Job Summary:
The Clinical Research Associate (CRA) is a specialized research professional working with and under the direction of the clinical Principal Investigator (PI). The CRA supports, facilitates and coordinates the daily clinical trial activities and plays a critical role in the conduct of the study. The CRA also works  with the PI, department, sponsor, and institution to support and provide guidance on the administration of the compliance, financial, personnel and other related aspects of the clinical study.

Essential Duties and Responsibilities:
• Coordinates with Principal Investigator and school, department and central administration to help endure the clinical research and related activities are performed in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Assists the PI in development of materials and tools necessary to appropriately train individuals involved in the conduct of the study around issues related to (but not limited to) protocol requirements, schedule of visits, execution of research plan. Maintains documentation of training.
• Assists Principal Investigator to assure that all key personnel or persons ‘engaged’ in the research project have met training requirements in accordance with federal regulations and university and sponsoring agency policies and procedures.
• Cooperates with university compliance and monitoring efforts related to sponsored program administration and reports instances of noncompliance to the appropriate compliance office.Coordinates and facilitates monitoring and auditing visits. Notifies appropriate institutional officials of external audits by FDA and sponsors.
• Collaborates with PI and institution to respond to any audit findings and implement approved recommendations.
• Cooperates with university and sponsoring agency compliance and monitoring efforts related to human research participant protection and reports instances of noncompliance to the appropriate compliance office.
• Reviews and develops a familiarity with the contract or award terms and conditions. Works with the PI to assure that the study is in compliance with all terms and conditions, including but not  limited to education, UOG-Institutional Review Board (IRB), UOG-Privacy Review Board (PRB) approval, conflict of interest disclosure, health and safety protections for participants and staff and any financial terms or conditions.
• Reviews and develops a familiarity with the protocol, e.g., study proceedings and timelines, inclusion and exclusion criteria, confidentiality, privacy protections.
• Assists PI in communication of study requirements to all individuals involved in the study. Provides appropriate training and tools for study team members. Documents date of training and signatures of study personnel trained on study specific training log.
• Collects documents needed to initiate the study and submit to the sponsor (e.g., FDA Forms 1572, CVs, etc.).
• Works with the PI to develop and implement recruitment strategies in accordance with UOG IRB/PRB requirements and approvals.
• Conducts or participates in the informed consent process including interactions with the UOG RB/PRB and discussions with research participants, including answering any questions related to the study. Obtains appropriate signatures and dates on forms in appropriate places. Assures that amended consent forms are appropriately implemented and signed.
• Screen subjects for eligibility using protocol specific inclusion and exclusion criteria, documenting each potential participant’s eligibility or exclusion.
• Registers participants to the appropriate coordinating center.
• Maintains adequate inventory of study supplies. If handling investigational drugs/devices, follows the sponsor protocol and/or University of Hawaii cancer center Policy on Investigational Drug/Device Accountability.
• Completes study documentation and maintain study files in accordance with sponsor requirements and University policies and procedures including but not limited to, consent forms, source documentation, narrative notes if applicable, case report forms and investigational material accountability forms.

Education and Experience:
1. Graduate of Associate Degree in Healthcare related field and above.
2. Minimum 1-year experience in clinical research preferred but not mandatory.
3.  Very good interpersonal relationship skills and can work and relate well with co-employees, patients and customers.
4. Computer literate and very highly proficient in using MS office programs.
5. Strong ethics and a high level of personal and professional integrity.