What are the responsibilities and job description for the Clinical Research Coordinator position at Walnut Clinical Research?
Job Overview
We are seeking a highly organized and detail-oriented Clinical Research Coordinator to oversee and manage clinical trials within our research facility. The ideal candidate will play a vital role in coordinating all aspects of clinical studies, ensuring compliance with regulatory standards, and maintaining accurate documentation. This position offers an opportunity to contribute to groundbreaking Alzheimer's research, requiring a strong understanding of clinical development processes, regulatory guidelines, and data management systems.
Responsibilities
- Coordinate and supervise clinical trial activities in accordance with FDA regulations, ICH GCP standards, and HIPAA compliance.
- Manage patient enrollment, screening, monitoring, and follow-up to ensure adherence to study protocols.
- Review and verify documentation for accuracy, completeness, and regulatory compliance.
- Collect, record, and manage clinical data using Electronic Medical Records (EMR) systems and other data management tools aligned with CDISC standards.
- Conduct patient assessments including vital signs, blood sampling, phlebotomy procedures, and monitoring for adverse events.
- Ensure proper handling of biological samples and laboratory specimens in accordance with clinical laboratory protocols.
- Oversee study documentation review and maintain meticulous records for audits and regulatory submissions.
- Supervise research staff and collaborate with investigators to ensure smooth trial operations.
- Utilize statistical software for data analysis and prepare reports summarizing trial findings.
- Maintain compliance with all applicable regulations related to clinical trials management, including FDA guidelines and institutional policies.
Requirements
- Strong knowledge of clinical trials management, medical terminology, and research protocols.
- Prior experience as a CRC in interventional clinical trials
- Experience with data collection, data management, and analysis skills using statistical software.
- Familiarity with EMR systems, and regulatory requirements such as FDA regulations, ICH GCP guidelines, HIPAA privacy rules.
- Clinical laboratory experience including blood sampling and phlebotomy preferred.
- Certification in ICH GCP (Good Clinical Practice)
- Experience with cognitive assessments and neurology studies preferred
- Excellent organizational skills with attention to detail for documentation review and compliance management.
Role Highlights
- Direct collaboration with the Principal Investigator
- Involvement in cutting-edge Alzheimer's research
- Flexible schedule; part-time or full-time considered
Interested candidates: Please email CV and rater experience to
Job Type: Part-time
Work Location: In person