Clinical Research Coordinator bei undefined

Duties & 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.     

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.
• Ability to interact positively with study participants and others involved with the research environment. Strong written and verbal communication skills. Must possess a valid driver’s license (and if use of personal vehicle on the job is required, must also have valid personal driver’s insurance equivalent to Hawai‘i’s No-Fault Driver’s Insurance) and maintain throughout the duration of employment.
• Three (3) years of experience working in health research/clinical trials including at least one year of oncology 

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.

Skills Knowledge

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
• 100% company paid group Life/AD&D/LTD insurance 
• Employee assistance program (EAP)  
• Pet Insurance, Prepaid legal with competitive rates  

UHP Hawai‘i is an EEO/AAP employer.