Sr. Biospecimen Coordinator

University of California, Irvine • Orange, CA

29d

About The Position

Under the supervision of the Biospecimen Lab Manager, the Senior Biospecimen Coordinator supports the clinical research efforts of the Chao Family Comprehensive Cancer Center (CFCCC) by providing comprehensive coordination and data management of specimen correlative trials according to current Good Clinical Practices (GCP), Good Laboratory Practices (GLP), internal standard operating procedures (SOPs) and University policies and procedures.

The incumbent is responsible for supporting and coordinating all aspects of the correlative specimen trials for protocol specific requirements, research procedures, research chart preparation, data collection and record keeping. Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, answer research patient questions, schedules appointments, etc.
Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed. The incumbent is also responsible for maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.

The incumbent is responsible to provide mentorship and guidance to other Biospecimen Coordinators, demonstrating best practices, and provides ongoing analysis of internal processes and provides recommendations for new policies and procedures to improve overall operational efficiency and customer service.

Requirements

• Experience working in a clinical and/or research laboratory environment
• Experience with clinical research and data collection
• Experience working with and processing biological specimens
• Experience with clinical research and data collection
• Ability to interact with the public, faculty, and staff
• Ability to establish and maintain detailed and accurate files and records
• Strong organizational and verbal communication skills
• Demonstrated high-level communication skills to convey information in a clear and concise way, synthesizing information and presenting it to others
• Demonstrated problem solving capabilities to resolve concerns that arise unexpectedly
• Demonstrated ability to research, properly evaluate information, and prepare concise, well organized reports, summaries, and correspondence
• Demonstrated ability to organize and prioritize a complex and dynamic workload
• Ability to multitask and meet deadlines, despite interruptions
• Ability to analyze problems, implement solutions and multitask
• Ability to work within a deadline-driven structure
• Working knowledge of computer software including Microsoft Office (Outlook, Word, Excel, and PowerPoint
• Working knowledge of Electronic Data Capture(EDC) and Electronic Medical Record(EMR) Systems i.e. EPIC, Medidata RAVE, Medio
• 5 to 7 Years of related work experience with Bachelor of Arts/Bachelor of Science, or equivalent experience Required

Nice To Haves

• Extensive experience with various types of human subject clinical trials (Phase I-IV) i.e.,National Group, Industrial, and Investigator-authored.
• Current nationally-recognized clinical research coordinator certification (e.g. Society of Clinical Research Associates (SOCRA), Association of Clinical Research Professionals (ACRP), etc.)

Responsibilities

• supporting and coordinating all aspects of the correlative specimen trials for protocol specific requirements, research procedures, research chart preparation, data collection and record keeping
• Attends clinic to assist the Principal Investigator (PI) with recruitment, screening, consenting, administering questionnaires, answer research patient questions, schedules appointments, etc.
• Serve as the liaison to sponsors, governing agencies and facilitate transmission of verbal and written communication to national cooperative oncology groups, pharmaceutical companies and other research entities as needed.
• maintaining communication with all elements of a multi-level research network, including attending Disease Oriented Teams (DOTs) meetings, interacting with sponsoring agencies including National Cancer Institute, and compliance and regulatory groups such as the Institutional Review Board (IRB), Food and Drug Administration (FDA), and sponsor monitors.
• provide mentorship and guidance to other Biospecimen Coordinators, demonstrating best practices, and provides ongoing analysis of internal processes and provides recommendations for new policies and procedures to improve overall operational efficiency and customer service.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees