Join Our Team
We are seeking a motivated and detail-oriented Clinical Research Associate (CRA) / Clinical Monitor to join our clinical operations team. In this role, you will monitor clinical trials to ensure they are conducted in accordance with the study protocol, Good Clinical Practice (GCP), applicable regulatory requirements, and company Standard Operating Procedures (SOPs).
Duties
- Conduct site initiation visits to train staff on protocol requirements, regulatory compliance, and data collection procedures.
- Monitor clinical trial sites regularly to verify adherence to study protocols, Good Clinical Practice (GCP), and FDA regulations.
- Review and ensure accuracy of source documents (SDV), case report forms (CRFs), and other essential trial documentation.
- Manage patient monitoring activities, including verifying informed consent, recording vital signs, blood sampling, and assessing patient safety.
- Oversee data management processes by reviewing data entries for consistency and completeness in electronic medical record (EMR) systems and databases aligned with CDISC standards.
- Ensure compliance with clinical ethical guidelines, healthcare regulations such as HIPAA, and institutional policies throughout the trial lifecycle.
- Collaborate with project management teams to track study milestones, prepare progress reports, and resolve site-related issues promptly.
Requirements
- Proven experience supervising clinical trials or managing research projects within healthcare settings.
- Strong understanding of clinical development processes, including protocol review, patient recruitment, and data collection.
- Knowledge of medical terminology, blood sampling techniques such as phlebotomy, vital signs measurement, and clinical laboratory procedures.
- Familiarity with EMR systems, statistical software for data analysis, and adherence to FDA regulations and ICH GCP guidelines.
- Certification in Good Clinical Practice (GCP) from a recognized issuer or equivalent (e.g., ICH GCP certificate).
- Experience in research setting environments with a focus on compliance management and healthcare ethics.
- Excellent organizational skills with project management experience in healthcare or clinical research environments.
- Ability to review complex documentation accurately while maintaining meticulous records for audits and regulatory submissions.
- Strong communication skills to liaise effectively with investigators, sponsors, regulatory bodies, and patients.
Join us in advancing healthcare through meticulous research oversight! This role is ideal for professionals passionate about clinical trials management who thrive in collaborative environments dedicated to scientific excellence and ethical integrity. We value your expertise in ensuring that every step of the research process aligns with industry standards while supporting innovative medical breakthroughs that can transform lives worldwide.
Pay: $70.00 - $110.00 per hour
Work Location: Hybrid remote in Dallas, TX 75240
