Overview
Join our dynamic clinical research team as a Clinical Research Sub-Investigator, where your expertise will drive the success of cutting-edge clinical trials. In this vital role, you will collaborate closely with Principal Investigators and study teams to ensure the integrity, compliance, and quality of research activities. Your dedication will help advance medical knowledge and improve patient outcomes through meticulous trial oversight and patient care. This paid position offers an exciting opportunity to contribute to innovative clinical development projects in a fast-paced, collaborative environment.
Responsibilities
- Assist the Principal Investigator in overseeing daily clinical trial operations, ensuring adherence to study protocols and regulatory requirements.
- Monitor patient safety by conducting regular assessments of vital signs, blood sampling, and overall health status during study visits.
- Review and verify clinical documentation, including consent forms, case report forms (CRFs), and laboratory reports for accuracy and completeness.
- Manage patient recruitment, screening, enrollment, and retention efforts while maintaining compliance with HIPAA and other privacy regulations.
- Support regulatory compliance by maintaining detailed records in accordance with FDA regulations, ICH GCP guidelines, and local institutional policies.
- Collaborate with the study team to prepare for audits, review documentation for quality assurance, and assist in training staff on GCP standards.
Skills
- Proven supervising experience in clinical research settings with a strong understanding of clinical trials management.
- Extensive knowledge of medical terminology, FDA regulations, ICH GCP guidelines, and HIPAA compliance requirements.
- Strong documentation review skills ensuring accuracy in source documents, case report forms, and regulatory files.
- Ability to monitor patients effectively while maintaining high standards of safety and confidentiality.
- Excellent analysis skills for interpreting clinical data and supporting research findings.
- Certification in Good Clinical Practice (GCP) from a recognized issuer; ICH GCP certification is preferred.
- Knowledge of clinical development processes across various phases of trials; experience in research environments is highly valued. Embark on a rewarding career path that combines scientific rigor with compassionate patient care—apply today to be part of our innovative clinical research team!
Pay: $60,447.80 - $72,797.35 per year
Work Location: In person
