Medical Research Coordinator II

Job Overview
We are seeking a highly motivated and detail-oriented Medical Research Coordinator II to join our dynamic clinical research team. In this pivotal role, you will oversee the coordination and management of clinical trials, ensuring compliance with regulatory standards and maintaining the highest quality of data collection. Your expertise will drive the successful execution of research studies, contributing to advancements in medical science and patient care. This position offers an exciting opportunity to work at the forefront of clinical development, supporting innovative therapies and treatments.

Duties

• Coordinate and manage multiple clinical trials, ensuring adherence to study protocols, FDA regulations, ICH GCP guidelines, and institutional policies.
• Supervise research staff and collaborate with multidisciplinary teams to facilitate smooth study operations.
• Review and verify documentation such as consent forms, case report forms, and source documents for accuracy and completeness.
• Monitor patient progress through EMR (Electronic Medical Record) systems, including vital signs, blood sampling, blood pressure, and other clinical assessments.
• Conduct patient monitoring visits, ensuring participant safety, compliance with study procedures, and accurate data collection.
• Manage data entry, validation, and analysis using statistical software while adhering to CDISC standards for data management.
• Ensure proper handling of biological samples through phlebotomy procedures and blood sampling protocols in accordance with clinical laboratory standards.
• Maintain regulatory documentation, prepare reports for Institutional Review Boards (IRBs), and ensure ongoing compliance with HIPAA privacy regulations.
• Facilitate training sessions on GCP practices, FDA regulations, and study-specific procedures for research staff.
• Assist in audit preparations by reviewing documentation for compliance with ICH GCP standards and FDA requirements.

Experience

• Proven supervising experience in a clinical research setting or healthcare environment.
• Extensive knowledge of clinical trials management including protocol development, patient recruitment, and data collection processes.
• Strong understanding of medical terminology, clinical laboratory procedures, and blood sampling techniques.
• Hands-on experience with EMR systems and electronic data capture tools aligned with clinical research standards.
• Familiarity with statistical software used for data analysis in clinical trials.
• Knowledge of FDA regulations governing clinical research and ICH GCP guidelines; certification such as an ICH GCP certificate from a recognized issuer is highly desirable.
• Background in nursing or phlebotomy is advantageous; experience in blood sampling and patient monitoring is preferred.
• Ability to review complex documentation accurately while maintaining meticulous records in accordance with compliance management protocols.
• Demonstrated ability to work independently as well as part of a team in a fast-paced environment requiring excellent organizational skills. Join us to be part of a dedicated team committed to advancing healthcare through rigorous research! We value innovation, integrity, and excellence — empowering you to make a meaningful impact on patient outcomes worldwide.

Pay: $83,000.00 - $93,000.00 per year

Benefits:

• 401(k)
• Dental insurance
• Health insurance
• Life insurance
• Paid time off
• Retirement plan
• Vision insurance

Application Question(s):

• Must be local with 60 miles of Beverly Hills.

Work Location: In person