Clinical Research Coordinator

University Health Partners of Hawai'i; Honolulu (HI); On-site; USD 70,000 - 100,000; Full time

Benefits offered by this job

Generous time off

Health and dental coverage

Vision coverage

Flexible spending plan

Retirement plan with matching

Job summary

University Health Partners of Hawai'i in Honolulu seeks a Clinical Research Coordinator to organize early-phase cancer trials at the Ho‘ōla EPCRC. You will identify eligible patients, inform them about protocols, obtain consent, and enroll participants.

You will document data in CRFs, EMR, and EDC, ensure GCP/HIPAA compliance, and support training, quality control, and regulatory activities across trials.

Qualifications

• Bachelor’s degree in health-related field or equivalent healthcare experience.
• 3 years of experience in health research/clinical trials including at least 1 year in oncology OR 5 years in a health care clinic setting.
• Knowledge of ICH/GCP and HIPAA requirements.
• Ability to work autonomously with minimal supervision and seek guidance when needed.
• Strong organizational and written/verbal communication skills.

Responsibilities

• Organize and manage early-phase cancer trials at Ho‘ōla EPCRC.
• Identify and inform eligible patients about protocols; enroll and consent.
• Document data into case report forms, EMR, and EDC as required.
• Ensure standard of care procedures are followed and maintain training and regulatory compliance.
• Collaborate with PI, nurses, physicians to ensure compliant conduct of research.
• Adhere to GCP and HIPAA standards.
• Maintain confidentiality of patient information and participate in ongoing training.
• Perform other duties as assigned.

Skills

Autonomy

Organizational skills

Communication skills

Regulatory compliance

HIPAA awareness

Data entry accuracy

Education

Bachelor’s degree in health-related field

Advanced degree preferred

Tools

EMR systems

EDC systems

Job description

• Independently organizes and manages activities and tasks associated with the conduct of early-phase industry-sponsored and investigator-initiated cancer clinical trials in the Ho‘ōla Early-Phase Clinical Research Center (EPCRC).
• Works with the clinical trial operation team to identify and inform candidate patients about available clinical protocols, enrolls consenting eligible patients and follows enrolled patients.
• Collects, documents, and enters data accurately and timely into case report forms, electronic medical record, and electronic data capture systems as required per protocol.
• Works with the clinical operation staff to ensure standard of care procedures are identified. Responsible for multiple functions needed to access, select and activate protocols and to maintain a high level of training, continuing education, quality control, and regulatory compliance for the enterprise.
• Works closely with the PI and his/her designee, with nurses and other staff in EPCRC, and with physicians/investigators to foster strong working relationships to ensure compliance with the conduct of industry and investigator-initiated research.
• Follows the standards and practices of the International Conference on Harmonization for Good Clinical Practices.
• Handles confidential information responsibly. Maintains confidentiality of patient information in accordance with Health Insurance Portability and Accountability Act (HIPAA).
• Maintains training as required in human subjects’ research and all other requirements of UHP.
• Complies with all legal requirements and company policies.
• Performs all other duties as assigned.

Please see the attached job description for more information.

QUALIFICATION REQUIREMENTS

Education/Training/Experience

Minimum

• Bachelor’s Degree from an accredited four (4) year college or university in a health-related field, or an equivalent number of years of relevant healthcare experience. Relevant education, training, and professional experience in a health-related field may be considered in place of a degree.
• Three (3) years of experience working in health research/clinical trials including at least one year of oncology OR 5 years working in a health care clinic setting.

Preferred

• Advanced Degree from an accredited college or university in a related field.
• Previous experience of early-phase industry-sponsored and investigator-initiated cancer clinical trials is preferred.

Minimum

• Works autonomously with minimal supervision, while also understanding the boundaries of the role, responsibilities, and experience. Seeks guidance and clarification from appropriate protocol-involved personnel when necessary.
• Demonstrated knowledge in human subjects’ research and International Conference on Harmonization (ICH)
• Demonstrated knowledge in Good Clinical Practices (GCP)
• Demonstrated knowledge in Health Insurance Portability and Accountability Act (HIPAA) requirements .
• Understanding of research study designs and ethics.
• Knowledge of and experience with computers and software programs, including word-processing, spreadsheets, and databases.
• Specialized knowledge of specific cancer care sites conducting clinical trials or of job areas, such as education/training, regulatory, investigational drug accountability/storage, specimen collection/processing, database maintenance/reporting, and regulatory compliance auditing.
• Demonstrates strong organizational skills, attention to detail, accuracy, desire to learn, and timeliness of work.
• Strong and effective written and verbal communication skills, and interacts with supervisors, co-workers, and others respectfully and professionally at all times.

BENEFITS

• Generous time off benefits
• 100% employee health and dental coverage and vision
• Flexible spending plan
• Retirement plan with up to 3% dollar-for-dollar company matching contributions
• Employee assistance program (EAP)
• Pet Insurance, Prepaid legal with competitive rates