Clinical Research Associate

Overview
Join our dynamic team as a Clinical Research Associate (CRA), where you will play a pivotal role in advancing innovative medical treatments through meticulous clinical trials management. This position offers an exciting opportunity to oversee the integrity, compliance, and progress of clinical studies, ensuring they meet rigorous regulatory standards and scientific excellence. As a CRA, you'll be at the forefront of healthcare innovation, coordinating with multidisciplinary teams to deliver high-quality data and patient care. Your expertise will directly contribute to the development of groundbreaking therapies that improve lives worldwide.

Duties

• Monitor clinical trial sites to ensure adherence to protocol, Good Clinical Practice (GCP), and regulatory requirements such as FDA regulations and ICH guidelines.
• Conduct site qualification visits, initiate visits, routine monitoring visits, and close-out visits to verify data accuracy and protocol compliance.
• Review and verify source documentation, case report forms (CRFs), and other trial-related records for completeness and accuracy.
• Manage patient recruitment, enrollment, and retention processes while ensuring informed consent procedures are strictly followed.
• Facilitate communication between investigative sites, sponsors, and regulatory bodies to resolve issues promptly.
• Oversee data collection, entry, management, and analysis using electronic medical record (EMR) systems and statistical software tools.
• Ensure all documentation complies with CDISC standards and maintains confidentiality in accordance with HIPAA regulations.
• Supervise clinical laboratory procedures such as blood sampling, phlebotomy, vital signs measurement, and patient monitoring to ensure safety and protocol adherence.
• Assist in training site staff on study protocols, documentation review processes, and compliance management strategies.
• Support clinical development initiatives by contributing to study design discussions and regulatory submissions.

Experience

• Proven supervising experience in clinical trials management or related roles within healthcare or research settings.
• Extensive knowledge of clinical research processes, including patient monitoring, data management, and documentation review.
• Strong understanding of medical terminology, clinical laboratory procedures, blood sampling techniques, and EMR systems.
• Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance standards, and CDISC data standards.
• Experience working with statistical software for data analysis and interpretation is highly desirable.
• Background in nursing or clinical laboratory work is advantageous; certification such as an ICH GCP certificate from a recognized issuer for CA is required.
• Demonstrated ability to manage multiple projects simultaneously while maintaining attention to detail and compliance standards.
• Excellent communication skills for effective collaboration with research teams, site staff, patients, and regulatory agencies. Embark on a rewarding career where your expertise fuels medical breakthroughs! We are committed to supporting your professional growth through ongoing training opportunities while fostering a vibrant work environment dedicated to innovation in healthcare research.

Pay: $25.00 - $35.00 per hour

Work Location: In person

Salary : $25 - $35