Title: CLINICAL RESEARCH COORDINATOR
Job Summary:
The Clinical Research Coordinator (CRC) is responsible for coordinating and managing all clinical research activities in accordance with study protocols, regulatory requirements, and institutional policies. The CRC serves as the primary liaison between study participants and investigators ensuring the integrity of study data and the safety and well-being of all participants.
Job description:
- Develop, maintain study management systems and prepare for study initiation.
- Review study protocols with the Principal Investigator, including inclusion/exclusion criteria, study design, and overall requirements.
- Screen and enroll eligible study participants.
- Review the protocol, informed consent form, and follow-up procedures with participants.
- Schedule and coordinate participant visits and follow-up assessments.
- Assist investigators in assessing subject responses to therapy and managing adverse events.
- Attend study-related meetings, trainings, and sponsor visits as required.
- Maintain regular communication with the Principal Investigator, monitors, and other study personnel to ensure adherence to protocol and study timelines.
- Accurately record study data, maintain case report forms, and ensure all documentation is complete, accurate, and properly filed.
- Support audit and monitoring visits, ensuring regulatory and study compliance.
- Perform other related duties as assigned.
Requirements:
- Bachelor’s degree in Clinical Research, Science, Biology, Psychology, or a related field.
- Certification as a Medical Assistant or Phlebotomist is preferred.
- Strong understanding of medical terminology and clinical processes.
- Excellent organizational and computer skills.
- Phlebotomy experience preferred.
- Knowledge of research regulations and guidelines (FDA, OHRP, GCP, etc.) preferred.
- At least 1 year of experience in a clinical research setting is preferred.
- Excellent communication, interpersonal, and customer service skills.
- Ability to work independently as well as collaboratively within a multidisciplinary team.
- Flexible and adaptable in a fast-paced environment.
- Spanish speaking skills preferred.
Job Type: Full-time
Expected hours: 40 per week
Benefits:
- 401(k)
- Health insurance
- Paid time off
Work Location: In person