Clinical Research Coordinator

University Health Partners of Hawaii•Honolulu, HI

just now

About The Position

The Clinical Research Coordinator will independently organize and manage 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). This role involves working with the clinical trial operation team to identify and inform candidate patients about available clinical protocols, enrolling consenting eligible patients, and following enrolled patients. The coordinator will collect, document, and enter data accurately and timely into case report forms, electronic medical records, and electronic data capture systems as required per protocol. They will also work with clinical operation staff to ensure standard of care procedures are identified and will be responsible for multiple functions needed to access, select, and activate protocols. Maintaining a high level of training, continuing education, quality control, and regulatory compliance for the enterprise is crucial. The position requires close collaboration with the PI and their designee, nurses, other EPCRC staff, and physicians/investigators to foster strong working relationships and ensure compliance with research conduct. The role adheres to the standards and practices of the International Conference on Harmonization for Good Clinical Practices, handles confidential information responsibly in accordance with HIPAA, and maintains required training in human subjects’ research and other UHP requirements. Compliance with all legal requirements and company policies is expected, along with performing all other assigned duties.

Requirements

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.
Three (3) years of experience working in health research/clinical trials including at least one year of oncology.
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.
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.

Nice To Haves

Relevant education, training, and professional experience in a health-related field may be considered in place of a degree.
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.
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.

Responsibilities

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.