Clinical Research Associate

Summary

We are seeking a dedicated and detail-oriented Clinical Research Associate (CRA) to support observational and prospective studies. The CRA will be responsible for site management and data monitoring of assigned clinical sites, ensuring compliance with Good Clinical Practices (GCP) and Standard Operating Procedures (SOP). This role requires strong organizational skills, independent judgment, and the ability to collaborate with cross-functional teams to ensure the success of clinical research studies.

What You'll Do

Key Responsibilities:

1. Site Selection & Initiation:

• Conduct remote site selection visits (PSV) to assess site feasibility, facilities, and staff readiness for study participation.
• Perform remote site initiation visits (SIV) to ensure sites and study staff are trained and fully prepared to conduct the study in compliance with protocol and regulations.

2. Site Management & Monitoring:

• Ensure research site investigators and personnel conduct studies in accordance with protocols, GCP guidelines, and regulatory requirements, prioritizing patient safety and ethical research conduct.
• Perform monitoring activities per the monitoring plan, including source document verification, informed consent review, and resolution of data anomalies.
• Review site records for accuracy, completeness, and compliance, including essential documents and query resolution.
• Ensure comprehensive reporting and documentation of all monitoring activities.

3. Study Support & Compliance:

• Assist in site start-up activities, including developing PSV/SIV presentation materials and supporting regulatory and site contracting teams in document collection and review.
• Review and contribute to study plans and procedures, including Monitoring Plans, Trial Management Plans, and Risk Mitigation Plans.
• Provide ongoing guidance and support to study sites to ensure adherence to study requirements and timelines.

4. Travel & Additional Responsibilities:

• Conduct on-site visits as needed (up to 10% travel required).
• Perform additional duties as assigned to support study operations.

Qualifications

• Bachelor's degree in a science-related field or equivalent experience.
• Minimum of 2 years of CRA or advanced clinical data experience.
• Substantial site management experience or equivalent clinical research experience.
• Experience with real-world evidence (RWE) or Phase IV studies preferred.
• A combination of education and relevant experience will be considered.
• Certified Clinical Research Associate is a plus.

Total Rewards

The salary estimated for this position is $62,000-92,000 per year. Compensation will vary depending on job-related knowledge, skills and experience. Actual compensation will be confirmed in writing at the time of offer.

Why Target RWE

• Fast-moving, high-growth, biotechnology company
• The opportunity to impact healthcare and improve peoples' quality of life
• Work remote / from home culture that is flexible and no-nonsense
• Smart and easy-going colleagues
• 401(K) with a company match

Hybrid role: 1 day per week in office located in Raleigh/Durham, NC or Dallas, TX