Clinical Research Coordinator - Limited Assignment

University of California, Irvine • Orange, CA

5h

About The Position

Under supervision of the Study Principal Investigator (PI), the Clinical Research Coordinator 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 conduct protocol-specific activities including recruitment, screening, consenting, administering questionnaires, answering research patient questions and schedule appointments. Communicate with and resolve protocol-related issues with the study PI and study team.

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 quality control for randomization and data entry. The incumbent will assist 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.
• Access to transportation to off-site clinical locations.
• 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
• Required to hold a valid driver's license, have a driving record that is in accordance with local policies/procedures, and/or enroll in the California Employer Pull Notice Program.
• 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

• Supports a federal grant-funded clinical trial according to Good Clinical Practices (GCP), internal standard operating procedure (SOPs), and University policies and procedures.
• 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 conduct protocol-specific activities including recruitment, screening, consenting, administering questionnaires, answering research patient questions and schedule appointments.
• Communicate with and resolve protocol-related issues with the study PI and study team.
• 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.
• 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.
• Responsible for quality control for randomization and data entry.
• Assist the PI with preparing reports including annual progress reports submitted to the NIH.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED