What are the responsibilities and job description for the Clinical Research Coordinator position at Hawaii Pacific Neuroscience?
Job Overview
We are seeking a dynamic and detail-oriented Clinical Research Coordinator to join our team and drive forward innovative clinical trials. In this pivotal role, you will coordinate all aspects of clinical research studies, ensuring compliance with regulatory standards, managing data collection, and maintaining seamless communication between research teams, participants, and regulatory bodies. Your energetic approach will help accelerate the development of new therapies and improve patient outcomes. This paid position offers an exciting opportunity to contribute to cutting-edge medical research in a collaborative environment dedicated to excellence.
Duties
- Oversee the planning, implementation, and management of clinical trials in accordance with FDA regulations, ICH GCP guidelines, and institutional policies
- Recruit, screen, and monitor study participants, ensuring adherence to protocol and safety standards
- Review and verify all study documentation for accuracy, completeness, and compliance with regulatory requirements
- Collect, record, and manage clinical data using electronic Medical Record (EMR) systems and adhere to CDISC standards for data formatting
- Conduct patient assessments including vital signs, blood sampling (phlebotomy), and monitoring of clinical laboratory results
- Supervise research staff and coordinate activities related to clinical trials management, including training on Good Clinical Practice (GCP) procedures
- Ensure compliance with HIPAA regulations to protect patient privacy and confidentiality at all times
Skills
- Proven supervising experience in clinical research settings with strong leadership capabilities
- Extensive knowledge of clinical trials management processes from protocol development to data analysis
- Proficiency in medical terminology, blood sampling techniques, and clinical laboratory procedures
- Skilled in reviewing documentation such as consent forms, case report forms (CRFs), and regulatory submissions
- Ability to monitor patients effectively while maintaining high standards of care and safety protocols
- Experience with statistical software for data analysis and interpretation of trial results
- Familiarity with FDA regulations, ICH GCP guidelines, HIPAA compliance, and CDISC standards for data management
- Clinical laboratory experience including blood sampling techniques such as phlebotomy
- Strong understanding of clinical development phases and research methodologies
- Certification in GCP from a recognized issuer (such as ICH GCP certificate) or equivalent certification in Good Clinical Practice (GCP) applicable in California or other regions
- Knowledge of EMR systems for efficient data entry and retrieval during trial conduct
- Excellent analysis skills for interpreting complex clinical data sets accurately
- Ability to manage multiple projects simultaneously while ensuring strict adherence to compliance management protocols
Join us to be part of a passionate team dedicated to advancing medical science! Your expertise will directly impact the development of new treatments while providing invaluable support to patients participating in groundbreaking research. We value your commitment to excellence and look forward to welcoming a motivated professional eager to make a difference.
Pay: $62,400.00 - $68,000.00 per year
Benefits:
- 401(k)
- 401(k) matching
- Dental insurance
- Employee discount
- Flexible spending account
- Health insurance
- Health savings account
- Life insurance
- Paid time off
- Professional development assistance
- Retirement plan
- Vision insurance
Work Location: In person
Salary : $62,400 - $68,000