Clinical Research Coordinator

University Health Partners of Hawaii; Hawaii; Hybrid; USD 68,000 - 92,000; Full time

Benefits offered by this job

Health coverage

Dental coverage

Vision coverage

Retirement plan

EAP

Pet Insurance

Job summary

University Health Partners of Hawaii in Honolulu seeks a Clinical Research Coordinator to oversee early-phase cancer trials at the EPCRC. You will organize study activities, screen and enroll patients, and ensure accurate data entry and regulatory compliance while collaborating with PI, nurses, and physicians.

The ideal candidate has a health-related bachelor's degree and 3 years of clinical research experience or 5 years in a health care clinic; oncology exposure is preferred.

Qualifications

• Bachelor’s degree in a health-related field or equivalent healthcare experience.
• Three years of experience in health research/clinical trials including at least one year of oncology or five years in a health care clinic setting.
• Advanced degree in a related field preferred.
• Experience with early-phase industry-sponsored and investigator-initiated trials preferred.
• Autonomy with minimal supervision and ability to seek guidance when needed.
• Knowledge of ICH, GCP, HIPAA essentials.

Responsibilities

• Independently organizes and manages activity and tasks for early-phase cancer trials in EPCRC.
• Identifies and informs eligible patients about protocols; enrolls and follows enrolled patients.
• Collects and documents data into case report forms, EMR, and EDC systems per protocol.
• Ensures standard of care procedures are identified; maintains training, quality control, and regulatory compliance.
• Collaborates with PI, nurses, physicians to ensure compliance with industry and investigator-initiated research.
• Follows Good Clinical Practices (ICH/GCP) and HIPAA confidentiality standards.
• Maintains training in human subjects’ research and other UHP requirements.
• Performs other duties as assigned.

Skills

Organizational skills

Attention to detail

Written communication

Verbal communication

HIPAA knowledge

ICH knowledge

GCP knowledge

Data entry

Education

Bachelor’s Degree in health-related field

Three years of health research/clinical trials experience ( Oncology preferred)

Advanced degree preferred

Tools

Computers and software (word processing, spreadsheets, databases)

Job description

If you are unable to complete this application due to a disability, contact this employer to ask for an accommodation or an alternative application process.

Clinical Research Coordinator

40hrs/wk 1.00 FTE Full-Time Professional Honolulu, HI, US

Salary: $80,000.00 Annually

APPLICANTS MUST RESIDE IN HAWAII

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.

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

UHP Hawai‘i is an EEO/AAP employer.

Attachments (1)

Clinical Trials Clinical Research Coordinator JD_080526.pdf