Clinical Research Regulatory Specialist

Job Overview

We are seeking a highly motivated and detail-oriented Clinical Research Coordinator to join our dynamic research team. In this vital role, you will oversee the planning, coordination, and execution of clinical trials, ensuring compliance with regulatory standards and maintaining the highest quality of data collection. Your expertise will help advance innovative medical research and improve patient outcomes. We are in search of a candidate who is extremely strong on regulatory affairs. This position offers an exciting opportunity to work at the forefront of clinical development in a fast-paced, collaborative environment. The candidate must be able to work in both our Washington, DC 20037 and Annapolis, MD, 21401

Duties

• Coordinate and manage all aspects of clinical trials, including patient recruitment, scheduling, and follow-up procedures
• Ensure adherence to FDA regulations, ICH Good Clinical Practice (GCP), and HIPAA guidelines to maintain compliance throughout all trial phases
• Review and verify study documentation for accuracy, completeness, and regulatory compliance
• Monitor patient safety by conducting vital signs assessments, blood sampling (phlebotomy), and tracking adverse events
• Manage data collection, entry, and management using electronic medical record (EMR) systems and adhere to CDISC standards for data consistency
• Supervise clinical staff involved in trial activities, providing guidance on protocol adherence and documentation review
• Oversee clinical laboratory procedures and collaborate with laboratory personnel to ensure accurate sample handling and analysis skills are maintained
• Conduct patient monitoring visits, review medical histories, and ensure proper documentation of clinical findings
• Maintain detailed records of trial activities, prepare reports for regulatory submissions, and support audit readiness efforts

Experience

• Proven supervising experience in a clinical research setting or related healthcare environment
• Extensive knowledge of clinical trials management, including protocol development and regulatory compliance
• Strong understanding of medical terminology, blood sampling techniques, vital signs measurement, and clinical laboratory procedures
• Experience with data management systems, EMR platforms, and statistical software used in clinical research analysis
• Familiarity with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and CDISC standards for data interchange
• Background in nursing or phlebotomy is highly desirable; relevant certifications such as an ICH GCP certificate from a valid issuer for CA are preferred
• Demonstrated ability to coordinate multiple tasks efficiently while maintaining attention to detail in a fast-paced environment

Join us to make a meaningful impact on healthcare innovation! We are committed to fostering an inclusive environment where your skills can thrive. This paid position offers comprehensive training opportunities and the chance to develop your expertise in clinical research while supporting groundbreaking medical advancements.

Pay: $30.00 - $38.00 per hour

Benefits

• Dental insurance
• Employee discount
• Health insurance
• Paid time off

Application Question(s):

• Are you located in the Metropolitan Area?

Education

• Bachelor's (Required)

Experience

• Clinical research: 2 years (Required)
• Regulatory reporting: 2 years (Required)

License/Certification:

• GCP (Required)

Willingness to travel:

• 50% (Required)

Work Location: In person