Clinical Research Coordinator Assistant - Limited Assignment

University of California, Irvine•Orange, CA

About The Position

Under supervision of the Study Principal Investigator (PI), the Clinical Research Coordinator Assistant supports a federal grant-funded clinical trial according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures. The incumbent is responsible for supporting and coordinating all aspects of this clinical trial for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping. Attends clinic to assist the PI with protocol-specific activities including recruitment, screening, consenting, administering questionnaires, answering research patient questions and schedule appointments. The incumbent is responsible for serving as a liaison between the PI, other study staff, UCI services, and the data team to help ensure that project milestones are met. The incumbent is responsible for continually reviewing the study progress and reporting to the PI in a timely fashion to ensure the study will run in accordance with the projected timeline. The incumbent is responsible for assisting the PI with preparing reports including annual progress reports submitted to the NIH.

Requirements

Ability to establish and maintain effective working relationships across the Health System.
Ability to maintain a work pace appropriate to the workload.
Must demonstrate customer service skills appropriate to the job.
Excellent written and verbal communication skills in English.
Must possess the skill, knowledge and ability essential to the successful performance of assigned duties.
Proven ability to research, properly evaluate information, and prepare clear, concise and well-organized reports, summaries, and correspondence; ability to think critically, compile data from various sources, analyze and synthesize data/information and present it to others in a clear and concise way.
Proven organizational skills and attention to detail; ability to multi-task, prioritize a complex and dynamic workload, meet rigid deadlines despite interruptions, frequent workload changes and competing demands, and achieve high productivity/quality within short time frames; skill in working independently, taking initiative and following through on assignments and ability to work as part of a team.
Proven ability to analyze and solve problems, implement solutions, and resolve concerns that arise unexpectedly.
Proven ability to independently exercise discretion and sound judgment.
High level of integrity and honesty in maintaining confidentiality.
Proven ability to maintain flexibility and adaptability.
Proven ability to establish and maintain files and records.
Working knowledge of computer software including Microsoft Office.
Proven ability to establish and maintain cooperative and collegial working relationships; demonstrated skill in interacting with the public, faculty and staff of various social, cultural, economic and educational backgrounds.
HS graduation and sufficient experience and demonstrated skills to successfully perform the assigned duties and responsibilities.
A minimum of 1 year of related work experience as a clinical research coordinator (CRC) or an assistant CRC with a Bachelor’s degree or equivalent experience
Demonstrated track record of human subjects research (Phase I, II, III drug trials, and device trials) coordination, informed consent procedures and documents, and IRB submissions
Experience working in a medical/clinical setting and familiarity with medical terminology
Must be able to provide proof of work authorization

Nice To Haves

Working knowledge of various types of human subject clinical trials (i.e. National Group, Industrial, and Investigator-authored).
SOCRA or ACRP Certification preferred

Responsibilities

supporting and coordinating all aspects of this clinical trial for protocol specific requirements, research procedures, research chart preparation, data collection, and record keeping.
Attending clinic to assist the PI with protocol-specific activities including recruitment, screening, consenting, administering questionnaires, answering research patient questions and schedule appointments.
serving as a liaison between the PI, other study staff, UCI services, and the data team to help ensure that project milestones are met.
continually reviewing the study progress and reporting to the PI in a timely fashion to ensure the study will run in accordance with the projected timeline.
assisting the PI with preparing reports including annual progress reports submitted to the NIH.