Job Summary
We are seeking a dynamic and detail-oriented Clinical Research Coordinator to join our team and drive forward innovative clinical trials. In this vital role, you will coordinate all aspects of clinical research studies, ensuring compliance with regulatory standards and maintaining the highest quality of data collection. Your energetic approach will help facilitate smooth operations from patient recruitment to data management, supporting the advancement of medical knowledge and patient care. This position offers an exciting opportunity to work at the forefront of clinical development in a collaborative and fast-paced environment.
Duties
- Coordinate all phases of clinical trials, including planning, implementation, and closeout activities.
- Screen, recruit, and monitor patients or study participants, ensuring adherence to protocols and safety guidelines.
- Review medical documentation, laboratory results, and patient records for accuracy and completeness.
- Manage data collection processes using electronic medical record (EMR) systems and other data management tools in line with CDISC standards.
- Ensure compliance with FDA regulations, ICH GCP guidelines, HIPAA privacy rules, and institutional policies throughout the trial process.
- Collaborate with multidisciplinary teams to ensure seamless trial operations.
- Conduct blood sampling, phlebotomy procedures, vital signs measurement, ECG Collections and other clinical assessments as needed.
- Maintain meticulous documentation review, audit trail integrity, and regulatory submission readiness.
Requirements
- Familiarity with medical terminology, clinical laboratory procedures, blood sampling techniques, and EMR systems.
- Strong understanding of FDA regulations, ICH GCP standards, HIPAA compliance, and CDISC data standards is a plus
- Certification in Good Clinical Practice (GCP), such as an ICH GCP certificate would be preferred
- Excellent analysis skills with attention to detail for reviewing documentation and ensuring protocol adherence.
- Ability to manage multiple projects simultaneously while maintaining high-quality standards in documentation review and compliance management.
- Background in nursing or clinical laboratory work is highly desirable; phlebotomy certification is a plus.
Pay: $20.00 - $28.00 per hour
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Flexible schedule
- Health insurance
- Life insurance
- Paid time off
- Retirement plan
- Vision insurance
Work Location: In person