Files and Trial Master Files, ensuring proper archiving.
6. Document activities and support patient recruitment and retention strategies.
7. Manage project activities, timelines, and budgets at the site level. Adapt to changing priorities.
8. Act as liaison with site personnel, ensuring training and compliance.
9. Participate in meetings, prepare for audits, and support audit readiness.
10. Mentor junior CRAs and support training initiatives.
11. For RWLP studies, support site identification, data collection, and regulatory collaboration.

Qualifications

• Bachelor's degree or RN or equivalent experience.
• Knowledge of GCP/ICH guidelines and regulations.
• Strong computer skills and adaptability to new technologies.
• Excellent communication and interpersonal skills.
• Willingness to travel up to 75%.

Benefits include a range of health, retirement, and performance incentives. Salary range: $80,600 - $145,000. Actual salary based on qualifications.

Learn more at http://www.syneoshealth.com

Additional Information

Tasks and responsibilities are not exhaustive. The company may assign additional duties at its discretion. Qualifications may be considered equivalent. This description does not create a contract. The company complies with applicable laws and regulations, including the ADA.