Clinical Research Associate

This is a fully remote position, open to applicants in Texas.

📋 Description

• Act as the main point of contact at the site level for both internal and external stakeholders involved in clinical trials.

• Ensure the quality, integrity, and compliance of clinical trial sites.

• Carry out site qualification, initiation, routine monitoring, and close-out visits throughout all phases of the trial.

• Verify clinical trial data in both electronic systems and paper records to ensure accessibility, completeness, and accuracy.

• Monitor compliance with ICH GCP and local regulations, provide training and support to sites, and participate in audits and inspections.

• Foster relationships with cross-functional teams, vendors, clinical sites, and key stakeholders.

• Encourage sites to achieve enrollment and retention targets.

• Prepare and submit monitoring and administrative reports.

• Evaluate investigators and sites for their resources and capabilities; identify potential investigators and sites.

• Implement targeted, centralized, remote, and risk-based monitoring strategies.

• Identify, prioritize, and mitigate risks at both the site and study levels.

• Analyze site data and operational metrics, adjusting monitoring strategies as necessary.

• Conduct unblinded site-monitor activities when required.

• Review, reconcile, and oversee study drug/Investigational Medicinal Product (IMP).

• Assist with regulatory compliance audits, inspections, corrective and preventive actions, and start-up/submission tasks.

• Facilitate access to BMS and vendor systems and maintain internal systems for site monitoring.

• Coordinate site activities related to database locks.

• Execute timely site closure activities.

⛳️ Requirements

• A Bachelor’s degree is required, ideally in life sciences or a related field.

• A valid driver's license as required by local regulations.

• 2–3 years of relevant experience in clinical research.

• Previous employment with a Pharma/Biotech Sponsor or experience as a clinical study coordinator is preferred.

• Familiarity with the drug discovery and development process.

• Understanding of clinical research processes, regulations, and methodologies.

• Practical knowledge of medical environments and medical records management.

• Working knowledge of ICH/GCP Guidelines and applicable local laws and regulations.

• Strong analytical and critical thinking skills.

• Ability to analyze complex data sets and identify issues, trends, and outliers.

• Adaptability and eagerness to learn and apply new technologies; experience or initial knowledge of AI is strongly preferred.

• Excellent organization and time management skills.

• Ability to establish and maintain relationships with both internal and external stakeholders.

• Proficient verbal and written communication skills in English and the local language.

• Foundational understanding and awareness of diseases.

• Capacity to work independently with a high degree of autonomy.

• Ability to manage multiple protocols across various therapeutic areas.

• Proficiency with CTMS, eTMF, RBQM dashboards, Microsoft Suite, Electronic Data Capture Systems, and RBM tools/platforms such as Veeva, Medidata, and CluePoints.

• Willingness to travel up to 70%.

🏝️ Benefits

• Comprehensive benefit plans, including support for wellbeing, retirement and financial protection, as well as medical, dental, vision, life, and disability insurance.

• Flexible Time Off (FTO) available for U.S.-based exempt employees.

• 11 paid company holidays each year.

• 160 hours of paid vacation annually for eligible new hires.

• 3 optional holidays for eligible non-exempt employees, RayzeBio, and Puerto Rico employees.

• Paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs, based on eligibility.

• Annual Global Shutdown occurring between Christmas Day and New Year's Day.

• Reasonable workplace accommodations/adjustments and ongoing support available.

• Additional discretionary incentive cash and stock opportunities may be offered.